Key Responsibilities: Governance and Leadership Serve as back-up to the Cluster Lead as the GMP/GDP contact for the region. Maintain an effective governance structure that provides transparent oversight of quality activities and risk management. Act as a core member of the Marketing Company Quality Regional Leadership Team, contributing to strategy, prioritization, and resource planning. Lead, manage, and develop team members in a multi-layered organization; set objectives and build capabilities to deliver against global processes and local needs.

Strategy, Policy, and Quality System Execution Collaborate with the US Cluster to define and deploy the GMP & GDP strategy across markets and the commercial SET area, partnering with Commercial SET leaders, Regional Commercial Heads, and Global Patient Safety. Shape and execute the Marketing Company GMP/GDP Quality System and framework, including change control, quality events, CAPA oversight, deviation/incident management, and documentation practices. Define, implement, and monitor GMP/GDP policies and standards in market; drive global standardization, simplification, and continuous improvement of Marketing Company Quality processes.

Management Review, Performance, and Reporting Support the Marketing Company Quality Management Review (QMR) process, including preparation, execution, and escalation to Operations, Commercial, and R&D senior leadership and SET members. Contribute to compliance and performance reporting to AstraZeneca Operations Leadership for Marketing Company Quality metrics and insights. Support budget planning and management for the Marketing Company Quality organization.

Regulatory Compliance and Inspection Readiness Maintain current knowledge of country-specific regulatory requirements for manufacturing and distribution; ensure audit/inspection readiness and compliance to sustain AZ’s LTO. Lead/oversee resolution of Issue Management, FARs, BPDRs, recalls, and regulatory interactions as appropriate, ensuring timely and compliant outcomes.

US Product Quality Complaints (PQC) Leadership Act as Regional Process Champion for the PQC process. Oversee end-to-end US PQC intake, triage, and communication to supply sites, ensuring consistent, clear, and timely reporting aligned with AZ policies. Integrate across stakeholders (MCOQ Regional Process Network, US Operations, US Patient Safety, global supply sites) to ensure awareness of new programs and drive customer feedback into supply and functional teams. Partner with the AZ Information Center (AZIC) to maintain an accurate, comprehensive knowledge base aligned to US PQC policies. Collaborate with the Vendor Management Team to monitor IQVIA performance (e.g., weekly quality checks), identify opportunities, and drive improvements.

People and Capability Provide training, support, and coaching on GMP/GDP requirements and practices to Marketing Company personnel. Contribute to integration activities for divestments, acquisitions, and licensing agreements by providing Marketing Company GMP/GDP quality input for the region.

XML job scraping automation by YubHub

Your primary responsibilities will include:

• Performing necessary tasks to plan and package high-quality products on time and in the right quantities in OTC and Nutritional factories at the Myerstown site in accordance with site policies, Standard Operating Procedures (SOPs), and practices.
• Working with multidisciplinary autonomous and dynamic teams to drive operational efficiencies, best practices, adopt new technologies, and ensure continuous production process improvement.
• Embracing Dynamic Shared Ownership (DSO) principles and practices and following the VACC approach in day-to-day operations.

In addition to your technical skills, you will also be expected to:

• Support the development of a diverse, inclusive talent pool where members share and support each other to build their expertise in an autonomous team environment.
• Take personal accountability in upskilling training/coaching needs and collaborate in the development of training programs to enhance the skills of the operations cluster teams.
• Own personal training records, cross-train and coach other operators as needed, and motivate team members to continuously improve processes.
• Develop high-performance competencies such as technical skills, digital capabilities, communication, and teamwork to build a collaborative, autonomous culture.
• Foster a culture of accountability, trust, and empowerment, where each team member takes ownership of safety, quality, and performance outcomes.
• Champion continuous improvement and knowledge transfer, identifying skill gaps, proposing solutions, and supporting development initiatives.

To be successful in this role, you will need to have:

• A high school diploma or equivalent.
• Experience working in a Good Manufacturing Practices (GMP) or Standard Operating Procedures (SOP) environment.
• Demonstrated ability to work safely in a production environment with frequent production schedule changes.

Preferred qualifications include an associate degree with technical/industrial manufacturing and at least 6 months of experience using motorized & non-motorized material handling equipment.

Bayer offers a competitive salary range of $22.03-$33.05, with additional compensation possible through bonuses or incentive plans. Benefits include health care, vision, dental, retirement, PTO, and sick leave.

If you're a motivated and detail-oriented individual who is passionate about working in a fast-paced production environment, we encourage you to apply for this exciting opportunity.

XML job scraping automation by YubHub

Responsibilities

• Lead end-to-end value stream mapping. Deploy Hoshin/strategy deployment to translate targets, such as COGM, capacity, and service, into a governed portfolio. This portfolio have clear owners, milestones, risks, and benefits. Additionally, create standardized COGM/productivity dashboards and benefit tracking with Finance.

• Lead programs (cycle time, labor models, MES/EBR enablement, yield, changeovers/scheduling, deviation reduction, automation/technology insertion). Apply the AZ Lean Model (A3, VSM, standard work, daily/tier management, leader standard work, adapted SMED).

• Facilitate development of business processes for training, batch execution, deviations, and patient/lot scheduling and logistics.

• Lead Kaizen events; scale best practices across the Cell Therapy Development and Operations.

• Define basic conditions for Cell Therapy Manufacturing Sites and build capability at all levels; coach leaders and value stream owners

• Partner with Supply Chain to vein-to-vein flow, slotting, and cold-chain logistics, safeguarding Chain of Identity/Chain of Custody.

• Ensure improvements uphold safety, patient focus, and cGMP for ATMPs (including GAMP and data integrity). Partner with Quality to reduce human error and increase First Pass Success and right-first-time performance.

• Align senior leaders on priorities and resources; communicate impact through governance forums.

XML job scraping automation by YubHub

Performing identification, selection, initiation, monitoring, site data review and closeout activities/visits, as well as remote data checks, in accordance with the timelines specified in the study specific Clinical Monitoring Plan (CMP).

Driving performance at the sites by proactively identifying and ensuring timely resolution to study-related issues and escalating them as appropriate.

Training, supporting, and advising Investigators and site staff in study-related matters, including Risk Based Quality Management (RBQM) principles.

Developing recruitment plans with each site and managing and supporting enrollment to ensure sites and studies meet enrollment milestones. Documenting recruitment barriers and implementing mitigation plans.

Ensuring agreed monitoring KPIs are observed and remain within the agreed quality acceptable ranges (Action Items aging, SDV metrics, Data entry metrics, query aging, MV reports metrics, etc.).

Preparing and finalizing monitoring visit reports in CTMS and providing timely feedback to the Principal Investigator, including follow-up letters, within required timelines and in line with Alexion SOPs.

Ensuring timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, Alexion SOPs, and local requirements. Supporting/participating in regular QC checks of the eTMF.

In some countries, as required, CRAs are accountable for study start-up and regulatory maintenance. Tasks may include collection, preparation, review, and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study.

Contributing to the nomination and selection of potential investigators and assisting with feasibility activities.

Collaborating with local Medical Affairs, Medical Advisor Pipeline (MAP), and other internal stakeholders, as needed.

Following quality issue processes by escalating systematic or serious quality issues, data privacy breaches, or ICH-GCP compliance issues to Global Study team, Local study team, Country Operations Line Management, and/or Quality Group, representatives as required.

Preparing for and collaborating with the activities associated with audits and regulatory inspections in liaison with other local team members (e.g., PMCO, Country Operations Line Management, and Quality Group.

Required qualifications include:

Minimum of 1 year of CRA monitoring experience

Bachelor's degree in a related discipline, preferably in life science, or equivalent qualification

Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP

Excellent knowledge of relevant local regulations

Good medical knowledge and ability to learn relevant Alexion Therapeutic Areas

Good understanding of the drug development process

Excellent understanding of Clinical Study Management, including monitoring, study drug handling, and data management

Excellent attention to details

Excellent written and verbal communication skills

Excellent collaboration and interpersonal skills

Good negotiation skills

Demonstrates flexibility in schedule and willingness to travel (required travel may be as high as 70% during busy periods)

Valid driving license (dependent on country requirements)

XML job scraping automation by YubHub

Your responsibilities will include:

• Operating complex computer-controlled production systems, including granulation, mixing, and cleaning processes
• Ensuring the quality and safety of our products by following standard operating procedures and Good Manufacturing Practices (GMP)
• Documenting your activities in accordance with GMP requirements
• Performing routine maintenance and cleaning tasks
• Identifying and reporting any issues or anomalies during production

To be successful in this role, you will need to have:

• A strong understanding of production processes and equipment
• Excellent communication and teamwork skills
• Ability to work in a fast-paced environment with multiple priorities
• Strong attention to detail and ability to follow procedures
• Ability to lift up to 25 kg and stand for long periods

We offer a competitive salary and benefits package, including:

• A salary between €3,552 and €3,765 per month (full-time)
• Annual bonus, holiday pay, and Christmas bonus
• Access to training and development opportunities
• A positive and supportive work environment
• Opportunities for career growth and advancement

If you are a motivated and experienced professional looking for a new challenge, please submit your application. We look forward to hearing from you!

Bayer is an equal opportunities employer and welcomes applications from all qualified candidates.

XML job scraping automation by YubHub

Our vision is to transform product design, development, and characterization to enable delivery of new medicines to patients. In this role, you will lead analytical strategy and delivery for oral solid dosage (OSD) forms and, as needed, inhaled and/or parenteral products from early development through clinical supply and toward commercialization.

As the analytical project/skill lead, you will partner across formulation, engineering, biopharmaceutics, manufacturing, QA and Regulatory to deliver robust methods, efficient control strategies, and submission-ready documentation. You will also help establish and optimize OSD laboratory capabilities at the Durham site, champion laboratory automation, and encourage adoption of modern data analytics and AI/ML tools to accelerate development and interpretation.

We work, on average, a minimum of three days per week from the office. We balance the expectation of being in the office while respecting individual flexibility.

Responsibilities include, but are not limited to:

• Project leadership: Act as analytical skill lead to secure major drug product deliveries, applying a risk-based, flexible approach to prioritization, resources, and timelines across modalities and dosage forms; integrate analytical plans with global teams and external partners/CMOs.

• Analytical strategy & control: Define and own a phase-appropriate analytical control strategy aligned with CMC expectations across clinical phases; harmonize methods and embed lifecycle management to ensure robust, efficient control.

• Method development & validation: Design, develop, validate, transfer, and lifecycle manage analytical methods for OSD (e.g., HPLC/UPLC, LC–MS, dissolution, impurity profiling, stability-indicating capability); establish scientifically supported system suitability, specifications, and fit-for-purpose sample preparation; ensure readiness for GMP execution with clear documentation and analyst guidance. Support inhaled and/or parenteral methods as needed.

• Characterization & performance: Lead drug product characterization, comparability, and stability programs; direct forced degradation studies; for inhaled products where required, support aerodynamic performance assessments (e.g., impactor analysis).

• CMC & regulatory: Author and review analytical CMC content for IND/IMPD/NDA/MAA; prepare validation reports, method transfer documents, and specifications; lead responses to regulatory queries and support shelf life assignment with appropriate statistics.

• Cross-functional collaboration: Work closely with formulators, engineers, supply and manufacturing sites, QA, Regulatory, and external partners/CMOs to integrate analytical deliverables into project plans and clinical manufacturing.

• Durham lab capability & technology: Champion laboratory automation for sample preparation, method execution, and data analysis under GxP control.

• Problem-solving: Lead complex investigations, root cause analyses, and data integrity assessments; apply structured problem-solving (e.g., Six Sigma) and statistics to drive timely resolution and preventive actions.

• Digital, data & innovation: Apply DoE and statistics for method robustness and understanding; use ELN/CDS and statistical tools; promote AI/ML, chemometrics, and predictive analytics to enhance interpretation, specification setting, and development speed; enable learning and standardization across projects; chip in to patenting and/or publishing.

• Quality & governance: Ensure GxP compliance where applicable, data integrity, rigorous study design, and clear communication to governance bodies.

Minimum Qualifications:

• Bachelor’s (12+ years), Master’s (6+ years), or PhD (or equivalent experience) in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, Biotechnology, or related field.

• Significant experience in pharmaceutical analytical science with current knowledge of regulatory CMC requirements for clinical and/or marketing applications.

• Demonstrated experience in analytical development for oral solid dosage forms; additional experience with inhaled and/or parenteral products preferred.

• Consistent record leading teams and/or scientific projects within a global organization and with external partners/CMOs; ability to influence cross-functional strategies.

• Strong proficiency with chromatographic techniques (HPLC/UPLC; LC–MS), dissolution, and complementary methodologies; for inhaled products, familiarity with aerosol performance characterization is a plus.

• Hands-on experience in method development (including use of supporting software), validation, transfer, and lifecycle management under ICH guidelines and phase-appropriate frameworks.

• Experience authoring analytical CMC content for submissions and responding to regulatory queries across clinical development.

• Experience working in a GMP/GxP environment; familiarity with instrument/equipment qualification, calibration, and maintenance expectations.

• Excellent communication, customer management, and influencing skills; ability to operate confidently and collaboratively across global, cross-disciplinary environments.

• Demonstrated ability to troubleshoot technical challenges and drive data-driven decisions.

• Fundamental digital and data capability relevant to analytical development, including:

• Proficiency with multivariate experimental design and basic DoE concepts for method and process understanding

• Working knowledge of statistics for analytical science (e.g., regression, ANOVA, capability/variation analysis, stability trending, OOS/OOT investigation)

• Practical use of ELN/CDS and statistical software (e.g., JMP or Minitab) for data analysis and reporting

Preferred Qualifications:

• Strategic chromatographic and separation science leadership: define orthogonal method suites (e.g., RP, HILIC, ion exchange, SEC, SFC, CE) to secure impurity resolution and stability-indicating capability; apply LC–MS(/MS) for structure confirmation and quantitation; use multidimensional LC and targeted DoE to accelerate development and set robust specifications; harmonize methods across sites with clear comparability criteria; embed lifecycle management and coach teams through complex separations (e.g., peptides, oligonucleotides, challenging matrices).

• OSD focus: Support with establishing, equipping, and optimizing OSD test equipment and processes at the Durham site.

XML job scraping automation by YubHub

As a Production Technician I at AstraZeneca, you will have the opportunity to play a pivotal role in evolving our Supply Chain. You will be operating upstream / downstream / central services processing equipment according to established SOPs. This is your chance to be part of a team that's reimagining how we do things and creating a collective legacy.

Accountabilities: In this role, you will be responsible for the operation of processing equipment according to established SOPs, MPRs, & SPRs in accordance with cGMPs. Your duties will include solution preparation, cell culture, purification & formulation, and supporting activities. You will also train with a qualified Technician on activities related to operating process equipment with the requirement of qualification. Additionally, you will follow and execute cGMP documentation, utilize Manufacturing Execution systems (MES), contribute to problem-solving activities for non-routine activities on the production floor, and participate in continuous improvement activities for Manufacturing.

Adherence to AstraZeneca values and behaviours is expected.

Essential Skills/Experience: Production Tech I - 0-1 yrs experience with High School Diploma - Ability to work independently or in collaboration with others on assigned tasks - Ability to comply with cGMP standards - Must possess computer skills - Ability to follow instruction and directions

Essential Skills/Experience: Production Tech II - 0-1 years experience with Bachelors, >1 year with Associates, >2 years with High School Diploma - Ability to work independently or in collaboration with others on assigned tasks - Ability to follow cGMP standards - Must possess computer skills - Ability to follow instruction and directions - Prior experience with aseptic/cGMP standards -Prior experience in Bioprocessing work environment/systems/equipment operation

Desirable Skills/Experience:

• BS/BA degree preferred • Degree in STEM field • Prior experience or exposure with aseptic/cGMP standards and environment

The annual base pay for this position ranges from $56,072 to $84,108. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours.

Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles).

Benefits offered include a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans.

Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment.

If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

XML job scraping automation by YubHub

Your primary responsibilities will include providing specialized knowledge and technical support in quality assurance and control processes within the organization. You will analyze quality data, develop best practices, and advise teams on compliance with industry standards and regulations.

Additionally, you will collaborate with various departments to implement quality improvement initiatives and conduct training sessions. You will ensure compliance, accuracy, standardization, and completeness of documentation supporting products manufactured and packaged at the Myerstown site, including OTC and Nutritional facilities.

You will also support Bayer internal audits, Corporate Technical Audits, State GMP Health inspections, FDA, DEA, and foreign regulatory inspections, as required.

As a Compliance Support Documentation Specialist, you will own the accuracy and cross-functional review of IQMS documents. You will manage periodic reviews of OTC and Nutritional Manufacturing and Packaging documents, including SOPs, Form Sheets, Supplements, and Standardized Documents.

You will collaborate regularly with cross-functional leaders, SMEs, and site team members at all levels to gather input and feedback. You will partner with the Compliance Support Specialist to investigate discrepancies and deviations in accordance with site policies and procedures, including root cause analysis and corrective actions.

You will review Global SOPs, assess impact to local procedures, and define actions required to maintain compliance.

You will apply a proactive, continuous improvement mindset to enhance Safety, Quality, Compliance, Efficiency, and procedural training across the site.

You will comply with all workplace standards, safety requirements, cGMPs, OSHA regulations, SOPs, and company guidelines.

You will support training development and training effectiveness; identify and evaluate future training needs and opportunities.

XML job scraping automation by YubHub

Your primary responsibilities will include:

• Responsible for clinical manufacturing novel cell therapy drug substance within the Cell Therapy Module, CT-MOD.
• Collaborates closely with biological development (BD) and Manufacturing Science and Technology (MSAT) for new product introductions and ensures platform alignment.
• Works with a single-cell line from expansion, through differentiation and fill/finish process to manufacture a unique product using single-use technology.
• Manufactures products in various phases of product life cycles from clinical through launch.
• Responsible for all aspects of clinical manufacturing in the following areas: Solution Preparation, Cell Expansion, Cell Culture, and Final Fill and freezing.

In addition, you will:

• Ensure all activities are performed to schedule.
• Clearly understand, communicate, and manage differences in terms of documentation, sample handling, automation, cGMPs, etc. for different phases of the product life cycle.
• Author, redline, and review-controlled documents for various equipment/processes.
• Monitor and control processes using data trending and/or statistical process control.
• Work cross-functionally to ensure process is controlled and issues are escalated and investigated.
• Raise and support investigation of deviations.
• Partner cross-functionally to determine product impact and root cause.
• Implement and execute manufacturing tasks in alignment with effective corrective actions to prevent re-occurrence.
• Participate in regulatory and internal audits.
• Support commissioning and qualification of equipment.
• Participate in safety investigations for CT-MOD and always promote safe behaviors.
• Partner cross-functionally to identify and implement corrective actions.

If you have experience in pharmaceutical operations, preferably biotech or an equivalent combination of education and experience, and possess a strong understanding of FDA, EMA, etc., and cGMP requirements for pharmaceutical manufacturing, we encourage you to apply for this exciting opportunity.

We offer a competitive salary range of $64,000.00 – $97,000.00, additional compensation may include a bonus or commission (if relevant), and a comprehensive benefits package, including health care, vision, dental, retirement, PTO, sick leave, etc.

XML job scraping automation by YubHub

Based in Mount Vernon, US, the position leads a high-performing team that supports OSD platform teams and senior scientific experts, ensuring robust, reliable and innovative manufacturing performance across the product lifecycle.

In this role, the Senior Director Global OSD leads and develops a diverse technical organisation focused on delivering strong product and process performance for AstraZeneca’s commercial OSD portfolio. The position manages and coaches direct reports, building capability, engagement and succession while fostering a culture of continuous improvement and innovation.

As a key member of the North Americas Commercial Operations Leadership Team, the role shapes regional strategy, aligns cross-functional priorities and translates strategy into clear, actionable plans that drive value across the network.

The Senior Director is accountable for proactively managing product and process robustness, using data, AI and advanced analytics to generate insights and drive performance improvements.

The role develops and implements science and innovation strategies for OSD manufacturing, with particular emphasis on material science, pharmaceutics and new technology introduction in partnership with Manufacturing Technology and Product Development.

A critical part of the remit is to maintain a best-in-class technical support model for internal manufacturing sites and external partners, ensuring outstanding customer service and effective risk management.

The Senior Director sets clear direction, communicates with impact and influences at all levels to embed Lean principles, operational excellence and compliant ways of working across the function.

The role also carries financial accountability for the team’s budget, including headcount and revenue, ensuring resources are deployed effectively to deliver strategic priorities.

Operating confidently in a global environment, the Senior Director builds an organisation ready for future challenges and change, contributing significantly to the success of Operations and the commercial viability and availability of current products.

XML job scraping automation by YubHub

Your key tasks will include: Handling, transporting, balancing, and providing active, auxiliary, and hazardous substances Performing weighings using simple or complex techniques, including computer-assisted methods Preparing hormone mixtures and combining active and auxiliary substances Working and sealing in foreign-air-supplied protective suits Conducting and documenting equipment and room cleaning Reporting and supporting the resolution of issues, prioritizing when necessary Taking samples for continuous identification of raw materials (NIR) Optimizing equipment utilization under the aspect of cost-benefit thinking Complying with safety regulations of UVV BG-Chemie and reporting to your supervisor

As a successful candidate, you will have a strong understanding of production processes and be able to work independently.

We offer a competitive salary and opportunities for professional growth and development.

XML job scraping automation by YubHub

At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality.

Our Gaithersburg, Maryland facility creates life-changing medicines for people around the world. This campus employs more than 3,500 experts in our field and is only a short drive from Washington, DC.

Join our dynamic Site Validation team as a Sr Validation Engineer. The department supports all areas of clinical manufacturing including support laboratories. The areas of accountability include equipment, utilities and facilities validation, CVS and daily operational support.

Main Duties & Responsibilities:

• Execute system validations for Manufacturing, Analytical and CTUs for all functions supporting the Gaithersburg Pilot Facility including Manufacturing, Analytical Sciences, Quality Control, Facilities, and Device functions.

• Manage validation lifecycle including execution of revalidations and periodic system review.

• Manage the CVS program and execute routine CVS

• Author validation protocols, reports, SOPs and other technical documents in support of the validation program at AstraZeneca.

• Executes data integrity assessments to ensure proper data generation and security for cGMP systems.

• Assists in performing project management activities.

• Support AstraZeneca’s Audit and Inspection Program.

Education & Experience Requirements:

• Bachelor's degree in engineering or sciences with 3+ years of experience, master's degree in engineering or science with 2+ years' experience, PhD Degree in Engineering or Science with 1+ years' experience or HS Diploma with 8+ years' experience.

Why AstraZeneca?

At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognising their potential.

Join us on our journey of building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together.

XML job scraping automation by YubHub

If you're seeking a diverse and meaningful professional future where you can make a real difference with brilliant minds, we want you to join our team.

As a Mechatroniker*in (all genders), Formulation Support, you will be responsible for:

• Performing complex machine maintenance and equipment setup for production orders
• Conducting necessary machine settings, adjustments, or functional tests to ensure equipment functionality
• Performing maintenance on complex machines and equipment according to specifications
• Conducting repairs after error analysis (part exchange, part repair, and part re-manufacture)
• Taking over the operational technical support of machines and equipment within production orders
• Documenting all pending or performed maintenance activities in accordance with GMP regulations

You will be responsible for:

• Preparing and processing machine parts, tools, and consumables, as well as their maintenance
• Performing quality control checks on machine parts and tools
• Ensuring compliance with safety regulations and guidelines
• Maintaining accurate records of maintenance activities and machine performance

Requirements:

• Completed vocational training as a Mechatroniker*in or equivalent training with experience in the pharmaceutical, chemical, or food industry
• Experience in maintenance, repair, and setup
• Proficiency in PC skills; SAP knowledge and experience in a GMP-regulated environment are desirable
• Ability to capture complex processes and relationships
• Work-oriented, systematic, and responsible approach
• High quality and cost awareness, as well as high level of independence, reliability, initiative, flexibility, and teamwork
• Good communication and cooperation skills
• Willingness to work in a 3-shift system
• Fluency in German language (written and spoken)

We offer:

• A competitive compensation package consisting of a monthly salary, annual bonus, holiday pay, and Christmas bonus/13th month salary
• Opportunities for further development through access to learning platforms such as LinkedIn Learning and our language learning platform Education First
• Support for health and self-care through our health platform #machtfit
• Sustainable mobility through climate-friendly mobility options such as job ticket and bike sharing
• Exciting benefits and access to discounts from over 150 brands through our Corporate Benefits Program
• Diversity celebrated in an inclusive work environment where you are welcome, supported, and encouraged to bring your whole personality

The position is limited to 2 years with the possibility of extension. Be You. Be Bayer. #LI-AMSEMEA

XML job scraping automation by YubHub

As a Production Compliance Specialist, you will be responsible for creating and managing manufacturing instructions (MBRs) in our Manufacturing Execution System (MES), including creating MBR checklists. You will also create and review product quality reviews for the bulk production/forming area, create and manage machine recipes from production instructions, and conduct research for the forming area.

Responsibilities:

• Create and manage manufacturing instructions (MBRs) in MES, including creating MBR checklists
• Create and review product quality reviews for the bulk production/forming area
• Create and manage machine recipes from production instructions
• Conduct research for the forming area
• Create, coordinate, and implement change requests in MOC for the department
• Participate in projects and support implementation for the forming area
• Support the creation of cleaning instructions (eCRs) in MES, preparation and timely provision of production orders, and creation, reconciliation, and archiving of GMP documents for the forming area (e.g., SOPs, OIs, forms, risk analyses, etc.)

Requirements:

• Bachelor's degree in pharmacy or related field
• First-hand experience in the pharmaceutical industry, preferably in the manufacture of medicinal products and GMP documentation
• Good knowledge of GMP guidelines
• Strong quality awareness
• Proficiency in Microsoft Office applications (Outlook, Word, PowerPoint, Excel) and MES and document management systems
• High level of initiative and self-motivation
• Excellent communication and teamwork skills
• Very good German language skills and basic English language skills

What we offer:

• Competitive salary between €3,552 and €3,765 per month (full-time) plus annual bonus, holiday pay, and Christmas bonus/13th month salary
• Opportunities for further development through access to learning opportunities such as LinkedIn Learning and our language learning platform Education First
• Support for health and a self-care lifestyle
• Confirmation of sustainable mobility through climate-friendly mobility options such as job ticket and leased company bike
• Exciting benefits and access to discounts from over 150 brands through our Corporate Benefits Program
• Celebration of diversity in an inclusive work environment where you are welcome, supported, and encouraged to bring your whole personality

Further information: The position is limited to 2 years. Be You. Be Bayer#LI-AMSEMEA

XML job scraping automation by YubHub

Your main responsibilities will include evaluating quality defects and deviations in production, creating and implementing risk-mitigating measures, and supporting Good Manufacturing Practice (GMP) inspections and customer audits.

To be successful in this role, you will need to have a deep understanding of regulatory requirements and GMP guidelines, as well as excellent communication and teamwork skills.

In return, we offer a competitive salary and benefits package, including a comprehensive training program and opportunities for professional development.

If you are a motivated and detail-oriented individual with a passion for quality and compliance, we encourage you to apply for this exciting opportunity.

XML job scraping automation by YubHub

XML job scraping automation by YubHub

The Associate Director, Drug Product, will provide strategic and hands-on operational leadership for all CMC activities related to drug product development and manufacturing, with a primary focus on sterile injectables (lyophilized and liquid) at all stages of development (IND-enabling to commercialization).

Responsibilities

Development and Manufacturing Strategy, Operations and Oversight

• Lead drug product manufacturing strategy and execution for programs from preclinical through commercial stages, ensuring alignment with program objectives, timelines, and budget constraints.

• Serve as the primary technical interface with CDMOs and contract manufacturing organizations for drug product manufacturing activities. Establish and maintain strong partnerships, lead technical discussions, and ensure manufacturing excellence across external manufacturing networks.

• Oversee formulation, aseptic fill-finish, lyophilization (if applicable), visual inspection, labeling, and packaging operations for drug products. Ensure manufacturing processes are robust, scalable, and compliant with cGMP requirements.

• Provide technical guidance and oversight for manufacturing campaigns including batch record review and approval, deviation investigations, change control assessments, and resolution of manufacturing issues

• Support scale-up activities from clinical to commercial manufacturing, including process optimization and validation. Identify and implement continuous improvement opportunities.

• Develop comprehensive manufacturing plans and schedules in collaboration with Project Management, Clinical Supply, and Commercial teams. Track manufacturing timelines and proactively manage risks to ensure on-time delivery of drug product for clinical trials and commercial supply.

• Lead technical assessments and qualification of new CDMOs for drug product manufacturing. Conduct site audits and ongoing performance monitoring. Manage relationships with multiple manufacturing partners across different geographic regions

Additional Core CMC Responsibilities (Quality, Regulatory & Cross-Functional)

• Ensure all manufacturing activities comply with cGMP regulations, ICH guidelines, and internal quality standards. Support regulatory inspections and audits at manufacturing sites. Review and approve batch records, protocols, and manufacturing-related documentation.

• Author and review CMC sections of regulatory submissions (INDs, BLAs, CTAs) related to drug product manufacturing, process validation, and manufacturing site changes. Support responses to health authority questions.

• Partner closely with Drug Substance Manufacturing, Analytical Development, Quality Assurance, Regulatory Affairs, Clinical Supply, and Project Management leads to ensure seamless integration of manufacturing activities into overall program execution.

• Collaborate with procurement to ensure timely contracting for drug product manufacturing.

About You

• MS or Ph.D. in Chemical Engineering, Pharmaceutical Sciences, Biochemistry, Biotechnology, or related discipline.

• 6+ years of experience in the biopharmaceutical industry with hands-on experience in biologics drug product manufacturing, formulation development, and fill-finish operations.

• Demonstrated track record of successfully managing drug product manufacturing campaigns for biologics (proteins, monoclonal antibodies, antibody-drug conjugates, or other large molecules) from preclinical through late-stage clinical or commercial manufacturing.

• Technical expertise in aseptic fill-finish operations, lyophilization processes, formulation development, stability programs, and drug product characterization for biologics.

• Extensive experience working with CDMOs and contract manufacturing organizations, including site selection, technology transfers, manufacturing oversight, and performance management. Proven ability to troubleshoot complex manufacturing issues and drive continuous improvement initiatives.

• Strong knowledge of cGMP regulations, FDA and EMA guidelines, ICH quality guidelines, and regulatory expectations for drug product manufacturing.

• Experience authoring and reviewing CMC sections of regulatory submissions (INDs, BLAs, CTAs) related to drug product manufacturing and validation activities.

• Strong project management skills with demonstrated ability to manage multiple manufacturing programs simultaneously, meet aggressive timelines, and navigate competing priorities.

• Excellent communication and interpersonal skills with ability to influence and build strong relationships with internal stakeholders and external manufacturing partners.

• Willingness to travel domestically and internationally (approximately 20-30%) to manufacturing sites for audits, manufacturing oversight, and technical meetings.

Total Compensation Range

$177,000 - $235,000

Where We Hire

Formation Bio is prioritizing hiring in key hubs, primarily the New York City and Boston metro areas, with a hybrid model requiring 3 days per week in office. Applicants from the Research Triangle (NC) and San Francisco Bay Area may also be considered. Please apply only if you reside in these locations or are willing to relocate.

XML job scraping automation by YubHub

Associate Director, Analytical Development & QC

About the Position

We are seeking a highly motivated, self-driven and detail-oriented Associate Director of Analytical Development and Quality Control to join our CMC team.

This role will provide broad exposure across Formation Bio's portfolio, requiring the ability to flex between small molecule and biologics programs at different phases of development in an outsourced development model, requiring strong technical skillset, vendor management, and the ability to balance scientific rigor with program timelines.

Responsibilities

• In close collaboration with CDMOs and contract testing laboratories, lead development, optimisation and validation of phase-appropriate analytical methods for small molecule and biologics drug substances and drug products.
• Manage testing (in-process, release, stability) at CDMOs and contract testing laboratories.
• Provide technical oversight for method transfers, comparability assessments, and laboratory readiness.
• Lead selection, qualification, and ongoing performance management of external analytical vendors.
• Oversee and manage Formation Bio's stability studies across all programs, including review and approval of stability protocols and review and trending of stability data to support shelf-life and retest dating. Track and publish stability program metrics. Act as the primary contact for stability-related inquiries.
• Oversee and manage Formation Bio's critical reagents and reference standards inventory and testing.
• Lead investigations of release and stability OOS and OOT results, deviations, CAPAs and change controls.
• Author and review analytical sections of CMC documents, including protocols, reports, and regulatory submissions.
• Author and review of SOPs and work instructions.
• Closely collaborate with CMC, QA, and Regulatory teams.

About You

• Analytical Chemistry, Biochemistry, Molecular Biology, or a related discipline Master's degree with 5+ years or Bachelor's Degree with 8+ years of relevant small molecule and biologics analytical development and QC experience.
• Proven ability to operate effectively in a fast-paced, virtual, and outsourced development environment.
• Highly organised with a track record of managing multiple priorities across programs in an outsourced development model.
• Strong scientific judgement with the ability to independently assess data quality, identify risks, and recommend mitigation strategies.
• Ability to communicate complex analytical concepts clearly to both technical and non-technical stakeholders.
• Collaborative mindset with a strong sense of ownership and accountability.
• Extensive hands-on experience developing, optimising, and validating analytical methods for release and stability testing of small molecules and biologics.
• Hands-on experience with analytical methods pertinent to bilogics (qPCR, IEF, UHPLC, MS, CE, SDS-PAGE, ELISA, peptide mapping, glycan analysis, etc.) and small molecules (UHPLC, IC, GC, IR, UV, KF, PSD, dissolution, etc.).
• Experience with authoring and reviewing technical documents such as test methods, method development reports, validation protocols, validation reports, specification justification reports, retest and shelf-life memos, and SOPs.
• Experience with designing stability studies and performing stability data trending according to applicable guidances.
• Strong working knowledge of Smartsheet and JMP.
• Thorough understanding of ICH, FDA, EMA guidances and GMP requirements governing process development, manufacturing, and stability.
• Ability to travel domestically and internationally up to 25% of the time.

Total Compensation Range

$177,000 - $235,000

Where We Hire

Formation Bio is prioritising hiring in key hubs, primarily the New York City and Boston metro areas, with a hybrid model requiring 3 days per week in office. Applicants from the Research Triangle (NC) and San Francisco Bay Area may also be considered. Please apply only if you reside in these locations or are willing to relocate.

XML job scraping automation by YubHub

This role will involve new technology implementations and managing the support of current infrastructure including working with supporting vendors.

The Senior Manager, IT infrastructure will have a deep and broad knowledge of networking, virtualization, server, storage, and operating system technologies, both on-premise as well as in the GCP cloud.

This position will work closely with the Information Security team to ensure a compliant and secure infrastructure environment.

The role reports to the Director, IT. This role will be a Hybrid role.

Responsibilities:

• Leads team of network engineers, system administrators, lab system administrators to support Freenome infrastructure (On prem, Labs and GCP).
• Problem Solving, collaboration, solid comprehension of cloud, virtualization, storage, networking, software and hardware, strategic planning, leadership, mentorship, creating and giving presentations.
• Identify, create, and apply process improvement to increase product and service quality to achieve business objectives.
• Contributes to defining the department's long-term strategy and goals.
• Collaborate with the Help desk and Business Application team to define and implement the infrastructure needed for day to day operations.
• Ensures data security and disaster recovery protocols are in place. Ensuring compliance with regulatory requirements.
• Develops and creates standardized processes and procedures to guide documentation and knowledge base development for IT infrastructure operations support.
• Develops and supports standards for enterprise-wide use of resources. Recommends enterprise level strategies and goals for infrastructure hardware and software procurement and deployment. Writes detailed scopes of work for staff projects.
• Plan, communicate, and deploy changes to IT infrastructure per standard change management process and scheduled maintenance windows. Coordinate IT change and maintenance activities with business stakeholders.
• Maintains IT infrastructure and network diagrams, asset/equipment inventory and IT change/incident logs.
• Supports IT audits and conduct IT systems/network vulnerability scanning, patching and hardening.
• Manage external vendor relationships.

Must haves:

• 7+ years’ experience in a technology leadership/management role.
• Strong management and technical skills, most notably architect-level skills in virtualization, systems administration, scalable upgrade and migration strategies, networking, and storage. Possess the technical expertise with virtualization and network infrastructure technologies such as VMware vSphere, LAN and WAN.
• 5+ years of experience managing or maintaining enterprise IT infrastructure (Network, IaaS, PaaS, and/or Security).
• Experience in a continuous improvement environment with a track record of achieving significant continual development.
• Strong project management, problem solving, organizational, relationship, communication, and negotiation skills (oral and written) are required.
• 7+ years of experience with Windows 10/11, Windows server, DAS/NAS/SAN, Google workspace, and GCP.
• Strong knowledge of security access controls, policies, groups, rights, and permissions.
• Familiarity with IT GRC (BCDR, ITSM/ITIL, SOX, ISO, PCI, HIPAA, GMP, GDPR, FDA 21 CFR Part 11).
• Ability to document and explain complex technical solutions to management and other non-technical staff.
• Strong customer service and time management skills, with the ability to work effectively in a dynamic, and fast-paced environment.
• Flexibility to work weekends and after hours for IT projects/maintenance (on occasion).

Nice to haves:

• Bachelor's degree in MIS/CIS, Computer Science or equivalent professional experience.
• Industry certifications such as ITIL, CCNA, MCITP, MCSA, MCSE, VCP, Cloud+, Security+ preferred.
• Experience with GMP systems and IT systems change management process.
• Experience with Juniper, Meraki, Netapp, VmWare, and Google workspace.

Benefits and additional information:

• The US target range of our base salary for new hires is $180,975 - $232,575.
• You will also be eligible to receive equity, cash bonuses, and a full range of medical, financial, and other benefits depending on the position offered.
• Please note that individual total compensation for this position will be determined at the Company’s sole discretion and may vary based on several factors, including but not limited to, location, skill level, years and depth of relevant experience, and education.
• We invite you to check out our career page @ https://freenome.com/job-openings/ for additional company information.

Freenome is proud to be an equal-opportunity employer, and we value diversity. Freenome does not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.

Applicants have rights under Federal Employment Laws.

• Family & Medical Leave Act (FMLA)
• Equal Employment Opportunity (EEO)
• Employee Polygraph Protection Act (EPPA)
• #LI-HYBRID

XML job scraping automation by YubHub

Responsibilities:

• Cycle counting to ensure accurate inventory levels
• Sticker and labeling of products for easy identification
• Construction of coolers to store temperature-sensitive materials
• Preparation of supplies for distribution
• Management of supplies to ensure efficient use
• Disposal of garbage in accordance with GMP processes
• Staging of materials for destruction
• Receipt of supplies
• Special projects as assigned
• Assist with conduct of Special Security Substances (SSS) Inventories

Keywords provides a competitive compensation package, good benefits and a casual, fun, productive and supportive working environment. We empower people to perform to the best of their ability with our “can do” attitude. We appreciate and embrace flexibility and learn at every opportunity to grow ourselves through experience, training and tackling new challenges.

This is what makes us Keywordians.

Requirements:

• Strong organization and multi-tasking ability
• Experience with inventory management, preferably in a clinical trial setting
• Good communication skills
• Ability to work in a collaborative team environment
• Strong attention to detail
• Willingness to pick orders up to 25 feet on forklift and cherry picker (training will be provided)
• Experience in a regulated industry, preferably pharmaceutical
• Ability to bend and lift 50 pounds
• Ability to stand for 8 hours daily
• High school diploma
• Basic computer skills
• Demonstrate high productivity with minimal supervision
• Proficiency in inventory software, databases and systems highly desirable
• Ability to work up to 8 hours in 42 degrees

Benefits: Keywords provides all its contingent workforce with:

• Medical, dental and vision benefits
• Paid time off (including sick and select holidays)
• 401(k) enrollment with 3% employer matching

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law

XML job scraping automation by YubHub

XML job scraping automation by YubHub

San Francisco

Employment Type

Full time

Location Type

Hybrid

Department

Consumer Products

Compensation

• $293K – $325K • Offers Equity

The base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. If the role is non-exempt, overtime pay will be provided consistent with applicable laws. In addition to the salary range listed above, total compensation also includes generous equity, performance-related bonus(es) for eligible employees, and the following benefits.

• Medical, dental, and vision insurance for you and your family, with employer contributions to Health Savings Accounts

• Pre-tax accounts for Health FSA, Dependent Care FSA, and commuter expenses (parking and transit)

• 401(k) retirement plan with employer match

• Paid parental leave (up to 24 weeks for birth parents and 20 weeks for non-birthing parents), plus paid medical and caregiver leave (up to 8 weeks)

• Paid time off: flexible PTO for exempt employees and up to 15 days annually for non-exempt employees

• 13+ paid company holidays, and multiple paid coordinated company office closures throughout the year for focus and recharge, plus paid sick or safe time (1 hour per 30 hours worked, or more, as required by applicable state or local law)

• Mental health and wellness support

• Employer-paid basic life and disability coverage

• Annual learning and development stipend to fuel your professional growth

• Daily meals in our offices, and meal delivery credits as eligible

• Relocation support for eligible employees

• Additional taxable fringe benefits, such as charitable donation matching and wellness stipends, may also be provided.

More details about our benefits are available to candidates during the hiring process.

This role is at-will and OpenAI reserves the right to modify base pay and other compensation components at any time based on individual performance, team or company results, or market conditions.

About the Team

The Connectivity Software Engineering team is responsible for enabling seamless, secure, and high-performance wireless connectivity across OpenAI’s products. We design and optimize Bluetooth, BLE, Wi-Fi, and emerging wireless technologies to ensure robust device pairing, network performance, and interoperability. Our work spans kernel drivers, system services, and user-level tools, with a focus on real-world performance, scalability, and reliability.

About the Role

OpenAI is seeking a Connectivity Software Engineer to design, implement, and optimize wireless connectivity features across our product ecosystem. You’ll work at the intersection of systems software, wireless standards, and hardware integration—building robust pairing and provisioning flows, debugging low-level protocols, and driving performance under real-world RF constraints. You will also support certification, field interoperability, and fleet-scale connectivity infrastructure.

This role is based in San Francisco, CA. We use a hybrid work model of 4 days in the office per week and offer relocation assistance to new employees.

In this role, you will:

• Design, implement, and debug Bluetooth/BLE and Wi-Fi features across kernel drivers, BlueZ/wpa\_supplicant/hostapd, and systemd/D-Bus services

• Deliver robust pairing, bonding, and provisioning flows (GATT/GAP, LE Audio/LC3, WPA3/802.1X, captive portals, NAN)

• Optimize link performance: throughput, latency, jitter, roaming, coexistence (BT↔Wi-Fi), and power modes (TWT, WoWLAN)

• Build reliable network management using NetworkManager/nmcli, nl80211/cfg80211/mac80211, DNS/DHCP/mDNS, P2P/SoftAP

• Instrument and analyze with packet captures and tooling (btmon/hcidump, Wireshark, iperf, eBPF/perf, spectrum sniffers)

• Drive interoperability and certification readiness (Bluetooth SIG, Wi-Fi Alliance) and resolve field issues with root-cause fixes

• Contribute to OTA-safe configuration, telemetry, and diagnostics for fleet-scale operation

You might thrive in this role if you:

• Have deep experience shipping wireless features on Linux-based products

• Are highly proficient in C/C++ with scripting experience (Python or shell) and systems debugging (gdb, strace, logs, packet traces)

• Possess deep knowledge of Bluetooth Classic/BLE (HCI, L2CAP, GATT/GAP, profiles) and Wi-Fi (802.11 a/b/g/n/ac/ax, WPA2/3, nl80211, NAN)

• Bring hands-on experience with BlueZ, wpa\_supplicant/hostapd, NetworkManager, and driver bring-up on ARM64 or x86 platforms

• Have a proven track record of improving real-world performance and reliability under RF constraints

Preferred qualifications:

• Experience with LE Audio (LC3), BLE Mesh, advanced roaming (802.11k/v/r), QoS/WMM, multicast/IGMP

• Coexistence tuning across radios (BT/Wi-Fi/UWB/mmWave) and antenna/RF fundamentals with test equipment workflows

• Familiarity with UWB (IEEE 802.15.4z, FiRa) ranging/integration; mmWave/Wi-Gig (802.11ad/ay)

• Experience with security and provisioning at scale (EAP-TLS, device identity, secure boot, disk/network hardening)

• Background in building factory test, interoperability, and certification test plans; upstream/open-source contributions

About OpenAI

OpenAI is an AI research and deployment company dedicated to ensuring that general-purpose artificial intelligence benefits all of humanity. We push the boundaries of the capabilities of AI systems and seek to safely deploy them to the world through our products. AI is an extremely powerful tool that must be created with safety and human needs at its core, and to achieve our mission, we must encompass and value the many different perspectives, voices, and experiences that form the full spectrum of humanity.

XML job scraping automation by YubHub