You will work with sending out samples/registration samples and support the storage of samples for stability testing as well as handling complaints.

To be successful in this role, you will need to have a strong understanding of pharmaceutical production and regulations, as well as experience working in a GMP environment. You should also be familiar with standard software such as Word, Excel, and Teams.

Our team is committed to providing a supportive and inclusive work environment, where you can bring your whole self to work. We offer a competitive salary and benefits package, as well as opportunities for professional development and growth.

If you are curious, motivated, and passionate about making a difference in the world, we encourage you to apply for this exciting opportunity.

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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

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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.

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