In Operations, we turn molecules into medicine and are unified in our commitment to deliver more medicines to more patients more quickly. We are the critical link that brings innovation from our science labs to patients around the world.

We're achieving all of this while continuing to accelerate our operational excellence through innovative science, Lean ways of working, and evolving digital technologies.

Using cell therapy to halt and reverse disease, restore damaged organs, and, ultimately, cure many life-threatening conditions is now a realistic goal for our scientists and operators.

About Rockville Manufacturing Centre (RMC):

Our role in Operations is to bring these promising therapies from the lab to life through a thorough process of development, manufacturing, testing and supply.

Our fast-paced, growing environment provides a wealth of opportunity and global opportunities to learn from other teams, embrace lifelong learning and build capabilities, setting your own direction and pace for your long-term career.

Introduction to role:

Are you ready to develop an attitude of excellence? Join AstraZeneca's Operations team as the Quality Systems & Compliance Associate Director, Cell Therapy at the Rockville Manufacturing Centre (RMC) facility, the newest addition to our global supply network.

We aim to make a direct impact on patients by delivering life-saving cell therapies. This is your chance to break new ground and leave a collective legacy!

Accountabilities:

As the Quality Systems & Compliance Associate Director, Cell Therapy, you will provide leadership, direction and mentoring to ensure that the QS/C organisation is successful in meeting the quality and manufacturing objectives in support of site goals.

You will represent the QS/C department and/or the Quality Organisation on assigned site governance and operational teams internally, and as an empowered functional representative externally to ensure results are aligned with site business objectives.

You will facilitate the growth and development of QS/C staff, provide strategic support to the Quality Site Lead, Compliance and Site Support, for operational and long-term growth, and demonstrate excellent communication skills through internal and external channels.

Essential Skills/Experience:

• B.S. degree in Science, Engineering, Pharmacy, or related technical field with a minimum of 5 years of applicable experience

• Minimum of 2 years of management/supervisory/project management experience

• Experience in audit and inspection management

• Consistent record of working in a fast-paced, cross-functional work environment

• Excellent written and verbal communication skills

• Team oriented approach to project management and problem resolution

• Proven record of making decisions that balance patient safety, compliance, and supply

• Ability to influence senior collaborators, both internally and externally

• Ability to multi-task and prioritise work

Desirable Skills/Experience:

• M.S. degree in Science, Engineering, Pharmacy, or related technical field with a minimum of 5 years of applicable experience

• Advanced degree in Science, Engineering, Biochemistry, Pharmacy or related technical field

• Experience with Quality Systems (e.g. Veeva Vault) is desirable.

• Experience with Cell Therapy regulatory inspections

• Extensive working knowledge of international Cell Therapy GxP regulatory frameworks, regulations, and guidance.

• Experience engaging with global regulatory bodies

• Consistent track record of attracting and developing talent

Benefits:

AstraZeneca offers a competitive salary range of $129,556.80 - $194,335.20 USD Annual, 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.

At AstraZeneca, we champion a perspective of excellence. Our environment is driven by a belief that good can always be better. We continuously seek opportunities to contribute by harnessing science and evidence to foresee risks. It's a place where innovation thrives as we focus on delivering life-changing medicines to patients.

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The position shapes clinical drug supply strategy, converts it into actionable plans and drives consistent practices across studies and functions.

Acting as a key resource and escalation point, the role identifies and mitigates risks, ensures uninterrupted delivery of investigational medicinal product (IMP) to patients, and builds strong relationships across the organization.

Ready to influence how life-changing therapies reach clinical sites and patients?

Accountabilities:

• Develop and implement a comprehensive global supply chain strategy including robust contingency plans for investigational medicinal for radiopharmaceutical products.

• Ensure transparency with key stakeholders to ensure efficiency and delivery uninterrupted IMP to patients.

• Generate and maintain a clinical supply plan to drive manufacturing, labeling, and logistic activities across internal and external stakeholders.

• Create strong relationships with key stakeholders through collaboration with cross functional teams, including Global Study Team, CMC, manufacturing, and quality assurance to align supply chain activities.

• Design and implement processes and policies to enable inspection readiness for the management of clinical supply chain activities.

Implement systems or processes based on a fit for purpose model to ensure integrity and quality of IMP.

• Oversee the end-to-end supply chain process, from patient scheduling to IMP dosing/destruction in the conduct of a clinical trial ensuring compliance with all regulatory requirements and industry standards for the handling and transportation of IMP.

• Act as a conduit between functions pertaining to supply, transportation, logistics, and traceability issues for IMP.

• Be a part of a team to build a high-performing clinical supply chain team, providing mentorship and development opportunities.

Foster a culture of collaboration, innovation, and excellence within the team.

Mentor and teach junior supply chain as well as non-clinical supply chain team members.

• Ensure timely and accurate financial reporting and forecasting related to clinical supplies.

Essential Skills/Experience:

• Bachelor’s degree in supply chain management, Business Administration, Life Sciences, or a related field with 8+ years of experience in supply chain management, with at least 3 years in a leadership role within the pharmaceutical industry.

• IRT/XRS, Forecasting/Planning eSystems experience to design, implement and maintain systems used to automate clinical supply chain operations.

• Strong knowledge of regulatory requirements and industry standards for clinical supply chains.

• Excellent leadership, communication, negotiation skills, and the ability to work collaboratively with cross-functional teams.

• Flexible in working hours to deal with global time zones as needed.

• Must be willing to step in and perform all aspects of the clinical supply chain core functions when needed to ensure successfully support of patient dosing.

Have a sense of urgency and be comfortable pulling together stakeholders to make quick decisions as needed

Desirable Skills/Experience:

• Advanced degree preferred

• Certification in Supply Chain and Operations Management (i.e. – CSCP, CPIM) preferred

• Proven experience in cell therapy or radiopharmaceutical supply chain operations is a plus.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines.

In-person working gives us the platform we need to connect, work at pace and challenge perceptions.

That's why we work, on average, a minimum of three days per week from the office.

But that doesn't mean we're not flexible.

We balance the expectation of being in the office while respecting individual flexibility.

Join us in our unique and ambitious world.

AstraZeneca offers an environment where science leads the way: curiosity is encouraged, bold ideas are tested, and teams are empowered to push the boundaries of what is possible in oncology.

With significant ongoing investment in research and development, a strong track record of bringing new medicines to patients, and deep collaboration across internal experts and external partners, this is a place to shape the future of cancer treatment while building a meaningful career that has real impact on patients’ lives.

If this opportunity excites you and you are ready to help transform how innovative therapies reach patients in clinical trials, apply now!

The annual base pay for this position ranges from $115,919 to $173,879.

Our positions offer eligibility for various incentives,an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles.

Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans

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The role centers on novel target identification and validation for cell therapy discovery initiatives, underpinned by an in-depth understanding of cellular and molecular immunology, pathology of inflammation and immune disorders and/or expertise in CAR-T engineering.

Key responsibilities include: Demonstrating a comprehensive understanding of immunopathology at the cellular and molecular levels; multi-omics and bioinformatic data analysis; the landscape of known drug targets and therapeutics across modalities in clinical use; and emerging targets with investigational therapeutics in the field.

Partnering with cross-functional teams to initiate and drive discovery efforts focused on immune disorders, ensuring adherence to all relevant laws, regulations, and company policies related to the development and delivery of medicines.

Initiating cell therapy research,guided by curiosity, hypothesis, and data,to assess and validate novel targets, strategies, and approaches, enabling robust decision-making.

Essential skills and experience include: Advanced degree in Immunology, virology, innate and adaptive immune response, molecular or cell biology, bioengineering, or a related field; demonstrated proficiency in T- and B-cell culture and functional assays; multicolor flow cytometry (analysis and sorting); bioinformatics; in vivo disease models; and CRISPR and other genome-editing technologies.

Desirable experience includes a track record of peer-reviewed publications in prestigious immunological journals and/or patents.

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The Associate Director, Cell Therapy Logistics Coordinator Lead is the first-line operational lead and primary “go-to” for Logistics Coordinators (LCs) supporting autologous, allogeneic, and in vivo studies. As an individual contributor, you will oversee day-to-day execution across your assigned lanes/sites/programs, implement slot-management rules, balance and assign LC workload (including overtime/after-hours coverage), coach on best practices, and step in to perform LC tasks to maintain service levels.

Responsibilities:

• V2V execution and first-line support: Serve as operational point of contact for LCs; coordinate apheresis collections, manufacturing slot reservations, and temperature-controlled IMP/starting-material shipments; perform LC tasks to cover surge/backlog or critical paths.

• Slot management and scheduling: Implement established slot-management rules and guardrails; manage slot calendars and rescheduling across assigned studies/sites; align to manufacturing cycle/hold times and capacity; lead escalations to minimize patient impact.

• Shipment booking and exception management: Plan/oversee temperature-controlled bookings (LN2, 2–8 °C, ambient, OBC); coordinate pickups, customs clearance, and deliveries to meet release windows; monitor in-transit status; lead real-time recovery for delays, excursions, and holds with vendors and internal teams; ensure off-hours/overtime coverage.

• COI/COC and compliance: Ensure end-to-end COI/COC traceability and audit-ready documentation; support deviation investigations and implement CAPAs with Quality; uphold QMS/GxP/GDP.

• LC workload distribution and standards: Balance and assign shipments/patients/studies based on capacity/complexity; set day-to-day priorities; schedule overtime/after-hours coverage; reinforce SOPs/WIs/playbooks; deliver coaching and continuous feedback (no direct line management).

• Training and onboarding: Own onboarding plans for new LCs; provide recurring training on SOPs/WIs, systems, COI/COC controls, and exception playbooks; run shift handovers and huddles.

• Systems and data quality: Ensure timely/accurate milestones in cell orchestration/scheduling platforms and courier/LSP portals; lead UAT for enhancements; maintain user guides/work instructions; coach LCs on data quality standards.

• Reporting and analytics: Build and maintain operational KPIs (slot utilization, on-time pickup/delivery, cycle time, reschedule rate, excursion rate, deviation closure time); perform trend/RCA and drive corrective actions; provide concise readouts to study/leadership forums; partner with the separate analytics team for advanced modeling and capacity scenarios.

• Vendor and lane oversight (day-to-day): Manage shipment-level vendor issues and recoveries; coordinate contingencies/alternative routings; capture performance trends and incident summaries to inform the dedicated vendor management function and Quality/Procurement.

• Cross-functional coordination: Represent Logistics Operations in study/operational meetings; align with Global Planning/Manufacturing/Clinical/Depot Ops; support EU GDP handoffs and trade compliance with brokers and Legal/Compliance.

• Change readiness: Support logistics readiness for new indications, capabilities, facilities, and digital/process changes; lead hyper care for first-patient/first-site within assigned portfolio; train LCs on changes.

We are seeking a highly experienced professional with 8+ years in biopharma clinical logistics/supply chain with significant cell therapy V2V execution (COI/COC, cryogenic/refrigerated logistics, specialty couriers). Proven real-time problem-solving and shipment recovery; shift/coverage leadership.

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Responsibilities:

• Perform tasks in a manner consistent with safety policies, quality systems, and cGMP requirements.
• Assist in the development of Standard Operating Procedures (SOPs) for manufacturing processes.
• Assist in setting up manufacturing areas and equipment, including complex automated cell processing equipment.
• Follow all cleaning and gowning procedures for the facility.
• Maintain appropriate inventories of material and supplies within the cleanroom areas to support manufacturing activities.
• Ensure all materials and equipment are identified and available in time for manufacturing activities.
• Support Process Development and MSAT to align manufacturing plans with overall product development plans.
• Ensure that all production operations are controlled and executed within cGMP regulatory guidelines.
• Provide timely verbal and written updates to Manufacturing leadership.
• Support all new product/process introductions on site.
• Interact with vendors and outside resources.
• Complete assigned projects.
• Be the shift lead if required, providing instruction to the team.
• Troubleshoot and resolve operational problems during processing.
• Represent Manufacturing in cross-functional initiatives and meetings.
• Monitor and evaluate process trends and recommend and implement continuous improvement strategies as appropriate.
• Manage multiple projects independently.
• Plan and implement complex changes.
• Perform Environmental monitoring as required.
• Technical expert for entire area(s).
• Interact independently with regulatory agencies.
• Develop and provide training on complex manufacturing processes.
• Perform Manufacturing review and approval of critical documents.
• Develop process validation protocols.
• Maintain good housekeeping and clean and sanitize classified areas as required.
• Analyze complex problems and determine and implement solutions.
• Other duties and projects assigned to meet business needs.

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This position is essential for ensuring that the laboratory meets the high standards required for CGMP Quality Control Operations. The candidate will be primarily responsible for the receipt, storage, inventory, and distribution and preparation of samples, controls, reagents and standards used in analytical testing, utilizing paper and computer-based inventory systems.

The candidate will also be responsible for the operation, organization and maintenance of Temperature-Controlled Storage Units and ensure that samples, reagents, standards and controls are stored in appropriate temperature conditions utilizing paper and computer-based asset systems.

The candidate will support the calibration and maintenance activities required for QC equipment using computerised asset management software.

The candidate will complete and document activities in accordance with CGMPs, SOPs, and protocols.

Perform compendial assays and processing of samples as needed.

Report deviation events to QC management.

This position is essential for ensuring that the laboratory meets the high standards required for CGMP lot release and stability testing.

The role also involves contributing to the writing and revision of Standard Operating Procedures (SOPs) and other CGMP documentation.

The position requires a strong background in laboratory practices, general testing methodology, assay troubleshooting, and familiarity with Quality Systems.

Perform other duties as assigned.

Ability to follow safety procedures outlined in the Safety, Health and Environmental requirements.

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Training on natural and experimentally-derived data is a core aspect of how our AI models learn to generate therapeutic molecules with exceptional properties. We invest deeply in building and scaling data sources to train and evaluate our models for maximal performance. At the same time, careful validation in orthogonal, translationally-relevant assays is crucial to orient our models.

We are seeking a senior scientific leader versed in high-throughput and translational biology to drive the continued growth and impact of our Palo Alto Lab. You will be a force multiplier for our scientists and engineers, ensuring a high standard of scientific rigor and output in a fast-paced, dynamic environment. You will also interface closely with our AI team to maximize the impact of internal data on Inceptive’s foundation models.

Your Mission, should you choose to accept it - Lead development and scale-up of high-throughput assays across in vitro, cellular, and in vivo systems, leveraging multiplexed assays and laboratory automation - Define and execute a lab strategy aligned with Inceptive’s therapeutic and platform priorities, while remaining flexible as modality and partnership needs evolve - Champion an interdisciplinary culture, encouraging curiosity, rigor, and collaboration across scientific boundaries - Manage, mentor, and develop a multidisciplinary team of scientists and engineers that rapidly generates high-impact biological data to improve and validate AI design models - Oversee the development of industry-standard validation assays to keep models and data generation aligned with downstream therapeutic application

Qualifications - PhD and 6+ years of post-PhD experience in industrial research applied to drug development - Experience managing and mentoring a data-driven lab of 10+ scientists - Experience using high-throughput and/or highly multiplexed assays to generate rich datasets from mammalian cells - Proven ability to set scientific direction while also executing operationally - Deep understanding of theory, techniques, and experimental design in molecular and cellular biology - Visualization, analysis, and statistics applied to complex biological datasets - Availability to work with team members across US and Europe, with meetings starting at 7am PT - Readiness to travel several times a year for company retreats and business events - We value in-person collaboration and expect candidates to work at our lab location

Preferred skills - Translational experience with mRNA, oligonucleotides, or other genetic medicines - Expertise in immunology and/or cell therapy - Hands-on experience in RNA biology and biochemistry - Scientific programming in Python - Hands-on experience with modern data engineering workflows

Compensation $245K – $305K + Bonus + Equity

What we offer - A competitive compensation package - 30 days paid vacation per year - Comprehensive health insurance for US based Beginners - 401K with company match for US based Beginners and Direktversicherung for German Beginners - Quarterly company-wide retreats - Monthly wellness benefit - Budget for multiple visits per year to our offices in Berlin, Palo Alto or Switzerland - Learning & Development budget to attend conferences, take courses, or otherwise invest in your professional growth, as well as access to the Learning & Development platform EdX and Hone - A buddy to help you get settled *Varies by country and does not apply to internships

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