MSAT Director Drug Product

Summit Therapeutics Sub; England; On-site; GBP 74,000 - 90,000; Full time

Job summary

A leading biopharmaceutical company seeking a Director of MSAT - Drug Product to lead process development and validation for sterile drug products. This role involves managing a team, collaborating with CMC teams, and ensuring compliance with regulatory expectations. Ideal candidates should have extensive experience (10+ years) in biologics manufacturing and a strong track record in regulatory submissions. A competitive salary range of $100,000.00 – $120,000.00 annually is offered, alongside potential bonuses and other benefits.

Qualifications

• 10+ years of experience in biologics manufacturing focusing on sterile drug products.
• Proven track record in BLA preparation and commercial launch.
• Strong knowledge of FDA and EMA regulatory expectations.

Responsibilities

• Lead process development and validation for sterile drug products.
• Collaborate with CMC teams to ensure successful execution of manufacturing.
• Manage communication with regulatory agencies.

Skills

Experience in biologics manufacturing

Expertise in sterile drug product operations

Strong project management skills

Leadership skills

Knowledge of regulatory expectations

Education

MSc in Engineering, Biochemistry, Pharmaceutical Sciences or related field

PhD preferred

Job description

Overview of Role

We are seeking a highly experienced and strategic Director of MSAT - Drug Product to join the CMC team and lead ongoing process development, technology transfer, process validation, BLA/IND/IMPD authoring and readiness, and agency interaction activities in preparation for commercialization and incremental clinical/commercial batch production of our main asset. This role will focus on leading a small DP team, technology transfer(s), and co-authoring the CMC chapters of regulatory submissions, ensuring all required data integrity and technical compliance standards are met. The ideal candidate will bring deep expertise in biologics manufacturing, sterile drug product operations and regulatory expectations. This role will also contribute strategically and technically to future improvements, scale‑up / scale‑out decisions, etc.

Role and Responsibilities

• Lead process development/characterization tech transfer and process validation for sterile drug product, including oversight of external CDMOs and internal teams.
• Partner with the broader CMC team to implement process, product and site changes.
• Support the team’s successful execution of clinical and commercial batch manufacturing in alignment with development and supply timelines.
• Be accountable with the team to successfully deliver CMC chapters to regulatory documents.
• Actively support dialogue/interaction with regulatory agencies.
• Support PLI/PAI preparation and delivery.
• Responsible for all stages of Process Validation, including CPV (Continuous Process Verification), in accordance with governing quality system requirements.
• Prioritize post‑approval opportunities and develop business cases for further investment/development.
• Foster effective communication and collaboration with internal and external stakeholders, including other CMC functions, Regulatory Affairs, Quality Assurance and CROs/CDMOs.
• Collaboratively work across the broader CMC regulatory and quality departments to deliver desired outcomes.
• Collaborate cross‑functionally with Regulatory, Quality, Supply Chain and CMC teams to ensure integrated planning and execution.
• Ensure GMP compliance across all activities.
• Support audits and inspections.
• All other duties as assigned.

Experience, Education and Specialized Knowledge and Skills

• MSc degree in Engineering, Biochemistry, Pharmaceutical Sciences or related field; PhD preferred.
• Minimum of 10 years of experience in biologics manufacturing with a focus on sterile drug product and late‑phase development.
• Proven track record in BLA preparation, PPQ and commercial launch.
• Strong knowledge of regulatory expectations (FDA, EMA) for biologics and sterile drug product(s).
• Strong team‑player and promoter of inclusion and collaboration.
• Able to handle multiple projects simultaneously while maintaining high‑quality results.
• Capable of providing and implementing innovative solutions to unique and pressing situations.
• Experience managing CDMO partners and internal cross‑functional teams.
• Excellent leadership, communication and project management skills.

The pay range for this role is $100,000.00 – $120,000.00 annually. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may differ in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock benefits and/or other applicable variable compensation.

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