Associate Director, Manufacturing Science and Technology

We are seeking a dynamic and experienced MSAT Associate Director to join the Development, Manufacturing, and Supply (DMS) team.  Reporting to the MSAT Director, this role will be responsible for working with CDMO(s) to execute late-stage development through launch/commercialization activities, enabling robust production of monoclonal antibody Drug Substance (DS). This interdisciplinary position will provide stewardship of cell culture and/or purification, including scale-up from lab to manufacturing scale. Support of manufacturing campaigns will be critical, including tech transfer, troubleshooting, deviation resolution, and campaign analysis activities.  

Key Responsibilities

In collaboration with the MSAT Director and the broader DMS team, this individual in this role will:

• Develop and deliver phase-appropriate product understanding and control strategies using QbD framework and risk assessments
• Support manufacture of clinical and commercial GMP DS throughout product lifecycle, including tech transfer, campaign analysis, and diagnostics
• Author and review technical reports, master and executed batch records, working across internal team and with CDMO partners.
• Author and review internal procedures, reports, and presentations, as needed.
• Work closely with CDMO partners, providing technical oversight and taking the lead in supporting investigations and resolving deviations.
• Analyze process and manufacturing data to understand and optimize process performance
• Develop process characterization and PPQ strategies and documentation
• Support regulatory activities including submissions and site inspections from preparation through execution
• Liaise with DP and device development as needed to ensure seamless end to end product delivery and robustness
• Develop and maintain cost of good models that describe process and enable sensitivity analyses for process improvements
• Collaborate closely with colleagues to ensure a seamless, highly integrated TechOps team

Ideal Candidate

• BS, MS, PhD in relevant discipline (e.g., biology, biochemistry, biochemical engineering, or relevant field) or commensurate years of education and experience
• 8+ years biologics development and manufacturing experience
• Expertise in either upstream or downstream tech transfer, process characterization, and commercialization
  • Experience with late phase development and commercialization of biologics within most of the relevant process areas (upstream cell culture, downstream processing, solution prep, cleaning, automation, data systems, etc.)
  • Experience with tech transfer to CDMOs and supporting DS campaigns through scale up and validation
  • Experience with design, execution, and analysis of process characterization studies
  • Experience with process and economic modeling of DS manufacturing processes
• Demonstrated aptitude in collaborating with cross-functional partners, including clinical development/operations, analytical development, QA, RA, and supply chain.
• Excellent communication skills with an ability to present to a variety of stakeholders and tailor message accordingly
• Demonstrated growth mindset, willing to learn from others, and dedication to promoting a psychologically safe environment

Other Requirements

• Ability and willingness to travel up to 20% including to CDMOs
• Ability to multi-task and keep pace with a fast-moving organization
• Availability to participate in calls across multiple international time zones

The anticipated salary range for candidates for this role will be $160,000 - $185,000/ year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.