Associate Director, Manufacturing Science and Technology

Summary

Join Apogee Therapeutics, a Nasdaq-listed biotechnology company, as an MSAT Associate Director. Reporting to the MSAT Director, you will collaborate with CDMOs to execute late-stage development and commercialization of monoclonal antibody Drug Substance (DS). This role involves tech transfer, troubleshooting, deviation resolution, and campaign analysis. You will develop and deliver product understanding and control strategies, author technical reports, and work closely with CDMO partners. The position requires significant experience in biologics development and manufacturing, expertise in upstream or downstream processes, and strong communication skills. Apogee offers a competitive compensation and benefits package, including flexible PTO and opportunities for professional development.

Requirements

• 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
• 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

Responsibilities

• 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

Benefits

• A great culture, grounded in our C.O.R.E. values: C aring, O riginal, R esilient and E goless
• Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly
• Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
• Flexible PTO
• Two, one-week company-wide shutdowns each year
• Commitment to growing you professionally and providing access to resources to further your development
• Apogee offers regular all team, in-person meetings to build relationships and problem solve