Provide scientific and strategic leadership for the Gaithersburg MSAT Upstream Laboratory
Collaborate across teams (Supply Chain, Process Development, AS&T, Analytical Development, Quality, Regulatory) to establish and run the MSAT Upstream Laboratory operations
Develop phase-appropriate upstream scale-down models for antibody programs
Lead knowledge and technology transfers for antibody and ADC programs
Coach and develop MSAT team members on upstream antibody manufacturing processes
Design, develop, characterize, qualify upstream processes including cell processing, culture/expansion, harvest, cryopreservation
Draft SOPs, reports, presentations; maintain instrumentation/equipment; troubleshoot issues
Collaborate with internal teams and external groups to advance late-stage antibody capabilities
Contribute to PPQ protocol/report authoring ensuring GMP compliance and scientific rigor

Master's degree in Biochemical Engineering, Chemical Engineering, Biomedical Engineering or related discipline
12 plus years of pharmaceutical/biotechnology process development industry experience
In-depth CMC knowledge in early or late-stage antibody technology transfer projects
Sound understanding of all stages of antibody drug development (GMP/QbD approach)
Proven success leading cross-functional CMC teams
Strong organizational skills and stakeholder/client management expertise
Experience as subject matter expert for antibody upstream processes
Experience with technology transfer projects/product commercialization
Demonstrated ability to design complex projects while shaping scientific strategy
Strong collaboration skills across GMP Manufacturing, Quality Control/Assurance teams

Medical, Dental and Vision Insurance
Life, AD&D, Critical Illness Insurance
Pre-tax HSA & FSA, DCRA Spending Accounts
Employee Assistance & Concierge Program (EAP) available 24/7
Parental and Childbirth Leave & Family Planning Assistance
Sitterstream: Virtual Tutoring & Childcare Membership
Paid Time Off: Vacation, Sick, Bereavement, Holidays (including Floating) & Year-End U.S. Shutdown.
401(K) Plan with Company Match
Tuition Reimbursement & Student Loan Assistance Programs
Wellbeing Incentive Platforms & Incentives
Professional Development Programs
Commuting Allowance and subsidized parking
Discounted Home, Auto & Pet Insurance
…and more!

Director, MSAT Upstream Laboratory Lead

Key skills