Provide scientific and strategic leadership for the Gaithersburg MSAT Downstream Laboratory
Collaborate across teams (Supply Chain, Process Development, AS&T, Analytical Development, Quality, Regulatory) to establish and run upstream MSAT laboratory operations
Develop phase-appropriate downstream scale-down models for antibody programs
Lead knowledge and technology transfers for antibody and ADC programs to enable downstream characterization, investigational studies, and scale-down model execution
Coach and develop MSAT team members on downstream antibody manufacturing processes and foster a culture of scientific rigor and continuous improvement
Draft SOPs, reports, presentations; maintain instrumentation/equipment; troubleshoot issues as needed
Collaborate with internal teams and external groups to advance late-stage antibody capabilities
Contribute to PPQ protocol authoring/review ensuring GMP compliance and scientific rigor

Master's degree in Biochemical Engineering, Chemical Engineering, Biomedical Engineering or related discipline
12+ years of pharmaceutical/biotechnology process development industry experience
In-depth CMC knowledge in early or late-stage antibody technology transfer projects
Proven success leading cross-functional CMC teams
Strong organizational skills and stakeholder/client management expertise
Experience as subject matter expert for antibody downstream processes including technology transfer projects/product commercialization
Demonstrated ability to design complex projects while shaping scientific strategy

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, MS&T Downstream Laboratory Lead

Key skills