Director, MS&T Downstream Laboratory Lead

BioNTech•Gaithersburg, MD

About The Position

Provide scientific and strategic leadership for the Gaithersburg MSAT Downstream Laboratory Collaborate with various teams (Supply Chain, Process Development, AS&T, Analytical Development, Quality, Regulatory) to establish and run the upstream MSAT laboratory in support of global programs in close partnership with process development Provide direct hands-on management of the Gaithersburg MSAT Downstream Laboratory. Develop phase appropriate downstream scale down models for antibody programs Participate in knowledge and technology transfers for antibody and ADC programs to enable design and execution of downstream characterization, investigational and scale-down model studies to support tech transfers and on market support. Coach and develop MSAT team members on downstream antibody manufacturing processes, laboratory activities and studies. Foster a culture of scientific rigor, Innovation and continuous improvement. Play critical leadership role in designing, developing, characterizing, and qualifying downstream processes (includes chromatography, filtration, viral inactivation and filtration, UFDF concentration, formulation and and cryopreservation) Draft SOPs, reports, and presentations Maintain and troubleshoot instrumentation and equipment. Collaborate with both internal teams and external groups to advance late-stage antibody capabilities Support data analysis and present results within the team and to broader scientific groups Maintain a high standard of good documentation practice, experimentation and record keeping Work productively in a team environment and independently to deliver against timelines Lead projects, CAPAs and deviations/ investigations and/ or continuous improvement efforts Support technology transfer to GMP from contract manufacturers or the internal process development team, including process/facility gap assessments and drafting/reviewing GMP documents (batch records, tech transfer protocols, sampling plans) Collaborate closely with downstream tech transfer teams and the Process Validation team to ensure PPQ readiness; contribute to PPQ protocol authoring and review ensuring GMP compliance and scientific rigor

Requirements

MS degree in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, or related discipline with 12 plus years of pharmaceutical / biotechnology process development industry experience.
In-depth CMC knowledge in either early or late-stage antibody technology transfer projects with sound understanding of all stages of antibody drug development, GMP, and QbD approach
Experience with antibody or ADC on market technical support is considered a plus
Proven success leading cross-functional CMC teams and stakeholder/client management
Strong organizational, troubleshooting, and interpersonal skills along with excellent oral and written communication
Proven ability to design and perform complex projects while shaping scientific strategy both at the platform and program level
Proven ability to work independently, effectively plan and organize work activities and prioritize task completion to meet project deadlines
Demonstrated strategic & enterprise thinking
Experience as subject matter expert for antibody downstream processes
Demonstrated collaboration with GMP Manufacturing, Quality Control, Quality Assurance, Engineering, Regulatory Affairs and Process Development within technology transfer projects and product commercialization

Nice To Haves

PhD
US based candidates expected

Responsibilities

Provide scientific and strategic leadership for the Gaithersburg MSAT Downstream Laboratory
Collaborate with various teams (Supply Chain, Process Development, AS&T, Analytical Development, Quality, Regulatory) to establish and run the upstream MSAT laboratory in support of global programs in close partnership with process development
Provide direct hands-on management of the Gaithersburg MSAT Downstream Laboratory.
Develop phase appropriate downstream scale down models for antibody programs
Participate in knowledge and technology transfers for antibody and ADC programs to enable design and execution of downstream characterization, investigational and scale-down model studies to support tech transfers and on market support.
Coach and develop MSAT team members on downstream antibody manufacturing processes, laboratory activities and studies.
Foster a culture of scientific rigor, Innovation and continuous improvement.
Play critical leadership role in designing, developing, characterizing, and qualifying downstream processes (includes chromatography, filtration, viral inactivation and filtration, UFDF concentration, formulation and and cryopreservation)
Draft SOPs, reports, and presentations
Maintain and troubleshoot instrumentation and equipment.
Collaborate with both internal teams and external groups to advance late-stage antibody capabilities
Support data analysis and present results within the team and to broader scientific groups
Maintain a high standard of good documentation practice, experimentation and record keeping
Work productively in a team environment and independently to deliver against timelines
Lead projects, CAPAs and deviations/ investigations and/ or continuous improvement efforts
Support technology transfer to GMP from contract manufacturers or the internal process development team, including process/facility gap assessments and drafting/reviewing GMP documents (batch records, tech transfer protocols, sampling plans)
Collaborate closely with downstream tech transfer teams and the Process Validation team to ensure PPQ readiness; contribute to PPQ protocol authoring and review ensuring GMP compliance and scientific rigor

Benefits

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