Director, MSAT Upstream Laboratory Lead

BioNTech•Gaithersburg, MD

About The Position

Provide scientific and strategic leadership for the Gaithersburg MSAT Upstream Laboratory Collaborate with various teams (Supply Chain, Process Development, AS&T, Analytical Development, Quality, Regulatory) to establish and run the MSAT Upstream Laboratory in support of global programs in close partnership with process development Provide direct hands-on management of the Gaithersburg MSAT Upstream Laboratory Develop phase appropriate upstream scale down models for antibody programs Participate in knowledge and technology transfers for antibody and ADC programs to enable design and execution of upstream characterization, investigational and scale-down model studies to support tech transfers and on market support Coach and develop MSAT team members on upstream 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 upstream processes (includes cell processing, culture and expansion, harvest, 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 upstream tech transfer teams and the Process Validation team to ensure PPQ readiness; contribute to PPQ protocol and report 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. PhD preferred.
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 upstream 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
Experience with antibody or ADC on market technical support is considered a plus

Responsibilities

Provide scientific and strategic leadership for the Gaithersburg MSAT Upstream Laboratory
Collaborate with various teams (Supply Chain, Process Development, AS&T, Analytical Development, Quality, Regulatory) to establish and run the MSAT Upstream Laboratory in support of global programs in close partnership with process development
Provide direct hands-on management of the Gaithersburg MSAT Upstream Laboratory
Develop phase appropriate upstream scale down models for antibody programs
Participate in knowledge and technology transfers for antibody and ADC programs to enable design and execution of upstream characterization, investigational and scale-down model studies to support tech transfers and on market support
Coach and develop MSAT team members on upstream 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 upstream processes (includes cell processing, culture and expansion, harvest, 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 upstream tech transfer teams and the Process Validation team to ensure PPQ readiness; contribute to PPQ protocol and report authoring and review ensuring GMP compliance and scientific rigor