Director, MSAT Upstream Laboratory Lead

Role Summary

Lead the Gaithersburg MSAT Upstream Laboratory with scientific and strategic leadership. Collaborate with cross-functional teams to establish and run the MSAT Upstream Laboratory in global programs in close partnership with Process Development. Directly manage the Gaithersburg laboratory and develop phase-appropriate upstream scale-down models for antibody programs. Drive knowledge and technology transfers for antibody and ADC programs to enable upstream characterization, investigational and scale-down model studies, and support tech transfers and on-market support. Foster scientific rigor and continuous improvement and contribute to PPQ readiness and GMP compliance.

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

Qualifications

• Required: MS degree in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, or related discipline with 12+ years of pharmaceutical / biotechnology process development industry experience. PhD preferred.
• Preferred: PhD.
• Required: 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
• Required: Proven success leading cross-functional CMC teams and stakeholder/client management
• Required: Strong organizational, troubleshooting, and interpersonal skills along with excellent oral and written communication
• Required: Proven ability to design and perform complex projects while shaping scientific strategy both at the platform and program level
• Required: Proven ability to work independently, effectively plan and organize work activities and prioritize task completion to meet project deadlines
• Required: Demonstrated strategic & enterprise thinking
• Required: Experience as subject matter expert for antibody upstream processes.
• Required: Demonstrated collaboration with GMP Manufacturing, Quality Control, Quality Assurance, Engineering, Regulatory Affairs and Process Development within technology transfer projects and product commercialization.