Director, MS&T Downstream Laboratory Lead

Role Summary

Director, MS&T Downstream Laboratory Lead, Gaithersburg, US. This role provides scientific and strategic leadership for the Gaithersburg MSAT Downstream Laboratory, collaborates with cross-functional teams to establish and run the downstream MSAT laboratory in support of global programs, and leads hands-on management of the laboratory. The role develops phase-appropriate downstream scale-down models for antibody programs, supports technology transfers and on-market support, and drives scientific rigor and continuous improvement in downstream processes.

Responsibilities

• Provide scientific and strategic leadership for the Gaithersburg MSAT Downstream Laboratory
• Collaborate with teams across Supply Chain, Process Development, AS&T, Analytical Development, Quality, and Regulatory to establish and run the downstream MSAT laboratory in support of global programs
• 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 a critical leadership role in designing, developing, characterizing, and qualifying downstream processes (including chromatography, filtration, viral inactivation and filtration, UFDF concentration, formulation, and cryopreservation)
• Draft SOPs, reports, and presentations
• Maintain and troubleshoot instrumentation and equipment
• Collaborate with internal 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, 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

Qualifications

• Required: MS degree in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, or related discipline with 12 plus years of pharmaceutical/biotechnology process development industry experience
• 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 and enterprise thinking
• Required: Experience as subject matter expert for antibody downstream processes
• Required: Demonstrated collaboration with GMP Manufacturing, Quality Control, Quality Assurance, Engineering, Regulatory Affairs and Process Development within technology transfer projects and product commercialization
• Preferred: PhD