Senior Manager, Biologics Process CMC; External

SUMMARY/JOB PURPOSE

The Senior Manager provides technical leadership and support across multiple CMC biologics areas to drive technology transfer, process validation, and manufacturing of biological drug candidates with a focus on Biologics including mAbs, Bi‑specifics and Antibody Drug Conjugates (ADCs). The Senior Manager utilizes their technical expertise in biologics process, biologics drug product, and / or bioconjugation process chemistry and process engineering to advance CMC development and manufacturing for in‑clinic biologics and bioconjugate molecules.

A strong technical focus is critical to ensure the speed, cost effectiveness and technical quality of our CMC activities. The individual works independently and in cross‑functional teams, leads and drives selected technical initiatives and CMC projects and works effectively with internal and third‑party CDMO partners. The individual has familiarity with analytics and formulation as they are working closely with these groups in addition to a general working knowledge of Biologics CMC.

• Apply technical knowledge and expertise in biologics process, biologics drug product, and / or bioconjugation, technology transfer and process validation to advance biological drug candidates across the product life cycle
• Support transfer, development and scale‑up of biologics process, biologics drug product, and / or bioconjugation from early‑stage CMC, into late‑stage CMC to enable clinical and commercial production
• Collaborate with internal and external partners in analytical and formulation groups to advance CMC biologics programs
• Deliver technical support to ensure successful clinical manufacturing, and to develop and implement process improvements as programs advance
• Lead and support various elements of phase appropriate CMC development activities, such as risk assessments, control strategy, and process validation
• Analyze, interpret, present and document complex technical information such as development data or manufacturing and testing trends, in support of CMC objectives
• Work with contract development manufacturing organizations (CDMOs) to help define project scope, review proposals, and oversee technical work
• Contribute to CMC regulatory strategies and submissions, and quality documentation
• Contribute to a broad range of technical objectives, such as troubleshooting urgent issues, proactive monitoring, and analysis of ongoing manufacturing/testing, and longer‑term development efforts.

• Supervises, hires, trains, provides work direction, and problem‑solving assistance for less experienced scientists. May directly oversee the daily operations of other staff
• May provide scientific direction to CDMO project teams to enable project progression

Education:

• Bachelor’s degree in chemistry, biochemistry, chemical engineering or related field and a minimum of nine years of relevant drug discovery/development experience; or,
• Master’s degree in chemistry, biochemistry, chemical engineering or related field and a minimum of seven years of relevant drug discovery/development experience; or,
• Ph.D. in chemistry, biochemistry, chemical engineering or related field and a minimum of two years of relevant drug discovery/development experience after completion of post‑doctoral training; or,
• Equivalent combination of education and experience.

Experience:

• Experience applying their technical knowledge to drive critical objectives for CMC biologics across the product life cycle
• Experience in bioprocess, biologics drug product, and / or bioconjugate process chemistry/purification with a working knowledge of CMC process development, technology transfer, and GMP quality requirements
• Demonstrated capability to work independently on complex technical problems, effectively in cross‑functional teams, and with external CDMOs and partners
• Experience planning, generating, analyzing, and linking experimental capabilities and results to critical CMC objectives

Knowledge/

Skills:

• Expertise in bioprocess, biologics drug product, and/ or bioconjugate process chemistry and purification
• Working knowledge…