Senior Manager, Biologics Process

SUMMARY/JOB PURPOSE:

The Senior Manager provides technical leadership and support across multiple CMC biologics areas to drive late-stage process development, technology transfer, Process characterization, 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 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.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Apply technical knowledge and expertise in biologics process and / or bioconjugation, late-stage process development and technology transfer, process characterization and process validation to advance biological drug candidates across the product life cycle
• Support transfer, development and scale-up of biologics process and / or bioconjugation from early-stage CMC , into late-stage CMC to enable late stage 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 late-stage CMC development activities, such as risk assessments, process characterization, 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.

SUPERVISORY RESPONSIBILITIES:

• 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/EXPERIENCE/KNOWLEDGE & SKILLS:

Education/Experience:

• 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/The Ideal for Successful Entry into Job:

• Experience applying their technical knowledge to drive critical objectives for CMC biologics across the product life cycle
• Experience in late-stage bioprocess 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 and/ or bioconjugate process chemistry and purification
• Working knowledge of biologics and/ or bioconjugate analytics and formulation
• Ability to apply technical knowledge to CMC development and manufacturing for biologics across the product life cycle
• Ability to collaborate with and lead effectively cross-functionally and in a team setting, both internally and with external CDMOs and partners
• Ability to multi-task in a fast-paced dynamic environment while delivering high quality work
• Strong understanding of cGMP quality and regulatory requirements for CMC biologics
• Sets goals with understanding of priority and impact to the program, department, and organization
• Excellent interpersonal, presentation, and written communication skills
• Creative thinker and complex problem solver

JOB COMPLEXITY:

WORKING CONDITIONS:

• Environment: primarily working in office
• Exposures encountered, such as hazardous materials, extreme cold.
• Travel required ~10-20% of time

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