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.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• 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.

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:

• 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 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

WORKING CONDITIONS:

• Environment: primarily working in office

• Exposures encountered, such as hazardous materials, extreme cold.

• Travel required ~5-10% of time

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