Senior Manager, Biologics Process CMC (External)
Location: United States | Full-Time | Onsite/Hybrid (Depending on Business Needs)
Position Overview
The Senior Manager, Biologics Process CMC, provides strategic technical leadership across core biologics development areas including technology transfer, process validation, scale-up, and clinical manufacturing. This role supports the end-to-end CMC activities for biologics programs such as monoclonal antibodies (mAbs), bi-specific antibodies, and antibody–drug conjugates (ADCs). The position requires deep expertise in biologics process development, drug product manufacturing, and bioconjugation chemistry, with the ability to independently execute technical projects and collaborate with internal teams and external CDMOs.
The ideal candidate ensures high technical quality, operational efficiency, and phase-appropriate CMC progression for in-clinic biologics and bioconjugate programs.
Key Responsibilities
Apply expert-level knowledge in biologics process development, biologics drug product, and bioconjugation to support the full CMC lifecycle.
Lead technology transfer, scale-up, and process validation activities from early-stage to late-stage development.
Collaborate with analytical and formulation teams to advance biologics CMC strategies.
Provide technical oversight for clinical manufacturing and identify opportunities for continuous process improvement.
Lead risk assessments, develop control strategies, and support process validation deliverables.
Analyze, interpret, and document technical data including development studies and manufacturing trends.
Partner with CDMOs to define project scope, evaluate proposals, and oversee execution of technical activities.
Support regulatory submissions by contributing to CMC documentation and technical content.
Troubleshoot complex technical challenges and proactively monitor ongoing manufacturing and testing operations.
Drive longer-term development strategies aligned with program goals.
Supervisory Responsibilities
Supervise, hire, and train junior scientists.
Provide daily direction and performance support for less-experienced team members.
Offer scientific guidance to CDMO project teams to ensure successful program execution.
Education & Experience Requirements
Education (One of the following is required):
Bachelor’s degree in chemistry, biochemistry, chemical engineering, or related field with minimum 9 years of relevant drug discovery/development experience; or
Master’s degree in related scientific fields with minimum 7 years of relevant experience; or
Ph.D. in chemistry, biochemistry, chemical engineering, or related field with minimum 2 years of post-doctoral industry experience; or
Equivalent combination of education and experience.
Required Experience
Demonstrated expertise supporting CMC biologics programs across early to late development stages.
Hands-on experience in bioprocess development, biologics drug product, and/or bioconjugate chemistry and purification.
Strong understanding of CMC development frameworks, technology transfer, and cGMP requirements.
Proven ability to work independently on complex technical challenges and collaborate with cross-functional teams and CDMOs.
Experience generating, analyzing, and correlating experimental data to critical CMC objectives.
Skills & Competencies
Advanced technical knowledge in biologics process engineering, drug product development, and bioconjugation.
Working knowledge of biologics analytics and formulation principles.
Strong cross-functional leadership and collaboration capabilities.
Ability to manage multiple priorities in a dynamic, fast-paced environment.
Deep understanding of cGMP and regulatory expectations for biologics CMC.
Exceptional communication skills, including presentation and scientific writing.
Ability to set strategic goals with an understanding of program impact.
Strong problem-solving skills and innovative thinking.
Working Conditions
Primarily office-based environment.
Occasional exposure to laboratory materials or temperature-controlled areas.
Travel requirement: 5–10%, including domestic travel to CDMOs or partner sites.
Compensation & Benefits
Compensation is aligned with U.S. geographic labor markets.
Base Salary Range: USD 165,500 – 235,500 annually, adjusted based on work location, experience, and internal equity.
Total Rewards Package Includes:
Comprehensive medical, dental, and vision coverage
401(k) plan with competitive employer contributions
Life and disability insurance
Flexible spending accounts
Annual discretionary bonus eligibility
Employee stock purchase plan and long-term incentive opportunities
15 vacation days in the first year
17 paid company holidays, including a winter shutdown
Up to 10 annual sick days
Disclaimer
This job description highlights the general scope, responsibilities, and qualifications of the role. It is not intended to be an exhaustive list of duties or expectations and may evolve based on organizational needs.
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