CMC Director

ClinLab Solutions Group; Boston (MA); On-site; USD 180,000 - 260,000; Full time

Job summary

ClinLab Solutions Group is seeking an Associate Director/Director, CMC (Late Stage Development, Bioprocess) to provide technical and operational leadership for monoclonal antibody development and manufacturing, focusing on late-stage CMC strategies and external partnerships.

The role requires deep bioprocessing expertise, cross-functional leadership, and ability to translate process understanding into robust control strategies, PPQ readiness, and CPV transition.

Qualifications

• Bachelor’s, Master’s, or Ph.D. in chemical or biochemical engineering, biotechnology, biochemistry, pharmaceutical sciences, or a related discipline.
• 10+ years of progressively responsible experience in biologics process development/technical operations, with upstream or downstream focus and/or MSAT.
• Deep expertise in upstream or downstream bioprocess development and/or MSAT, with breadth to work across analytical, formulation, and drug product.
• Direct late-stage experience supporting process characterization, technology transfer, PPQ readiness or execution, and CPV for a biologic program.
• Demonstrated experience overseeing external manufacturing organizations and GMP manufacturing activities, including technical documentation, issue resolution, and risk management.
• Strong working knowledge of QbD, DoE, process validation lifecycle principles, control strategies, quality risk management, and applicable FDA/EMA/ICH expectations.
• Strong scientific judgment, technical writing, communication, organizational skills, detail orientation, and proven ability to lead cross-functional work and influence without direct authority.
• Collaborative, proactive, highly organized, detail-oriented, and able to communicate with clarity and respect across teams.

Responsibilities

• Lead CMC strategy and execution for assigned programs, integrating process, analytical, manufacturing, quality, regulatory, supply, timeline, and budget considerations.
• Provide technical leadership for upstream and/or downstream process development, scale-up/scale-down models, technology transfer, process characterization, and GMP manufacturing of monoclonal antibodies.
• Drive late-stage process development, process characterization, and validation strategies through PPQ, including study design and process definition.
• Act as the primary technical interface with external manufacturing organizations, overseeing plans, protocols, batch records, reports, and campaign readiness.
• Review manufacturing and product-quality data to identify trends and risks; lead or support investigations, root-cause analysis, CAPAs, change controls, and technical issue resolution.
• Translate process understanding into robust control strategies, including CQAs, CPPs, operating ranges, sampling plans, and statistical approaches.
• Drive PPQ readiness and execution, author/review supporting plans, risk assessments, protocols, and reports, ensuring effective transition into continued process verification (CPV).
• Collaborate with regulatory teams to author and review manufacturing and process sections of regulatory submissions, amendments, and responses to health authority questions.

Skills

CMC Strategy

Bioprocess Development

Tech Transfer

GMP Manufacturing

PPQ Readiness

QbD & DoE

Regulatory Submissions

Risk Management

Cross-functional Leadership

Process Characterization

Education

Bachelor/Master/PhD in chemical/biochemical engineering, biotechnology, biochemistry, pharmaceutical sciences

Job description

Associate Director/Director, CMC (Late Stage Development, Bioprocess)

Summary:

Seeking an experienced professional to provide technical and operational leadership for monoclonal antibody development and manufacturing, focusing on late-stage CMC strategies, process development, and external manufacturing. This role requires expertise in bioprocessing and the ability to integrate across multiple CMC functions, lead workstreams, and serve as a technical interface with external partners.

Responsibilities:

• Lead CMC strategy and execution for assigned programs, integrating process, analytical, manufacturing, quality, regulatory, supply, timeline, and budget considerations.
• Provide technical leadership for upstream and/or downstream process development, scale-up/scale-down models, technology transfer, process characterization, and GMP manufacturing of monoclonal antibodies.
• Drive late-stage process development, process characterization, and validation strategies through PPQ, including study design and process definition.
• Act as the primary technical interface with external manufacturing organizations, overseeing plans, protocols, batch records, reports, and campaign readiness.
• Review manufacturing and product-quality data to identify trends and risks; lead or support investigations, root-cause analysis, CAPAs, change controls, and technical issue resolution.
• Translate process understanding into robust control strategies, including CQAs, CPPs, operating ranges, sampling plans, and statistical approaches.
• Drive PPQ readiness and execution, author/review supporting plans, risk assessments, protocols, and reports, ensuring effective transition into continued process verification (CPV).
• Collaborate with regulatory teams to author and review manufacturing and process sections of regulatory submissions, amendments, and responses to health authority questions.

Qualifications:

• Bachelor’s, Master’s, or Ph.D. in chemical or biochemical engineering, biotechnology, biochemistry, pharmaceutical sciences, or a related discipline.
• 10+ years of progressively responsible experience in biologics process development/technical operations, with upstream or downstream focus and/or MSAT.
• Deep expertise in upstream or downstream bioprocess development and/or MSAT, with breadth to work across analytical, formulation, and drug product.
• Direct late-stage experience supporting process characterization, technology transfer, PPQ readiness or execution, and CPV for a biologic program.
• Demonstrated experience overseeing external manufacturing organizations and GMP manufacturing activities, including technical documentation, issue resolution, and risk management.
• Strong working knowledge of QbD, DoE, process validation lifecycle principles, control strategies, quality risk management, and applicable FDA/EMA/ICH expectations.
• Strong scientific judgment, technical writing, communication, organizational skills, detail orientation, and proven ability to lead cross-functional work and influence without direct authority.
• Collaborative, proactive, highly organized, detail-oriented, and able to communicate with clarity and respect across teams.
• Comfortable moving between strategy and hands-on execution, and able to contribute beyond primary specialty as priorities shift.