Hiring: Associate Director/Director, CMC Company: ClinLab Solutions Group Location: Boston, MA Job Posted Time: 2026-09-16 12:53:52 Target Skills & Keywords : Risk Management About the job Experience: •10+ years of progressively responsible experience in biologics process development/technical operations, with upstream or downstream focus and/or MSAT. Required Skills: •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). •Partner cross-functionally 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. •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. Compensation: •$170,000 - $225,000 / year Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!