Hiring: Director, CMC Product Development – Biologics Company: Beeline Medicines Location: Durham, NC Job Posted Time: 2026-09-17 12:00:16 Employment Type: Hybrid Target Skills & Keywords : Risk Management About the job Experience: •10+ years of CMC biologics experience with demonstrated expertise in drug product formulation and/or fill-finish process development in pharmaceutical and/or biotechnology industry Required Skills: •This position follows a hybrid work schedule, requiring a minimum of two (2) days on-site per week — currently designated as Tuesday and Wednesday •. Additional on-site days may be required based on business needs, team priorities, or leadership direction. •Define and execute the biologics drug product development strategy, encompassing formulation development, fill-finish process development, primary container-closure selection, and device development where applicable. •Lead formulation development activities for protein-based therapeutics, including excipient screening, formulation optimization, forced degradation, and compatibility studies. •Oversee drug product process development and scale-up, including fill-finish requirements, technology transfer to CDMO partners, process characterization, and validation readiness. •Author and review biologics drug product sections of regulatory submissions (IND, BLA, Type A/B meeting packages) and lead or support FDA/EMA interactions on drug product CMC topics. •Select and technically govern CDMO partners responsible for biologics drug product manufacture, including clinical supply chain coordination, change control oversight, and deviation management. •Partner cross-functionally with Analytical Development to define drug product release and stability specifications, in-process controls, and comparability strategies for process and formulation changes. Qualifications: •Deep technical expertise in biologics formulation science, including protein stability, aggregation mitigation, excipient selection, lyophilization cycle development, and container-closure systems. •Comprehensive knowledge of ICH Q8/Q9/Q10/Q11, relevant biologics CMC guidelines (Q5A–Q5E), and FDA/EMA drug product development expectations; experience authoring BLA drug product sections. •Proven experience managing biologics drug product CDMO relationships, including technical oversight of fill-finish operations, process scale-up, process qualification, and commercial readiness. •Solid functional working knowledge of biologics drug substance processes (upstream/downstream) sufficient to effectively partner with Drug Substance teams on interface activities and integrated CMC planning. •Demonstrated success in operating effectively in pre-commercial, resource-constrained environments — balancing strategic vision with hands-on execution and infrastructure building. •Exceptional ability to translate complex CMC biologics science into clear, decision-ready narratives for executive leadership, cross-functional partners, and non-technical stakeholders. •Strong written and verbal communication skills, with a track record of authoring high-quality regulatory documents, scientific reports, and executive-level presentations. •Collaborative communication style with the ability to establish trust quickly across Research, Clinical, Regulatory, Quality, and external partners in a matrixed organization. Compensation: •$217,000 - $226,750 / year •Competitive benefits and rewards package •A discretionary annual bonus and long-term incentive award (e 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!