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Senior Director CMC
hace 3 semanas
Get AI-powered advice on this job and more exclusive features. Direct message the job poster from Discover International Senior Consultant | Tech Ops | Pharma & Biotech Director / Senior Director, CMC (Chemistry, Manufacturing & Controls) Confidential | Next-Generation Bioconjugate Therapeutics | Flexible Location A fast-growing, well-funded biotechnology company developing next‑generation hybrid biologic/nucleic acid therapeutics is seeking an experienced Director / Senior Director, CMC to lead all CMC strategy, development, and execution from early R&D through clinical supply. This is a rare opportunity to shape the CMC function for an emerging platform and play a pivotal role in advancing transformational therapies. The team welcomes applicants across Europe and beyond, with flexible hybrid/remote options for exceptional candidates. The Role Define and deliver an integrated CMC strategy supporting early development to first‑in‑human studies Lead cross‑functional planning, risk assessments, and decision‑making at the interface of R&D, Quality, Regulatory, and external partners Oversee process development for both biologic and nucleotide‑based components, including conjugation and purification Guide tech transfers and manufacturing with global CDMOs (DS & DP) Direct analytical method development and characterization for complex bioconjugates Lead CMC authoring for regulatory submissions (pre‑IND, IND/IMPD) Partner with Quality to implement phase‑appropriate systems supporting cGMP operations Manage vendor selection, contracting, and performance oversight Represent CMC in leadership updates, program reviews, and regulatory discussions What We’re Looking For Ph.D. or M.S. in Chemistry, Biochemistry, Chemical Engineering, Pharmaceutical Sciences, or related field 10+ years of CMC experience in biologics, bioconjugates, ADCs, or synthesis of nucleic acid polymers Strong expertise in process development, analytical development, and cGMP manufacturing Solid understanding of bioconjugation chemistry and/or nucleic acid synthesis Experience leading CMC content for regulatory filings and engaging with authorities Demonstrated success managing CDMOs across early‑stage development Comfortable working in a fast‑paced, entrepreneurial biotech environment Preferred: experience with complex conjugate modalities, early‑stage biotech, or AI‑assisted CMC analytics. Why This Role? Influence CMC strategy and infrastructure from the ground up Work on a technically exciting and emerging therapeutic class Collaborate with a world‑class scientific team and top‑tier external partners Competitive compensation, equity, and flexible working options Seniority Level Director Employment Type Full‑time Job Function Manufacturing, Research, and Project Management Industries Pharmaceutical Manufacturing, Biotechnology Research, and Chemical Manufacturing #J-18808-Ljbffr
