Antibody-Drug Conjugates (ADCs) Consultant

Overview DesignSpaceinPharmatics, the North American division of Product Life Group (PLG), a leading international pharmaceutical consulting organization, is seeking an experienced ADC (Antibody‑Drug Conjugate) Scientist Consultant to provide deep technical and CMC expertise across ADC development programs. This is a hands‑on, high‑impact role for someone who combines strong bench‑level and process‑science knowledge of cell lines, linkers, and payloads with the strategic and regulatory fluency needed to design and execute a complete CMC program that spans from early development through market authorization. The ideal consultant has navigated the full ADC CMC lifecycle, including drug substance and drug product development, CDMO selection and oversight, analytical and control strategy design, and the regulatory filings that carry a molecule from IND and IMPD through BLA and MAA. This is a role for a subject‑matter expert who can shape strategy at the program level while also troubleshooting technical issues on the ground. CMC Program Design & Execution Design and lead the overall CMC strategy for ADC molecules across the full development lifecycle, spanning early‑phase development through clinical development and into market authorization. Define the development roadmap for drug substance, covering the antibody, linker, payload, and conjugation, as well as for drug product, covering formulation and fill‑finish, ensuring alignment with clinical timelines and regulatory milestones. Integrate scientific decision‑making across cell line selection and development, linker chemistry, and payload characteristics to ensure a manufacturable, stable, and clinically viable ADC. Anticipate and plan for ADC‑specific CMC complexities, including Drug‑to‑Antibody Ratio (DAR) control, conjugation‑site specificity, and payload and linker stability throughout the supply chain. CDMO Selection & Management Manage day‑to‑day CDMO relationships and performance, including timelines, deviations, batch records, and contractual deliverables across both drug substance and drug product workstreams. Serve as the technical point of contact between the client organization and CDMO partners, resolving cross‑functional and cross‑site issues as they arise. Design and oversee analytical method development, qualification, and validation strategies that address ADC‑specific critical quality attributes (CQAs), including DAR, aggregation, free payload and linker, and potency. Develop the overall control strategy, including specifications, in‑process controls, and release and stability testing, inline with ICH guidelines such as ICH Q6B, Q8, Q9, Q10, and Q11. Ensure control strategies remain fit for purpose as the program progresses from early development through commercial readiness. Regulatory Documentation Prepare and review CMC sections of regulatory submissions across the full development arc, from IND in the US and IMPD in the EU through to BLA and MAA for market authorization. Ensure regulatory documentation reflects current agency expectations for ADC characterization, comparability, and control strategy across the FDA, EMA, and other relevant health authorities. Support responses to health authority information requests and participate in regulatory interactions concerning CMC content. Risk Management & Technical Troubleshooting Lead root‑cause investigations and troubleshooting for manufacturing deviations, analytical anomalies, or process inconsistencies, such as DAR variability, aggregation, or conjugation efficiency issues. Qualifications & Education Requirements Comfortable operating independently across multiple concurrent client engagements, prioritizing competing deadlines without close supervision. Preferred Skills ADCTechnicalExpertise (Imperative) Strong, demonstrable ADC‑specific knowledge across the following areas is considered essential for this role. Cell lines, including cell line development and selection and an understanding of how these choices affect antibody quality attributes relevant to conjugation and downstream ADC performance. Linkers, including cleavable and non‑cleavable linker chemistries, their stability in circulation, and their impact on the therapeutic index. Payloads, including cytotoxic payload classes such as auristatins, maytansinoids, calicheamicins, and topoisomerase inhibitors, along with their potency, stability, and safety considerations. ADC development and GMP production, including the process, analytical, and containment considerations that differentiate ADC manufacturing from standard biologics manufacturing. CMC & Regulatory Experience Demonstrated experience designing and executing CMC programs for biologics or ADCs, from early development through market authorization. Direct experience selecting, qualifying, and managing CDMOs for both drug substance and drug product. Hands‑on experience authoring and reviewing CMC content for IND, IMPD, BLA, and MAA submissions. Additional Notes The responsibilities outlined in this position represent a general summary of the consulting role and are not intended to be all‑inclusive. PLG reserves the right to amend this description as client program needs evolve. All applications are reviewed by our human hiring team. No automated screening or AI‑based filtering is used to evaluate or eliminate candidates. Every candidate receives personal consideration. #J-18808-Ljbffr DSI - Design Space InPharmatics LLC