Bioprocess Expert ADC

Bioprocess Expert ADC

Pierre Fabre

Toulouse, France

Your mission

We are recruiting a Bioprocess Expert in Antibody-Drug Conjugates (ADC) and next generation conjugates (“XDC” such as BsADCs, Dualpayload ADCs, AOCs…) for CMC on a permanent contract for our Toulouse site (Oncopole, 31), reporting to Pierre Fabre Pharma's R&D Department.

You will be responsible for the development of drug substance (ADC-DS) and manufacturing of new ADC and biologic drug candidates.

This includes the development, optimization, and characterization of bioprocesses for ADCs by defining and executing CMC strategy for these preclinical and clinical programs, ensuring robust, compliant manufacturing processes and high-quality clinical and commercial supplies.

Your role within a pioneering company in full expansion

More specifically, you will:

• Lead CMC strategy for ADC programs from early development (“Developability”) through commercialization (Drug Substance, Linker-Payload, and Conjugation process) in collaboration with the other CMC experts in Analytical Development and formulation (ADC-DP, liquid formulation and lyophilized);
• Design and oversee bioprocess development, including upstream cell culture (mAb, BsAb production Drug Substance Intermediate, DSI) and downstream purification for ADC intermediates and final conjugates, Use of DoE for conjugation optimization and Process robustness studies;
• Drive process scale-up and tech transfer with external manufacturing sites (CMOs/CDMOs);
• Understanding of ADC-specific analytical methods (HIC, CE-SDS, LC-MS peptide mapping, free drug assays);
• Develop and implement control strategies, specifications, and process validation plans for ADCs based on Critical Quality Attributes (DAR, DLD, residual SMDs, charge, size and other variants…);
• Propose a pharmaceutical strategy in line with its bioprocess expertise and ensure that it is transcribed into dossiers as a bioprocess expert. Carry out CMC quality reviews (module 3) of DS and project dossiers as an in-house and provide bioprocess expertise as part of Due Diligences;
• Provide technical leadership in process risk assessments, comparability studies, and process improvements of ADC products during development and lifecycle;
• Provide bioprocess expertise for all requests, as well as technological and CMC watch. You are responsible for the CMC Work Package for new projects, in cross-functional collaboration with clinical, non-clinical, research, regulatory, quality and other departments;
• You will be responsible for monitoring work in line with this strategy, in terms of quality/cost/timeframe, with internal departments and subcontractors, and will provide expert support and scientific guidance to CMC OutSourcing Managers (OSM);
• Represent Pierre Fabre's CMC bioprocess expertise to the authorities in case of questions. You draft and/or check the quality module for DS parts of INDs, IMPDs, BLAs/MAAs, including questions and answers to the authorities (FDA, EMA, NMPA and other authorities);
• Define and manage the bioprocess budget for all development phases;
• Support as bioprocess expert internal life cycle management programs and regulatory changes for assets and raw materials.

Who you are ?

Your skills at the service of innovative projects:

• Biochemical engineer or PhD in Biotechnology/Bioprocess;
• Minimum 10 years' experience in bioprocess development for biologics with direct ADC experience (conjugation, linker-payload, HPAPI handling);
• Proven track record in CMC strategy through several clinical studies (phase 1 to phase 3) ideally up to registration, regulatory submissions, and interactions with health authorities;
• Strong knowledge of ICH guidelines, cGMP, and quality-by-design (QbD) concepts for biologics/ADCs;
• Experience of technical leadership in bioprocess and project management associated with development programs is required;
• You have managed CDMOs;
• Fluent English essential;
• Excellent communication skills and ability to lead cross-functional CMC teams.