Bioprocess Expert ADC- CDI - M/F

About the Role

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.

Responsibilities

• Lead CMC strategy for ADC programs from early development ("Developability") through commercialization.
• Design and oversee bioprocess development, including upstream cell culture and downstream purification for ADC intermediates and final conjugates.
• Use DoE for conjugation optimization and conduct process robustness studies.
• Drive process scale‑up and tech transfer with external manufacturing sites (CMOs/CDMOs).
• Understand and implement 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.
• Propose a pharmaceutical strategy and ensure its transcription into dossiers as a bioprocess expert.
• Carry out CMC quality reviews (module3) of DS and project dossiers and provide bioprocess expertise during due diligence.
• Provide technical leadership in process risk assessments, comparability studies, and process improvements.
• Manage the CMC work package for new projects and coordinate with clinical, non‑clinical, research, regulatory, quality and other departments.
• Monitor work against quality, cost, and timeframe objectives and provide support to CMC Outsourcing Managers.
• Represent Pierre Fabre’s CMC bioprocess expertise to regulatory authorities (FDA, EMA, NMPA and others).
• Draft and/or review quality modules for DS parts of INDs, IMPDs, BLAs/MAAs and interface with authorities.
• Define and manage the bioprocess budget for all development phases.
• Support internal life‑cycle management programs and regulatory changes for assets and raw materials.

Qualifications

• Biochemical engineer or PhD in Biotechnology/Bioprocess.
• Minimum 10 years of experience in bioprocess development for biologics with direct ADC experience.
• Proven track record in CMC strategy through multiple clinical studies (phase1 to phase3) and regulatory submissions.
• Strong knowledge of ICH guidelines, cGMP, and QbD concepts for biologics/ADCs.
• Experience providing technical leadership in bioprocess and project management associated with development programmes.
• Experience managing CDMOs.
• Fluent in English.
• Excellent communication skills and ability to lead cross‑functional CMC teams.

Benefits

We offer an attractive remuneration and benefits package, including incentives, profit‑sharing, Pierre Fabre shareholding with matching contribution, health and provident insurance, 16 days of holidays (RTT) in addition to 25 days of personal holidays, public transport participation, and other attractive benefits. Teleworking up to 2 days per week is allowed.

Equal Employment Opportunity

We are committed to an equal employment opportunity policy and do not discriminate based on race, color, religion, creed, national origin or ancestry, sex, sexual orientation, gender identity or expression, age, disability, veteran or military status, genetic information, or any other legally recognized protected basis.