Bioprocess Expert ADC- CDI - M/F

## Bioprocess Expert ADC- CDI - M/FApplylocations: Haute Garonne (31)time type: Full timeposted on: Posted 2 Days Agojob requisition id: JR # ****Who we are ?****We are Pierre Fabre Laboratories, a global leader combining pharmaceutical expertise with dermo-cosmetics to support consumers and patients at every stage of their care journey. Our portfolio includes several medical franchises and international brands such as Eau Thermale Avène, Ducray, A-Derma, Klorane, René Furterer, and Pierre Fabre Oral Care. By joining us, you become part of a meaningful company where the human dimension is essential. You become a participant in the "We Care Movement," a movement that values excellence and innovation within passionate teams. Together, we push the boundaries of science to unite health and beauty for the benefit of all, because Every time we care for a single person, we make the whole world better. Present in 120 countries with a team of over 10,000 employees, we are proud to create a scientific and human impact, today and tomorrow! If caring is at the heart of your values, join Pierre Fabre Laboratories and become a key player in the “We Care Movement".# ****Your mission****We are recruiting a **Bioprocess Expert in Antibody-Drug Conjugates (ADC) and next generation conjugates (“XDC” such as Bs

ADCs, 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 (m

Ab, Bs

Ab production Drug Substance Intermediate, DSI) and downstream purification for ADC intermediates and final conjugates, Use of Do

E 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 Out

Sourcing 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

This position is compatible with teleworking up to 2 days a week according to company rules.

We offer an attractive remuneration/benefits package: 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, very attractive CE...# # ****Who you are ?****#**Your skills at the service of innovative projects:**- Biochemical engineer or Ph

D 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, c

GMP, and quality-by-design (Qb

D) 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

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