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 10000 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 BsADCs Dualpayload ADCs AOCs) for CMC on a permanent contract for our Toulouse site (Oncopole 31) reporting to Pierre Fabre Pharmas 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 Fabres 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...

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

At Pierre Fabre Laboratories we believe that our greatest asset is our people.

We are committed to a policy of Equal Employment Opportunity and will not discriminate against an applicant or employee based on race color religion creed national origin or ancestry sex sexual orientation gender identity or expression age physical or mental disability veteran or military status genetic information or any other legally recognized protected basis under federal state or local law. The information collected by this application is solely to determine suitability for employment verify identify and maintain employment statistics on applicants. Applicants with disabilities may be entitled to reasonable accommodation under the Americans with Disabilities Act and certain state or local laws. Please inform the companys personnel representative if you need assistance completing this application or to otherwise participate in the application process. Thus we commit to considering all applications equally without fail.