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Proclinical is partnering exclusively with a clinical stage pharmaceutical company in the Paris region, to appoint a senior peptide development expert to lead CMC delivery for a long synthetic peptide programme moving rapidly towards first in human (Phase I).
This is a high impact contract role for someone who can combine deep peptide technical expertise with hands on leadership across CDMO selection, tech transfer, scale up, formulation and CMC documentation.
Key details
- Contract day rate: €1,000-€1,100/day + expenses (travel to site and CDMOs).
- Location: Paris area, France. Minimum 3 days per week on site, plus occasional CDMO visits.
- Start: Targeting June 1st (flexible for the right consultant).
- Reporting line: VP, Product Development.
Role overview
You will lead the strategic and technical aspects of peptide drug substance development and formulation development to support progression through regulatory non clinical studies and Phase I clinical supply, including selecting and managing specialist partners (CDMOs).
Key Responsibilities will include:
Peptide Drug Substance (DS)
- Lead process transfer, process development and optimisation for a synthetic peptide drug substance intended for non clinical and clinical use.
- Oversee scale up and ensure appropriate GMP alignment as the programme transitions into clinical supply.
Drug Product (DP) / Formulation
- Define and drive formulation strategy and execution for injectable peptide formulations (with exposure to liquid and/or freeze dried (lyophilised) options).
- Guide stability strategy (including degradation pathways), excipient/pack compatibility and delivery considerations.
CDMO selection, management & governance
- Identify, evaluate and select suitable CDMOs (DS, DP and, if needed, analytical/QC partners).
- Lead CDMO relationships to ensure delivery to timeline, quality and regulatory expectations; run regular governance and risk management.
Analytical / Quality / CMC documentation:
- Drive analytical method development/validation strategy supporting identification, characterisation and quantification in DS/DP.
- Propose specifications and acceptance criteria for GLP tox / stability batches and GMP clinical batches; ensure documentation is inspection ready.
- Ensure robust documentation (batch records, protocols/reports, CoAs, validation packages) and support CMC inputs for regulatory submissions (e.g., IND/IMPD components).
Must-Have Experience:
We're looking for a peptide specialist who has experience in the following;
- Significant experience (10+ years) in peptide drug development, including leading DS/DP programmes and managing CDMOs.
- Deep expertise in synthetic peptides (chemical synthesis) and strong working knowledge of peptide process development and scale up.
- Strong background in formulation development for preclinical/clinical studies, including support for GLP tox and clinical readiness.
- Strong understanding of regulatory and quality frameworks (GMP; quality systems), with proven ability to produce high quality technical/regulatory documentation.
- Fluent French & English (onsite team integration and cross functional working are essential).
- Able to work minimum 3 days/week onsite in the Paris area and travel to CDMO sites as needed.
Education
- PharmD or PhD in Pharmaceutical Sciences (or closely related), with strong emphasis on peptide chemistry and formulation.
If you are having difficulty in applying or if you have any questions, please contact Neil Walton at n.walton@proclinical.com.
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
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