Consultant - Peptide DS Manufacturing & Formulation Development

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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

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

• 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 pre‑clinical/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.