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Aseptic Production Leader - Paris (CDMO)

PARIS, 75
il y a 12 jours

Production Manager – Sterile Manufacturing

Location: Paris, France

Industry: Pharmaceutical Manufacturing

Overview

We are supporting a leading sterile CDMO in the Paris region seeking a Production Manager to lead aseptic manufacturing operations. This role is critical in ensuring the reliable, compliant, and efficient delivery of sterile drug products for global pharmaceutical clients.

This opportunity is exclusively represented by Barrington James.

You will oversee day-to-day production, drive operational excellence, and ensure full compliance with EU GMP standards, while developing high-performing teams in a fast-paced CDMO environment.

Key Responsibilities

Manufacturing & Operations

  • Lead all sterile production activities (aseptic filling, lyophilisation, compounding if applicable)
  • Ensure production schedules are delivered on time and in full (OTIF)
  • Drive continuous improvement across yield, efficiency, and batch success rates
  • Support scale-up, technical transfer, and new product introduction (NPI)

Quality & Compliance

  • Ensure full compliance with EU GMP , aseptic processing standards, and data integrity requirements
  • Own deviation investigations, CAPAs, and batch record review
  • Support regulatory inspections (e.g. EMA, ANSM, FDA) and client audits
  • Embed a strong quality culture across production teams

Leadership & People Management

  • Lead, coach, and develop a team of supervisors, shift leaders, and operators
  • Build a high-performance culture focused on accountability and continuous improvement
  • Manage workforce planning, training, and succession development
  • Act as a key interface for external clients regarding manufacturing activities
  • Support project delivery timelines and ensure client satisfaction
  • Collaborate cross-functionally with QA, QC, MSAT, and Supply Chain

Operational Excellence

  • Implement Lean / Six Sigma principles to optimise manufacturing performance
  • Track and improve KPIs (OEE, right-first-time, deviation rates, OTIF)
  • Contribute to site strategy and capacity expansion initiatives

Required Experience & Background

  • Significant experience in sterile pharmaceutical manufacturing (aseptic / fill-finish essential)
  • Proven leadership experience within a GMP-regulated environment
  • Strong understanding of EU GMP , aseptic processing, and regulatory expectations
  • Experience in a CDMO environment highly desirable
  • Track record of managing deviations, CAPAs, and inspections
  • Strong leadership and team development capability
  • Operationally driven with a continuous improvement mindset
  • Ability to operate in a fast-paced, client-facing environment
  • Excellent problem-solving and decision-making skills
  • Strong communication skills in cross-functional and international settings

Education

  • Degree in Life Sciences, Engineering, Pharmacy, or related field

Why Join

  • Opportunity to play a key role in a growing sterile CDMO
  • High level of visibility with senior leadership and clients
  • Involvement in tech transfers, new product launches, and site growth
  • Dynamic, international working environment

Nice to Have

  • Experience with lyophilisation or complex sterile formulations
  • Exposure to Annex 1 (latest revision) implementation
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Entreprise
Barrington James
Plateforme de publication
WHATJOBS
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