CMC Project Lead - Biotechnology

We are currently supporting a true innovator in the field of Biotechnology who are continuing a promising Development direction for several applications. As part of their success to date, we are now looking to help expand the team with their newest addition for a ‘Pharmaceutical CMC Project Manager’. This role will be pivotal in the groups on-going Development activities and will include a range of interesting and diverse challenges.

Key Responsibilities

• Ensure the implementation and monitoring of the pharmaceutical development plan defined with the management team,
• Coordinate and monitor the production and release of pilot and clinical batches of both drug substance and drug product.
• Analyze, interpret and verify the consistency of the results with the expected product specifications.
• Supervise process improvement, development of analytical methods and distribution to our external partners (CROs, CMOs),
• To ensure the good achievement in terms of quality in accordance with the regulations (GMP, GMP, USP, EUP). Contribute to ensuring the control of the quality of the products developed and manufactured by the subcontractors for their clinical use,
• To be the guarantor of the quality and the good realization of the processes developed with international CMOs.
• Ensure that deadlines and costs as defined in advance with the management team are respected.
• Write regulatory documents required for regulatory submissions (IND and IMPD), registration dossiers
• Participate in the development of the company's patent portfolio by contributing to the filing of new patents

Skills needed

• 5-8 years exposure working within CMC ideally within a Biotechnology or Pharmaceutical group (CMO/CRO experience would also be suffice)
• Knowledge / control of batch drug substance and drug product batch processes in GMP environments
• Educated within a Life-Sciences or similar discipline to a BSc, MSc or PhD level  
• Fluent French and English
• Can ideally work office based in Central France or can travel once per week to the office (flexibility with home-based)
• Demonstrated skills ideally managing 3^rd parties (CMO/CRO’s.

If you feel you match the qualities we are looking for and the role appeals to you, please contact Antony Clark at RBW Consulting on +44 1293 or email me antony.clark@rbwconsulting.com