Project Manager, Chemistry, Manufacturing & Controls (CMC) (ATX24-09)

Missions

• Manage process development, analytical and stability activities conducted by external subcontractors
  – Monitor development plan execution, timelines & deliverables, identify and escalate risks
  – Review technical documentation, analyze and interpret results
  • – Lead weekly project meetings with subcontractors, produce/review agendas & minutes
• Interact & collaborate with project team members & external experts
  – Work closely with Clinical Operations team to coordinate clinical trial supplies
  – Work closely with Quality Operations team to manage quality events (deviations, OOS/OOT, change controls) and ensure Good Manufacturing Practices (GMP) compliance
• Ensure communication with project and executive teams
  – Share progress of development activities during monthly project meetings
  – Complete trackers for project activities follow-up-
  – Produce material to support decision making
  – As needed request & prepare meetings with external experts, draft and distribute agendas & minutes
• Contribute to CMC department transversal activities- Supply & consolidate development trackers (clinical batch history, manufacturing parameters & results, stability timepoints & results)

  – Manage stock, supply & dispatch activities

• Carry out literature research & technological/regulatory intelligence in accordance with project (excipients, formulation techniques, guidelines…)

Skills

• Strong knowledge of formulation, process and analytical development
• Good knowledge of Good Manufacturing Practices
• Experience in subcontractor management is required
• Experience in parenteral forms pharmaceutical development  is a plus
• The candidate is rigorous, involved and demonstrates good organizational and communication skills
• Fluency in English is a must-have, French language skills would be a major plus
• Used to working in an international environment

Professional experience

• PharmD, Master of science in biotechnology or chemistry or chemical engineering
• At least 2 years experience as scientist in the pharmaceutical industry

To apply, please send your CV and cover letter application to jobs@aurobac-tx.com mentioning the reference ATX24-09.

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2024.11.21 ATX24-09 Job Ad CMC Project Manager