Project Manager, Chemistry, Manufacturing & Controls (CMC)

Missions:

• CDMO management for CMC development & clinical trial supply activities on defined projects

-Contribute to CDMO or academic partner identification, selection and collaboration set-up process (CDA preparation, Request for Proposal drafting, quote analysis, MSA-QTA set-up in partnership with legal and QA managers, ATX-Partner collaboration management tools…)

-Monitor development plan execution, timelines & deliverables, identify and escalate risks

-Lead regular project meetings with CDMOs, produce/review agendas & minutes, monitor and complete CDMO action tracker

-Ensure compliance of activities with applicable guidelines, quality references & budget

-Review and manage technical documentation (recording in intranet & sharepoints, version follow-up, communication tracking), analyze and interpret results

-Suggest additional activities to the development plan based on project progress and challenges to identify solutions, challenge CDMO proposals on the plan

• Collaboration with project team members & external experts

-Work closely with Scientific and Development team to collaborate on new formulations which would be valuable to develop in early-stage R&D projects

-Work closely with Quality Operations team to manage quality events (deviations, OOS/OOT, change controls) and ensure Good Manufacturing Practices (GMP) compliance

-Work closely with the Regulatory team to complete and update CMC regulatory documentation (Module 3 of IMPD &IND, briefing package…)

-Work closely with Clinical Operations team to coordinate clinical trial supplies, conduct IMP management and gather IMP documentation for Trial Master File

-As needed, request & prepare meetings with external experts, draft and distribute agendas & minutes

• Reporting, action follow-up and communication with project and executive teams

-Complete internal trackers for project action follow-up

-Share progress of development activities during Monthly Project Meetings

-Produce material to support decision making

• Contribution to CMC department transversal activities

-Supply & consolidate CMC database

-Manage stock, supply & dispatch activities

-Write and update CMC Standard Operating Procedures

-Contribute to continuous improvement initiatives to enhance product quality, efficiency, and cost-effectiveness, in close collaboration with external partners / CDMOs

• Literature research & technological/regulatory intelligence in accordance with project needs (excipients, formulation techniques, guidelines…)

-Summarize and communicate on information of interest

-As needed, suggest product or process development strategies adapted to ATX Programs

-Work closely with legal and IP teams to ensure the protection of intellectual property through patents when relevant

 

Skills:

– Proven experience in CMC project management, ideally within biotech or pharmaceutical development

– Strong understanding of drug development processes and regulatory frameworks

– Experience working with CDMOs and managing external collaborations

– Excellent organizational and communication skills

– Ability to thrive in an international, dynamic and cross-functional environment

– Scientific background (Pharma, Biotech, Chemistry, or related field) required

– Experience in parenteral forms pharmaceutical development is a plus

– Fluency in English is a must-have, French language skills would be a major plus

 

Training and Experience:

– PharmD, MSc/PhD in biotechnology or chemistry or chemical engineering

– 2-5 years experience as scientist in the pharmaceutical/biotech industry

 

Perks

Meal vouchers and on-site restaurant

Public transport contribution

Gym and collective classes access

Concierge

 

To apply, please send your CV and cover letter application to jobs@aurobac-tx.com mentioning the reference ATX25-05.

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2025.09.16 Job Ad CMC Project Manager Job Ad (ATX25-05)