Project 55219 – Senior CMC Project Leader



Contract Type

Candidate (Freelancer)

Company Type


Company Size

Middle 1000 – 5000

Requested Expertise

Pharmaceutical Product Development / Production / Logistics / Clinical study / Clinical development

Profile Required

• English working environment with international team and CMO worldwide
• Minimum 10Y of experience in the CMC area in the pharmaceutical industry / pharmaceutical drug development.
• Project Management skills with ability to coordinate and animate subteam members.
• Ability to analyse large amount of data, define objectives, make priorities, and take decisions.
• Team player
• Good knowledge in oligonucleotides field and injectable products is requested
• Autonomy

Project Description

Scope of activities: CMC scope corresponding to Module 3 of CTD document, including Drug Substance and Drug Product parts.

Main responsibilities
• Pharmaceutical development of new chemical entities currently in clinical development.
• Drug Substance and Drug Product manufacturing process development follow up.
• Drug Substance and Drug Product analytical methods development follow-up.
• Preparation of clinical supply (GMP batches of Drug Substance and Drug Product)
• Management of several CMO worldwide
• Schedule and organize all CMC activities to deliver IMP and IMPD / IND according to clinical planning expectations.
• Writing / reviewing of technical documents (protocols / reports) from the CMC scope
• Participation to the different project team meetings
• Reviewing CMC section from R&D documents related to the projects (ex : IB, clinical protocol, etc..)
• Evaluation of risks and ability to propose risk mitigation measures.

Regulatory environment
• Drug status.
• GMP rules.
• ICH guidances.
• Eur Pharm and USP.
• IMPD and IND dossiers.

Therapeutic Area




Hard Skills

Experience > 10 years,Fluency in English,Fluency in French,PharmD,PhD,Project Management Office

Soft Skills

Adaptability,Agility,Analytical skills,Autonomous / self-management,Collaboration,Coordination,Decision making,Entrepreneurial mindset,Initiative,Multi-cultural work,Team Player

Seniority Level

Experience > 10 years

Starting Date


Project Duration

6 months minimum

FTE / nb of days per week


Project Location

Essentially remote work with some face-to-face meetings (1-3 per month) to be planned according to the needs. Possibility to travel some days to visit CMO (US and Europe), 3 days / week minimum as starting point, could be potentially 4 days / week., France

Remote Flexibility


Travel Expected


Approximative Budget

Any other information of interest

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