JOB DESCRIPTION
Contract Type
Candidate (Freelancer)
Company Type
Pharma
Company Size
Middle 1000 – 5000
Requested Expertise
Pharmaceutical Product Development / Production / Logistics / Clinical study / Clinical development
Profile Required
Skills
• 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
Ophthalmology
Language
English,French
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
2024-09-02
Project Duration
6 months minimum
FTE / nb of days per week
3
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
Yes
Travel Expected
Yes
Approximative Budget
Any other information of interest
or recommend someone & get 1000€ from pharmatch.co !
contact@pharmatch.co