JOB DESCRIPTION
Contract Type
Candidate (Freelancer)
Company Type
Pharma
Company Size
Middle 1000 – 5000
Requested Expertise
Pharmaceutical Product Development / Regulatory Affairs /
Profile Required
. Minimum 10 years of experience in drug substance process development, a focus on oligonucleotide therapeutics will be a plus.
. 10 years or more experience in the pharmaceutical/biotech sector specializing in late-stage cGMP drug substance manufacture.
. Proven track record in analytical development supporting drug substance manufacturing.
. Strong understanding of GMP, ICH guidelines, and regulatory expectations for late-stage development.
. Excellent project management and interpersonal skills; ability to lead cross-functional teams and manage complex projects.
. Business fluency in English is required, French is a strong asset.
. Advanced degree (PhD or MSc) in chemistry, biochemistry, pharmaceutical sciences, or related field preferred.
Project Description
A senior drug substance independant consultant is required to support activities for a key strategic project for a well-known French Pharmaceutical Industry during 2026 with an extension possible.
• Lead and advise on late-stage process development of oligonucleotide drug substance manufacturing (PPQ batches).
• Collaborate with cross-functional teams including analytical development, quality, and regulatory affairs to ensure robust and compliant processes.
• Provide strategic input into process optimization, risks evaluation and technology transfer activities.
• Drive project execution, ensuring timelines, budgets, and deliverables are met.
• Communicate effectively with internal stakeholders and external partners, including CDMOs and regulatory bodies.
• Build and execute the process validation strategy with the selected CDMO, to meet EU and US regulations
• Participate to regular project team meetings and especially be part of the CMC sub-team as Drug Substance Leader
• Evaluate risks, alert if needed and propose risk mitigation measures.
• Participate to the regulatory strategy to prepare Drug Substance sections for NDA/CTD submissions
• Review of all technical documentations from CDMO and sections for NDA/CTD submissions
. Delivery of the DS activities carried out at the selected CMO including PPQ batches, review of all technical documentation and preparation of
DS sections for the NDA/CTD sections.
Therapeutic Area
Ophthalmology
Language
English,French
Hard Skills
Consultancy Experience
Soft Skills
Collaboration
Seniority Level
Experience > 10 years
Starting Date
2026-02-02
Project Duration
1 year with an extension possible
FTE / nb of days per week
3
Project Location
N/A – Job will be remote with travelling necessary to support the activities (EU and/or US) , N/A
Remote Flexibility
Yes
Travel Expected
Yes
Approximative Budget
Any other information of interest
or recommend someone & get 1000€ from pharmatch.co !
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