JOB DESCRIPTION
Contract Type
Candidate (Freelancer)
Company Type
Biotech
Company Size
Startup < 100
Requested Expertise
Pharmaceutical Product Development / Pre-Clinical Research / Production / Logistics
Profile Required
• 10-15 years of experience in manufacturing process development within a GMP environment.
o Experienced in the formulation and development of injectable dosage forms.
Experience in microencapsulation of drugs is a plus.
Experienced in emulsification, tangential flow filtration and freeze-drying.
o Experienced in process development and scale-up.
• Strong knowledge of regulatory requirements and guidelines, particularly those of the FDA (EMA knowledge is a plus).
• Experience in Module 3 writing for FDA submissions is an advantage.
• Proven ability to excel in an agile and fast-paced environment, demonstrating high adaptability and the ability to work efficiently under tight timelines.
Project Description
We are a pioneering biotech company located in Lyon (France) and specializing in the innovative development of custom-designed, injectable, and biodegradable micro-implants. Our work focuses on advanced drug delivery systems to enhance critical healthcare outcomes. With a strong emphasis on developing patented, safe, and effective local therapies, we are dedicated to pushing the boundaries of medical innovation.
Job Description:
We are seeking an experienced Manufacturing Process Scientist to join our Pharmaceutical Development team on a contract basis.
This role involves technical supervision and support for drug product process development at a Contract Manufacturing Organization (CMO) targeting clinical Phase 2 stage.
The successful candidate will play a crucial role in ensuring the technical link between our company and the process development team at the CMO ensuring that all technical and regulatory requirements are met throughout the drug product manufacturing process development and GMP release, particularly focusing on sustained release injectable formulations of small molecules.
Key Responsibilities:
• Provide technical supervision and support for manufacturing process development and confirmation at the CMO.
• Critically review documentation issued by the CMO.
• Ensure technical and regulatory requirements are fulfilled throughout development for the intended phase of drug product development and testing.
• Write and review sections of Module 3 IND submissions.
Language Requirements:
• Proficiency in English is mandatory.
• Engage in day-to-day discussions in both French and English.
• Prepare and review documentation in English.
Work Location and Travel:
• Work primarily from a home office.
• Travel to CMO or client sites (approximately once per month).
Expected Workload:
• 1 day up to 2.5 days per week.
Duration of Mission:
• 18 months, with the possibility of extension.
Therapeutic Area
Inflammation,All
Language
English
Hard Skills
Experience > 10 years
Soft Skills
Agility,Responsibility,Team Player,Adaptability,Initiative
Seniority Level
Experience > 10 years
Starting Date
2024-09-15
Project Duration
18 months
FTE / nb of days per week
2
Project Location
total remote possible , France
Remote Flexibility
Yes
Travel Expected
No
Approximative Budget
Any other information of interest
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contact@pharmatch.co