JOB DESCRIPTION
Contract Type
Candidate (Freelancer)
Company Type
Biotech
Company Size
Startup < 100
Requested Expertise
Pre-Clinical Research / Pharmaceutical Product Development / Start-Up and Innovation
Profile Required
• 10-15 years of experience in analytical method development and validation within GLP and GMP environments.
o Proficiency in HPLC, GC, and Coulometry.
o Experience with particle size distribution (laser light diffraction).
o Skilled in dissolution testing.
• Experience with injectables, particularly complex dosage forms.
• Prior experience working at a CMO is a plus.
• 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 seeking an experienced Analytical Development Scientist to join our Pharmaceutical Development team on a contract basis. This role involves technical supervision and support for analytical methods development, validation, and implementation at a Contract Manufacturing Organization (CMO) during the preparation for clinical Phase 2 stage.
The successful candidate will play a crucial role in ensuring the technical link between our company and the analytical development team at the CMO. The candidate will ensure that all regulatory and analytical requirements are met throughout the drug product development and testing process, particularly focusing on sustained release injectable formulations of small molecules.
Key Responsibilities
• Provide technical supervision and support for analytical methods development, implementation and validation at the CMO. Transfer between CMO sites can be envisoned.
• Critically review and validate analytical documentation issued by the CMO.
• Ensure regulatory and analytical requirements are fulfilled throughout development and validation for the intended phase of drug product development and testing.
• Write and review analytical 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.
• Occasional travel to CMO or client sites (approximately once per month).
Expected Workload
• 1 to 2.5 days per week.
Duration of Mission
• 12 months, with the possibility of extension.
Therapeutic Area
All
Language
English
Hard Skills
Biotechnology experience,Experience > 10 years
Soft Skills
Adaptability,Analytical skills,Autonomous / self-management,Collaboration
Seniority Level
Experience > 10 years
Starting Date
2024-09-15
Project Duration
12 months
FTE / nb of days per week
2
Project Location
France, total remote possible , France
Remote Flexibility
Yes
Travel Expected
No
Approximative Budget
Any other information of interest
or recommend someone & get 1000€ from pharmatch.co !
contact@pharmatch.co