Analytical Development Scientist

il y a 7 jours

Lyon, France Actalent Temps plein

n/a

We are looking for an experienced Analytical Development Scientist to join our clients Pharmaceutical Development team on a contract basis. This role involves providing technical supervision and support for the development, validation, and implementation of analytical methods at a Contract Manufacturing Organization (CMO) as they prepare for clinical Phase 2.

Role and Responsibilities:

- Provide technical supervision and support for the development, implementation, and validation of analytical methods at the CMO, with potential transfers between CMO sites.
- Critically review and validate analytical documentation issued by the CMO.
- Ensure regulatory and analytical requirements are met throughout the development and validation phases for the intended stage of drug product development and testing.
- Write and review the analytical sections of Module 3 IND submissions.

**Requirements**:

- Language Skills: Proficiency in both French and English is mandatory for day-to-day discussions and documentation.
- Travel: Occasional travel to CMO or client sites (once per trimester or semester) is expected.
- Workload: The expected workload will vary, starting at 20%, increasing to 50%, 12 month duration with possible extension

Desired Profile:

- 10-15 years of experience in analytical method development and validation within GLP and GMP environments.
- Proficiency in HPLC, GC, and Coulometry.
- Experience with particle size distribution (laser light diffraction).
- 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 writing Module 3 for FDA submissions is an advantage.

Please get in touch if you require further details.

**Job Title**: Analytical Development Scientist

**Location**: Lyon, France

**Job Type**: Contract

Job ID JP-004712989

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