France Job Openings

Actalent

Analytical Development Scientist

Lyon

FULL TIME

August 30, 2024

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.
The successful candidate will be crucial in maintaining the technical link between the company and the CMO’s analytical development team. They will ensure that all regulatory and analytical requirements are met throughout the drug product development and testing process, with a particular focus on sustained release injectable formulations of small molecules. Are you ready to take your career to the next level in the heart of pharmaceutical innovation?
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

Trading as Aerotek. Allegis Group Limited, Maxis 2, Western Road, Bracknell, RG12 1RT, United Kingdom. No. 2876353. Allegis Group Limited operates as an Employment Business and Employment Agency as set out in the Conduct of Employment Agencies and Employment Businesses Regulations 2003. Aerotek and Actalent Services are companies within the Allegis Group network of companies (collectively referred to as "Allegis Group"). Aerotek, Actalent Services, Aston Carter, EASi, Talentis Solutions, TEKsystems, Stamford Consultants and The Stamford Group are Allegis Group brands. If you apply, your personal data will be processed as described in the Allegis Group Online Privacy Notice available at https://www.allegisgroup.com/en-gb/privacy-notices.
To access our Online Privacy Notice, which explains what information we may collect, use, share, and store about you, and describes your rights and choices about this, please go to https://www.allegisgroup.com/en-gb/privacy-notices.
We are part of a global network of companies and as a result, the personal data you provide will be shared within Allegis Group and transferred and processed outside the UK, Switzerland and European Economic Area subject to the protections described in the Allegis Group Online Privacy Notice. We store personal data in the UK, EEA, Switzerland and the USA. If you would like to exercise your privacy rights, please visit the "Contacting Us" section of our Online Privacy Notice at https://www.allegisgroup.com/en-gb/privacy-notices for details on how to contact us. To protect your privacy and security, we may take steps to verify your identity, such as a password and user ID if there is an account associated with your request, or identifying information such as your address or date of birth, before proceeding with your request. If you are resident in the UK, EEA or Switzerland, we will process any access request you make in accordance with our commitments under the UK Data Protection Act, EU-U.S. Privacy Shield or the Swiss-U.S. Privacy Shield

Job ID JP-004712989

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