Analytical Chemistry Officer H/F

Description du poste et des missions

Gi Group Consulting is an international consulting group with a turnover of €2.84 million and a growth rate of 25%. A family-owned company specializing in placing our talents within the healthcare industry, we place Human values at the core of our mission. We dedicate our expertise in Life Sciences to our clients: pharmaceutical groups, CROs, and biotech companies.

We are recruiting an Analytical Chemistry Officer (M/F) in the Gidy and Saclay region, France for a mission within a prestigious pharmaceutical group. Our client is committed to therapeutic progress for the benefit of patients. Its growth is based on the search for innovative solutions capable of addressing unmet needs in several research areas: oncology, immunology and inflammation, rare hematological diseases, rare and neurological diseases, diabetes and cardiovascular diseases, and vaccines.

As an Analytical Chemistry Officer (M/F), your mission will be to support the commercial manufacturing of Oral Solid Dosage (OSD) products. You will be responsible for supporting activities involved in analytical method transfers, the analytical aspects of technical transfers, and QC release testing of Oral Solid Dosage products at contract manufacturing organizations (CMOs).

Main responsibilities

• Analytical point of contact to support OSD manufacturing of APIs, reference standards, finished products at CMOs.


• Facilitate the technology transfer of analytical methods between different manufacturing sites both domestically and internationally.


• Work closely and effectively as the subject matter expert with internal colleagues and external CMO to manage analytical method activities in a timely manner.


• Work with relevant cross-functional stakeholders and with external CMO on technology transfer of analytical methods, analytical method validation and verification where applicable.


• Manage and review deviation events and OOS/OOT investigations at CMOs in coordination with QA and project team members, as appropriate.


• Design and manage stability programs. Review and analyze relevant stability data by utilizing industry standard modeling and analysis tools including regression analysis to provide guidance for shelf-life and expiry dating.


• Prepare technical documents such as transfer protocols, transfer reports, validation reports, and regulatory submissions, ensuring they are compliant with cGMP and regulatory requirements.


• Represent analytical function in project team meetings and work closely with cross-functional teams to meet project timelines and goals.


• Proven experience in managing relationships with external CMOs, ensuring quality and compliance, while driving performance.


• Excellent communication skills, with the ability to effectively collaborate with cross-functional teams, external partners, and regulatory agencies.

Your profile

• Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, Organic Chemistry or Medicinal Chemistry or related discipline with 5 years of relevant experience working in the Oral Solid Dosage (OSD), a Master's degree with 7 years of relevant experience, or a Bachelor's degree with 10 years of relevant experience.


• In-depth theoretical and extensive hands-on experience in HPLC/UHPLC, GC, MS, NMR, UV, ICP, dissolution, etc.


• Must be familiar with various solid dosage form analytical techniques such as dissolution, disintegration, PSD, FT-IR, XRD, SEM, optical microscopy etc.


• Proficient in regulatory requirements, including cGxP, CMC, ICH, and compendial standards (USP/EP/JP).


• Strong analytical and problem-solving skills, with the ability to apply statistical methods to process optimization and control and draw meaningful conclusions.


• Ability to work in a team-oriented environment that embraces change, risk, and flexibility is required.


• Good listening and writing skills in English and French.

Other relevant information

• Contract Duration: At least 2 years.


• Language: English, and French.


• Domestic and international travel up to 25%


• Position based in France with the possibility of teleworking (hybrid mode).

Profil souhaité

• Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, Organic Chemistry or Medicinal Chemistry or related discipline with 5 years of relevant experience working in the Oral Solid Dosage (OSD), a Master's degree with 7 years of relevant experience, or a Bachelor's degree with 10 years of relevant experience.


• In-depth theoretical and extensive hands-on experience in HPLC/UHPLC, GC, MS, NMR, UV, ICP, dissolution, etc.


• Must be familiar with various solid dosage form analytical techniques such as dissolution, disintegration, PSD, FT-IR, XRD, SEM, optical microscopy etc.


• Proficient in regulatory requirements, including cGxP, CMC, ICH, and compendial standards (USP/EP/JP).


• Strong analytical and problem-solving skills, with the ability to apply statistical methods to process optimization and control and draw meaningful conclusions.


• Ability to work in a team-oriented environment that embraces change, risk, and flexibility is required.


• Good listening and writing skills in English and French.

Lieu de la mission