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Formulation Process Development Engineer

Location: Jacou (France)

joel.richard@medincell.com

MedinCell
Technical & Pharmaceutical Operations

We are seeking a Formulation Process Development Engineer based in our Jacou facility close to Montpellier to participate in our ongoing success as a  fast-growing, socially responsible company dedicated to Global Health.  As a Formulation Process Development Engineer, you will play a pivotal role in the process development and optimization of technology transfer lifecycle for injectable formulations to Contract Manufacturing Organizations (CMOs).

Responsibilities:

Design, lead and implement tech transfer, scale up and optimization of formulation process operations
Ensure optimal communication between CMOs and internal functions to ensure that all requirements are met against defined project plans and delivery milestones for process transfer and manufacturing of GMP batches
Lead the preparation of transfer and manufacturing documentation (transfer protocol and reports, Master Batch Records, ) and supervise the execution at CMOs
Prepare and execute up-scaling and process validation trials
Propose and implement process optimization at CMOs. Confirm or adjust the design space of the formulation process identified during development
Define optimal manufacturing strategy (sterile manufacturing or post-sterilization) and implement post-sterilization techniques if needed
Develop and validate a robust and continually improved process in compliance with GMP requirements
Keep formulation process development knowledge at the highest level through scientific/technical literature survey to solve issues, provide an efficient trouble-shooting support and make recommendations for process improvement
Participate in customer/partner meetings to bring process development knowledge and support when required
Work according to established SOPs and Quality standards. Actively contribute to Quality System improvement and procedure updating as regards process transfer and scale-up, and manufacturing of GMP batches.
Experience / Education:

Ideal: Pharmacist (Industry specialization) with Process Development Engineer degree – Minimum: Master II degree in Chemical or Pharmaceutical Engineering
Experience: Minimum 3 years in Formulation Process transfer and scale-up of (sterile) injectable formulations
Transnational/international educational or work experience
Experience working in an international team or with international clients preferred
General work attitude

Effective functioning in a rapidly changing environment and adherence to the values, principles, and mission of the company
Consistency, precision, perseverance, listening skills
Openness and ability to adapt to changing situations
Excellent interpersonal skills and ability to work with others in a highly collaborative, team-work environment
Innovative and creative attitude; problem-solving ability

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 PhD student position within the research topic “Development of peptide drug delivery system in vitro to tumor cells transfection”.

 Center for Interdisciplinary Research on Medicine (CIRM), Liège University

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Offre d’emploi : Chargé de projet en formulation

Type de contrat : CDI

Niveau de salaire : à négocier

Lieu de travail : Faculté de Pharmacie, Châtenay-Malabry, 92290, France

Date limite de candidature : 24 Février 2017

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