Job Description:
Within the Drug Substance Development (DSD) - Manufacturing department, we are seeking a highly skilled USP Manufacturing Associate Scientist to support large-scale operations in GMP and pilot environments.
This role offers an exciting opportunity to join a team of experienced technicians, engineers, and scientists specializing in the production and purification of recombinant proteins derived from animal cells.
The successful candidate will be responsible for supporting USP activities from both operational and documentation perspectives, encompassing cell expansion, bioreactor processes in fed-batch/perfusion, and tech transfer scaling-up.
We are looking for an individual who can perform various tasks efficiently, including:
* Executing operational USP activities
* Facilitating the transfer of USP operations to new sites
* Analyzing data and presenting findings to stakeholders, including QC, QA, and project managers
* Preparing accurate documentation, such as protocols, reports, and procedures
* Participating in maintaining laboratory/clean room functionality
* Supporting compliance activities, including deviations, CCPs, and investigations
* Contributing to continuous improvement initiatives by proposing and implementing projects
* Assisting with equipment qualification and validation during process changes or start-ups
Requirements:
To be successful in this role, you should possess:
- A technician diploma (CFC, HES, BTS, IUT...) with 5 years' experience in USP or an equivalent Engineering/ Master's degree in biochemistry/biology/biotechnology
- Excellent English and French language skills (written and reading comprehension)
- In-depth knowledge of USP processes and BPF, GLP, and/or GMP principles
- Familiarity with IT tools, such as Pack Office, Trackwise/SAP, DeltaV, MES, and LIMS
- Strong communication and teamwork skills, with the ability to interact effectively with various stakeholders
- Ideally, experience in pharmaceutical production (USP development, clinical, and commercial)
- Training in Operational Excellence (LEAN, BELT) is a plus