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Our client is a big biopharmaceutical company. The company is focused on different cell therapies.
Role description
You will be responsible for working closely with Process Development teams to assure process reliability and robustness in preparation for comparability and process validation. Participating and supporting various FMEAs processes. You will participate in evaluation of new tech for introduction into GMP manufacturing. Participate and report a cross-functional development team to advance production activities.
Responsibilities
Ensure successful manufacturing process comparability and process validation runs
Write and review technical documentation (batch records, SOPs, protocols & reports for equipment qualifications, comparability, process and cell therapy manufacturing process validation testing)
Participate in evaluation of new technology and process automation for introduction into GMP manufacturing
Participate in laboratory experiments that support process development for extended process characterization, investigation resolution, and process improvements.
Requirements
Bachelor’s degree
Pharmaceutical experience – 3+ years preferred
CAPA/RCA experience
Working with Quality Systems experience
Tech transfer experience strongly preferred
Cell Therapy experience is considered a plus
Prosimy o aplikowanie poprzez przycisk znajdujący się po prawej stronie ogłoszenia.
Czy chcesz otrzymywać oferty pracy na podobne stanowiska?
