Senior Cell Manufacturing Associate

4 weeks ago


Philadelphia, Pennsylvania, United States Proclinical Full time

Senior Cell Manufacturing Associate - Contract - Onsite

Proclinical Staffing is seeking a Senior Cell Manufacturing Associate to join a cutting-edge biotech company. This is a contract role located in Philadelphia, PA.

Skills & Requirements:

Bachelor's degree or some post-secondary education.3+ years of experience in biopharmaceutical based GMP manufacturing operations, including experience in cell culture and associated downstream processing.Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulationsProactive, results-oriented, self-starter with experience in a complex manufacturing environmentDemonstrated technical knowledge of aseptic processing in cleanroom environments is a must.Ability to mentor and provide best practices to other team members.Must be able to work with ambiguity - ready to change gears and plans quickly and manage constant change.Proficient with computers and Microsoft (Excel, Word, Outlook) programs.The Senior Cell Manufacturing Associate will:Develop a Subject Matter Expert (SME)-level understanding of GMP cell therapy manufacturing process(es).Assists with identifying training needs, and establishing a feedback loop to ensure continuous improvement.Deliver training sessions and ensure training documentation is maintained.Understand and comply with quality standards and requirements as documented.Ensure training schedules meet company production and quality targets.Provide operational support functions, including materials stocking and transfer, kit preparation, reagent preparation, room readiness, cleaning activities, and equipment maintenance.Perform document review, including executed Batch Records and Logbooks.Support documentation needs, including drafting and approval of SOPs, Batch Records, Deviations, CAPAs, etc. Perform basic revisions as needed to reflect current procedures accurately.Execute documentation Change Controls of SOPs, Batch records, etc., as needed.Support interdepartmental and departmental projects in a contributor capacity.Supports technical transfer and additional research-level testing activities as needed.May work on moderately complex assignments, requiring judgment to resolve operational issues without negatively impacting manufacturing efforts.Adhere to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), including Good Documentation Practices (GDP).Completes recording of data to comply with regulatory requirements.Attend or hold the daily huddle meeting and escalates issues/concerns at that forum to Area Management for further investigation.Compensation:

$35 hourly

If you are having difficulty in applying or if you have any questions, please contact Shannon Briggs at (+1) or

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

INDSCIC



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