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- 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 regulations
- Proactive, results-oriented, self-starter with experience in a complex manufacturing environment
- Demonstrated 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
Senior Cell Manufacturing Associate - Philadelphia, United States - Proclinical
Description
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: