Senior Cell Manufacturing Associate

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 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) 215-531-6914 or s.briggs@proclinical.com.

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