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Lead Aseptic Manufacturing Specialist
2 months ago
As a pivotal contributor to the autologous cell therapy production initiative, candidates should possess a robust background in cell culture, aseptic practices, and ISO class 5 cleanroom operations.
Key Responsibilities
- Achieve a Subject Matter Expert (SME) level of proficiency in executing and troubleshooting GMP cell therapy manufacturing processes.
- Participate in training sessions and ensure that all training documentation is accurately maintained.
- Adhere to quality standards and requirements as outlined in documentation.
- Assist with operational support tasks including inventory management, kit assembly, reagent preparation, room readiness, sanitation tasks, and equipment upkeep.
- Conduct document reviews, including completed Batch Records and Logbooks.
- Aseptic Manufacturing Specialists are expected to adhere to their assigned schedules. Initial onboarding training will occur during standard weekday hours; however, post-training, shifts may include weekends, evenings, and holidays as necessary. Overtime may also be required.
- Support documentation efforts, which may involve drafting and approving SOPs, Batch Records, Deviations, CAPAs, etc. Make necessary revisions to ensure procedures are accurately represented.
- Implement documentation Change Controls for SOPs, Batch Records, etc., as required.
Preferred Qualifications
- At least 2 years of experience in biopharmaceutical GMP manufacturing operations, with a focus on cell culture and downstream processing.
- Ability to maintain clarity of vision at various distances, depth perception, and color differentiation. A visual examination may be conducted to assess visual acuity and color perception.
- Strong quality orientation, familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulations.
- Self-motivated, results-driven individual with experience in a complex manufacturing environment.
- Willingness to travel up to 5% based on business needs.
R&D Partners is a national staffing firm specializing in Scientific, Clinical Research, and Engineering sectors. Our team boasts over 200 years of combined staffing expertise, offering consulting, direct hire, and outsourcing solutions.
The foundation of our success lies in our knowledgeable and experienced recruiting team. Our specialized recruiters in life sciences, clinical research, and engineering conduct thorough assessments of client needs to identify suitable candidates through our extensive professional network. R&D Partners adopts a proactive recruiting approach, fostering relationships with experienced candidates to align their talents with client opportunities when the time is right.
