The night shift Manufacturing Associate position (7p-7a 12hr Rotation) presents an opportunity for the qualified candidate to merge their leadership skills, technical knowledge of the operation, and general project management skills in a bulk manufacturing environment. Under general supervision, duties include:
• Comply with and reinforce cGMPs and safety requirements
• Apply process knowledge, scientific expertise, and compliance knowledge; and use analytical and troubleshooting skills to support manufacturing operations and drive continuous improvement
• Identify, recommend, and implement improvements related to operations for the area
• Troubleshoot complex automated systems and operations
• Participate on and/or potentially lead cross-functional project teams
• Support the development of new strategies related to operations for the area (e.g., Validation strategies, SOP revision strategies, etc.)
• Potentially Initiate, review, revise, and approve Manufacturing Batch reports, SOP’s, and other CGMP documents.
• Serve as Trackwise® record owner for non-conformances
Associate’s degree and 4 years of directly related experience
High school diploma / GED and 6 years of directly related experience
• Bachelor’s degree in Engineering or Life Sciences
• Technical understanding of cell culture operations and general biopharmaceutical production activities (e.g. perfusion, mammalian cell culture production, centrifuge operation, depth filtration, cell culture laboratory techniques (e.g. cell counting, microscopic examination, BGA, etc.), aseptic technique, depth filtration, CIP, SIP, and filter integrity testing).
• Skilled in performance of GMP production operations
• Ability to communicate effectively with technical staff and management
• Experience with investigations into manufacturing deviations and determination of potential manufacturing impact and root cause, and application of corrective actions
• Strong technical writing skills
Amgen - 11 months ago
Amgen is among the biggest of the biotech big'uns, and it's determined to get even bigger. The company uses cellular biology and medicinal...