Senior Manufacturing Associate - Night Shifts

Role Summary

Senior Manufacturing Associate - Night Shifts. This role performs routine and non-routine manufacturing operations in Cell Culture, Purification, Solution & Equipment Prep areas, operates production equipment per SOPs for clinical and/or commercial products, and supports engineering and validation activities. Reports to Manufacturing Supervisor. Night shift: 6:00 p.m. – 6:00 a.m., rotating 2-2-3 schedule including every other weekend.

Responsibilities

• Carry out cGMP manufacturing operations utilizing SOPs, Batch Records and form preps.
• Troubleshoot and escalate process-related issues; create work orders; initiate and document minor deviations.
• Enter data in LIMS, MODA and other systems; request and execution of GMP documentation.
• Lead execution of critical, routine and non-routine production operations; inform management of events impacting schedule; review manufacturing documentation in real time to ensure compliance.
• Coordinate sample preparation and testing; propose and review document revisions; perform scheduled cleaning of equipment.
• Work safely; notify management of safety issues; participate in visual management and continuous improvement initiatives.
• Assemble/disassemble process equipment; standardize equipment; support changeover activities; execute equipment and process qualifications and validation.
• Act as subject matter expert for improvement projects; provide technical training; maintain training requirements; develop personal development plan; provide annual performance self-assessment.

Qualifications

• High school diploma and 4+ years of experience or Associate's Degree in Life Sciences/Engineering with 3 years of GMP Manufacturing experience.
• Biotech Certificate ideal.
• Strong understanding of general and detailed job aspects and practical applications.
• Proficient at following written instructions (Batch Records, Form Preps, Technical Protocols, Procedures).
• Full awareness of current Good Manufacturing Practices; proficient computer skills; proficient in aseptic technique.
• Ability to work cohesively in a team; experience with systems such as LIMS, MODA and other business systems.

Skills

• Aseptic technique
• Computer skills
• Teamwork
• Documentation and compliance

Education

• High school diploma or Associate's Degree in Life Sciences/Engineering (or equivalent experience)

Additional Requirements

• Willingness to work nights, weekends, and overtime as needed; ability to stand for extended periods; ability to lift 25-50 lbs; ability to gown and work in controlled environments; use of PPE; ability to work around chemicals; essential personnel in inclement weather as required.