Senior Manufacturing Associate - Nights

Role Summary

Senior Manufacturing Associate – Nights. Perform manufacturing operations in Cell Culture, Purification, Solution & Equipment Prep areas, operating production equipment according to SOPs for clinical and/or commercial products. Support engineering and validation activities. Report to Manufacturing Supervisor.

Responsibilities

• Perform cGMP manufacturing operations using SOPs, Batch Records, and Form Preps; troubleshoot and escalate process issues, execute production operations, and review documentation in real time to ensure compliance.
• Initiate and document minor deviations, create and request GMP documentation and work orders as needed.
• Enter data in systems such as LIMS, MODA, and other business tools; coordinate sample preparation and testing.
• Propose and review document revisions; inform management of events impacting schedules and escalate safety issues or risks.
• Participate in tiered visual management and support continuous improvement initiatives.
• Manage equipment and facility-related projects, including cleaning, assembly/disassembly, standardization, changeovers, and qualification/validation activities.
• Act as a subject matter expert on improvement projects and provide technical training; contribute to training material development and maintain training requirements.
• Develop and maintain a personal development plan, and complete an annual performance self-assessment.

Qualifications

• Normally requires a high school diploma and 4+ years of experience or an Associate's Degree in Life Sciences/Engineering field with 3 years of GMP Manufacturing experience.
• Biotech Certificate would be Ideal.
• Experience with the general and detailed aspects of the job, and their practical applications to problems and situations ordinarily encountered.
• Will perform as a subject matter expert for equipment and/or systems.
• You are proficient at following written instruction in the form of Batch Records, Form Preps, Technical Protocols and Procedures.

Skills

• Proficiency in following written manufacturing instructions and quality systems.
• Technical training and ability to develop training materials and maintain training requirements.
• Strong documentation and data entry capabilities in manufacturing environments.

Education

• High school diploma or equivalent with 4+ years of GMP Manufacturing experience, or an Associate's Degree in Life Sciences/Engineering with 3 years of GMP Manufacturing experience.

Additional Requirements

• Work in controlled, gowning-required environments; wear protective clothing as needed.
• Work in cold, wet environments; lift/push equipment up to 25–50 lbs; stand for extended periods; climb ladders; and work around chemicals with potential respiratory protection.
• Ability to work multiple shifts, including weekends, or supplemental hours as necessary; flexibility to production schedule.