Manufacturing Associate Upstream (M-F 2nd Shift)

About the role

The Manufacturing Associate Upstream plays a crucial role in the production and on-time release of quality biopharmaceutical products. They are responsible for various aspects of cGMP contract cell culture manufacturing, including production, documentation, and equipment operation.

Responsibilities

• Conduct investigations to determine root causes and implement corrective/preventative actions for facilities and equipment issues.
• Operate and maintain cell culture bioreactors (Wave and 100L – 2000L disposable STR/SUB).
• Perform daily monitoring of equipment and conduct aseptic techniques such as thawing cell banks, expanding cultures, and using aseptic techniques.
• Operate and maintain equipment including NOVA analyzers, pH meters, CO2 analyzers, pH and DO simulators, microscopes, pipettors, Vi-Cell cell counters, balances, scales, MFCS, Rees, and Delta V.
• Harvest operations involve pod filtration, 3M filtration, and TFF systems.
• Schedule vendor service appointments and purchase necessary equipment and materials.
• Support 5S, Area Improvement, and Safety Team initiatives to foster a continuous improvement culture.
• Operate Sartocheck filter integrity testers and maintain cleanroom facilities and equipment.
• Revise and initiate Batch Production Records (BPRs), Standard Operating Procedures (SOPs), and forms.
• Collaborate with other departments for raw materials, water, testing requirements, documentation, validation, maintenance, and scheduling.
• Identify, escalate, and report deviations (IRs/DRs/CAPAs).
• Assist in the transfer of technology from PD and MSAT to cGMP Manufacturing.
• Participate in technical and compliance investigations, inspections, and audits.
• Report unsafe activities to manager and/or Human Resources.
• Communicate with team members, supervisors, and members of other departments to resolve problems promptly.
• Prepare media and buffers and perform aseptic filling.

Requirements

• 2+ years of related experience and/or training; or equivalent combination of education and experience.
• 2+ years of industry experience working with mammalian cell culture.

Preferred Qualifications

• Bachelor’s or associate degree with a preference for biology or chemistry emphasis.

Position Type/Expected Hours of Work

This role is a full-time position operating Monday through Friday on a 5x8 (5 days x 8 hours) schedule, with operating hours from 5:00PM to 2:00AM. Must be available to work overtime, weekends, and/or holidays if needed.

Compensation

We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off. The compensation range for this role is $20.52-$27.35 hourly depending on experience and qualifications.

Physical Demands & Work Environment

In this dynamic role, expect a blend of regular activities like sitting, standing, and walking, with occasional physically engaging tasks such as lifting objects up to 20 pounds. The work environment might expose you to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally. However, reasonable accommodations are available to enable individuals with different abilities to perform effectively, ensuring a supportive and adaptable work setting.