Manufacturing Associate Upstream

Key Responsibilities

• Perform daily monitoring of equipment.
• Operate and maintain cell culture bioreactors (Wave and 100L – 2000L disposable STR/SUB) in batch, fed-batch, and perfusion modes.
• Responsible for cell culture expansions and aseptic techniques (thaw cell banks -1mL vial through cell culture expansion and maintenance - up to 15L spinner flasks performed in a BSC).
• Operate and maintain equipment - NOVA analyzers, pH meters, CO2 analyzers, pH and DO simulators, microscope, pipettors, Vi-Cell cell counter, balance, scale, MFCS, Rees, and Delta V.
• Harvest operations - pod filtration, 3M filtration, and TFF system.
• Schedule vendor service appointments for equipment.
• Purchase necessary equipment and associated materials that are needed or low in supply.
• Help create and actively support 5S, Area Improvement, and Safety Team initiatives to ensure a Continuous Improvement culture throughout the department.
• Operate Sartocheck filter integrity testers.
• Maintain cleanroom facility and equipment.
• cGMP Documentation.
• 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).
• Set up critical new manufacturing processes and equipment.
• Troubleshoot equipment and process issues in collaboration with Facilities (FAC), Manufacturing Sciences and Technology (MSAT), and Validation (VAL) departments.
• Ensure that equipment and material are available as required for each production run.
• Identify the technical, procedural, and equipment issues that hinder production and compliance. Inform support departments and manager as needed.
• Assist in the transfer of technology from PD and MSAT to cGMP Manufacturing.
• Aid in periodic technical and compliance investigations, inspections, and audits.
• Report all unsafe activities to manager and/or Human Resources.
• Communicate with team members, supervisors, and members of other departments, as appropriate, to assure prompt resolution of problems.
• Prepare media and buffer.
• Aseptic filling.

Minimum Qualifications

• 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 (A.A.) with a preference for biology or chemistry emphasis.

Position Type/Expected Hours of Work

This role is a full-time position operating Sunday through Wednesday on a 4x10 (4 days x 10 hours) schedule, with operating hours from 7:00am to 6:00pm. During the initial training period, working days and hours will be Monday through Friday 7:00am to 4:00pm.

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 $21.52 - $26.92 per hour depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.

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 25 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.