Manufacturing Associate Upstream
Avid Bioservices
Summary
The Manufacturing Associate Upstream performs multiple aspects of cGMP contract cell culture manufacturing in a multi-product manufacturing facility, including production, documentation, writing reports, requesting and purchasing materials, and scheduling equipment services and calibrations. The Manufacturing Associate will play an integral role in ensuring the production and on-time release of quality products.
Job description
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 through cell culture expansion and maintenance up to 15L spinner flasks performed in a BSC)
- Operate and maintain equipment including 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
- Help create and actively support 5S, Area Improvement, and Safety Team initiatives
- 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 equipment and material are available as required for each production run
- Assist in the transfer of technology from PD and MSAT to cGMP Manufacturing
- Assist with periodic technical and compliance investigations, inspections, and audits
- Prepare media and buffer
- Perform 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 Monday through Friday on a 5x8 (5 days x 8 hours) schedule, with operating hours from 8:00am to 5:00pm. Must be available to work overtime, weekends, and/or holidays if needed.
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
- Strong written and verbal communication skills
- Exceptional multitasking skills
- Unparalleled attention to detail
- Team player with positive attitude
- Ability to build relationships with team members, clients, vendors, and suppliers
- Ability to lift objects up to 20 pounds occasionally
- Visual acuity including close, distance, and color vision
Benefits
- Health Insurance
- Dental Insurance
- Vision Insurance
- 401(k) Matching
- Paid Time Off
- Performance-Based Bonuses
- Career Growth and Development
Company overview
Avid Bioservices is a leading contract development and manufacturing organization (CDMO) specializing in biologics derived from mammalian cell culture systems. Founded in 1993 and headquartered in Tustin, California, the company has over 30 years of experience in biologics manufacturing. Avid provides comprehensive process development, CGMP clinical and commercial manufacturing services for the biotechnology and biopharmaceutical industries. Their expertise spans from early-stage process development to full-scale commercial manufacturing, including cell line development, upstream and downstream optimization, analytical methods development, and regulatory submissions support. The company has produced more than 250 commercial batches and has five commercial products marketed in over 90 countries. With state-of-the-art facilities and a flawless quality track record maintained for over a decade, Avid Bioservices focuses on transforming the CDMO experience through personalized processes, unrivaled expertise, and exceptional quality standards. The company was recently acquired by GHO Capital Partners and Ampersand Capital Partners in a $1.1 billion transaction, positioning it for continued growth in the biologics manufacturing sector.