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Performs cGMP upstream biopharmaceutical manufacturing, including mammalian cell culture expansion, bioreactor operation, aseptic processing, harvest and filtration. Maintains equipment, prepares media and buffers, documents production, supports investigations, deviations, CAPAs, process transfers, audits, and continuous improvement. Coordinates equipment services, materials purchasing, and cross-functional resolution of technical and compliance issues while ensuring production readiness and on-time product release.
Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes.
Your Role:
The Manufacturing Associate Upstream performs multiple aspects of cGMP contract cell culture manufacturing in a multi-product manufacturing facility, including, but not limited to 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. The Manufacturing Associate will conduct him/herself in a manner representing the core values (Integrity, Adaptability, Innovation, Teamwork, and Passion) of the company with the common purpose of improving patients’ lives by consistently delivering high-quality biopharmaceutical products. Lead and conduct investigations as they pertain to facilities (or other areas of operations involving equipment or utilities) to determine roots causes and corrective/preventative actions.
- 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.
- Assist with periodic technical and compliance investigations, inspections, and audits.
- Report all unsafe activities to manager and/or Human Resources.
- Participate in proactive team efforts to achieve departmental and company goals.
- Communicate with team members, supervisors, and members of other departments, as appropriate, to assure prompt resolution of problems.
- Prepare media and buffer.
- Perform aseptic filling.
- Other duties may be assigned.
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 with a Wednesday through Saturday schedule, working 4 days a week and 10 hours each day (4 days x 10 hours), 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 hourly depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.
Who you are:
- You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.
- Your written and verbal skills are out of this world, and you communicate with clarity and confidence.
- You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything.
- You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.
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. Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day-to-day demands of this position.
Avid Bioservices Tustin, California, USA Office
14191 Myford Rd, Tustin, California, United States, 92780 7020
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