Manufacturing Associate Upstream (Sunday to Wednesday)

Avid Bioservices•Tustin, CA

17h•Onsite

About The Position

Avid Bioservices is seeking a Manufacturing Associate Upstream to perform multiple aspects of cGMP contract cell culture manufacturing in a multi-product manufacturing facility. This role involves production, documentation, writing reports, requesting and purchasing materials, and scheduling equipment services and calibrations. The Manufacturing Associate will be integral in ensuring the production and on-time release of quality products, embodying the company's core values of Integrity, Adaptability, Innovation, Teamwork, and Passion to improve patients' lives by consistently delivering high-quality biopharmaceutical products. The role includes leading and conducting investigations, performing daily equipment monitoring, operating and maintaining cell culture bioreactors, conducting cell culture expansions with aseptic techniques, operating and maintaining various equipment, performing harvest operations, scheduling vendor service appointments, purchasing necessary equipment and materials, supporting continuous improvement initiatives, maintaining cleanroom facilities, performing cGMP documentation, revising and initiating Batch Production Records (BPRs), Standard Operating Procedures (SOPs), and forms, collaborating with other departments, identifying and reporting deviations, setting up new manufacturing processes and equipment, troubleshooting equipment and process issues, ensuring equipment and material availability, identifying technical and procedural issues, assisting in technology transfer, assisting with investigations and audits, reporting unsafe activities, participating in team efforts, and communicating effectively with team members and other departments. The role also involves preparing media and buffer, performing aseptic filling, and other assigned duties.

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.

Nice To Haves

Bachelor's or associate degree (A.A.) with a preference for biology or chemistry emphasis.

Responsibilities

Performs multiple aspects of cGMP contract cell culture manufacturing in a multi-product manufacturing facility.
Conducts him/herself in a manner representing the core values (Integrity, Adaptability, Innovation, Teamwork, and Passion) of the company.
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.