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Biomanufacturing Associate (Upstream Cell Culture)

Avid Bioservices
Tustin, CA
  • Posted: over a month ago
  • Full-Time
Job Description

At Avid we are dedicated to the improvement of global patient outcomes by delivering world-class services. Our expertise enables us to partner with our customers to advance their products from clinical development to commercial launch. Do you possess the skills and expertise below to improve patient lives and support patient innovative therapies? If so, apply today!

Summary/Objective:

The Manufacturing Associate 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.

Essential Duties and Responsibilities include the following; other duties may be assigned:

(Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.)

  • Operate and maintain cell culture bioreactors (100L - 2000L stainless steel and disposable STR/SUB) in batch, fed-batch, and perfusion modes
  • Perform equipment cleaning and sterilization manual cleaning, clean in place (CIP), pressure test (PT), and steam in place (SIP)
  • Responsible for cell culture expansions and aseptic techniques (thaw cell banks -1mL vial through cell culture expansion and maintenance - up to 36L 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, and CIP skid
  • Harvest operations - pod filtration and TFF system
  • 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
  • Revise and initiate Batch Production Records (BPRs), Standard Operating Procedures (SOPs), and forms using cGMP Documentation
  • 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 Technical Operations (MTO), Manufacturing Quality Sciences (MQS) 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 to cGMP Manufacturing.
  • Assist with periodic technical and compliance investigations, inspections, and audits.
  • Operate and maintain Getinge Autoclave and Gruenberg Oven.
  • Prepare glassware and equipment, media and buffer and perform aseptic filling and daily monitoring of equipment for production.

Education and Experience:

  • Science-Related Bachelor's degree (i.e. Biology, Biotechnology, Chemical Engineering) for the Associate level.
  • Biotech industry experience is required with 2+ years cGMP mammalian and/or fermentation cell culture experience at the Associate level.
  • Professional experience working for a contract manufacturing organization (CMO) in the life sciences field is preferred.
  • Proficient in personal computer skills, including e-mail, record keeping, routine database activity, word processing, spreadsheets, and graphics.
  • Ability to handle and prioritize multiple tasks and projects simultaneously.
  • Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
  • Ability to write routine reports and correspondence.
  • Ability to speak effectively before groups of customers or employees of organization.
  • Must be able to gown for a class 10,000 cleanroom environment and work under aseptic conditions in a class 100 environment (BSC and LAF).

Work Schedule and Hours:

This role is a full-time, non-exempt position. Due to manufacturing operations, this role requires flexible working hours.

  • Work overtime and weekends as necessary
  • Perform shift work Sun - Wed or Wed - Sat (4 days x 10 hours)
  • The M-F 3pm-12am Swing Shift may also be available for this role, inquire within

Employee Benefits:

  • Medical, Dental, Vision, Life, and Long-Term Disability Insurance
  • 401(K) Plan
  • Employee Stock Purchase Plan (ESPP)
  • 15 Days PTO and 12 Designated Holidays per year
  • Tuition Reimbursement Program
  • And more! Check out our Total Rewards package at https://avidbio.com/careers/

EQUAL OPPORTUNITY/AFFIRMATIVE ACTION EMPLOYER

Avid Bioservices does not discriminate against any employee or applicant for employment because of race, color, religion, sex, national origin, age, marital status, genetic information, disability or protected veteran status.



Job Posted by ApplicantPro

Avid Bioservices

Address

Tustin, CA
92780 USA

Industry

Manufacturing

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