Biomanufacturing Associate (Upstream)

Avid Bioservices - Tustin, CA2.3

Full-timeEstimated: $56,000 - $79,000 a year
EducationSkills
Avid Bioservices is a dedicated contract development and manufacturing organization CDMO focused on development and cGMP manufacturing of biopharmaceutical products derived from mammalian cell culture. We provide a comprehensive range of process development, high quality cGMP clinical and commercial manufacturing services for the biotechnology and biopharmaceutical industries. With 25 years of experience producing monoclonal antibodies and recombinant proteins in batch, fed-batch and perfusion modes, our services include cGMP clinical and commercial product manufacturing, purification, bulk packaging, stability testing and regulatory strategy, submission and support. We also provide a variety of process development activities, including cell line development and optimization, cell culture and feed optimization, analytical methods development and product characterization.

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 to include a minimum of two to four 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

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 because he or she is a protected veteran.