Avid Bioservices
  • 17-Sep-2018 to 31-Oct-2018 (PST)
  • Manufacturing
  • CA, USA
  • Full Time

Medical & Dental Insurance, 15 days PTO per year, 8 company holidays, 4 floating holidays, 401k with company match, lunch and learns, annual wellness day and ESPP


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 Specialist, Manufacturing supports the manufacturing operations team as a resource for reviewing completed formulation and operational batch production records for submission to Quality Assurance. The incumbent will have excellent time management skills to work in a fast-paced and dynamic work environment. The incumbent will be required to ensure formulation and operation GMP documentation are reviewed for good documentation practices and adhere to established quality standards and regulatory guidelines. In addition, the incumbent is responsible for improving manufacturing formulation and operational document submission processes to improve efficiencies for lot disposition and release, reduce cost, and increase customer satisfaction.

Technical Duties/Responsibilities & Essential Functions: (Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.)

  • Collaborate with internal and external customers to prioritize GMP document review schedule
  • Coordinate scheduling of formulation in-process sample testing with cross-functional organizations to ensure timely receipt of results for formulation release
  • Facilitate submission of reviewed formulation BPRs with Quality Assurance and coordinate release of formulations for production use
  • Facilitate and coordinate submission of reviewed operation BPRs with Quality Assurance to ensure lot disposition and release timelines are maintained
  • Perform real-time review of in-progress formulation and operation BPRs within the GMP production suites
  • Must be able to fully gown into ISO 8 (Class 100K) and ISO 7 (Class 10K) GMP production suites to perform real-time review of BPRs

Supervision Received:

The Manufacturing Specialist receives minimal supervision from the Sr. Manufacturing Manager and/or area supervisor/manager and may perform routine duties with minimal supervision.

Position Type/Expected Hours of Work:

This role is a full-time exempt position with flexible scheduling due to operations/scheduling. The incumbent may be required to work weekends as necessary.

Education and/or Experience: 

  • A Bachelor's degree in life sciences or engineering is required.
  • Biopharmaceutical experience is required - the incumbent may possess 3 to 5 years technical experience in industry or in graduate level studies. 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 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.
  • The successful incumbent is meticulous and detail oriented.

 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.

Avid Bioservices
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