Avid Bioservices
  • 17-Sep-2018 to 31-Oct-2018 (PST)
  • CDMO - Manufacturing Quality Sciences
  • 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.

This is a unique promotional opportunity for professionals with both quality assurance and manufacturing experience dealing with tech transfers, mammalian cell cultures and batch records. If you are currently in Quality Assurance with a manufacturing background and are looking to take the next step in your career to provide innovate solutions to the technical field of Manufacturing Quality Sciences, apply here!

Summary/Objective:

  • The Specialist, Manufacturing Quality Sciences will assist in the technical transfer of process from client (s) and/or Process Sciences to Manufacturing scale. Responsible for continuous process improvement in manufactured products.
  • Where issues or improvements are identified, this role will propose viable solutions including a final product impact assessment. Will identify elements that can be made more efficient, are potential sources of discrepancies, require 'fine-tuning', or need a complete revision.  
  • Review discrepancies, assist investigation activities and prepare a CAPA as appropriate. Propose innovative methods/procedures for gap analysis and reduction of deviations.
  • Will prepare written reports and presentations for meetings as assigned.
  • Review 'Engineering Run' Batch Records prior to final QA review and approval.

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

  • Function as SME on the production floor for both Upstream and Downstream operations
  • Actively assist in the technology transfer from Process Science (PS) to cGMP Manufacturing.
  • Assist in the design and execution of studies to support MFG production.
  • Perform gap analyses on tech transfers.
  • Write technical risk assessments.
  • Identify and implement efficiencies for manufacturing processes.
  • Ability to quickly identify process issues and resolve them expeditiously
  • Ability to perform sound root cause investigations and identify correct CAPAs
  • Review batch production records for engineering runs

Supervision Received:

General supervision: routine duties are performed with minimal supervision; standard practices or procedures allow analyst to proceed alone at routine work; work is reviewed upon completion.

Position Type/Expected Hours of Work:

This role is a full-time position with flexible scheduling due to operations/scheduling. General days and hours of work are Monday through Friday 8:00am to 5:00pm, unless otherwise stated by Supervisor. The incumbent may be required to work weekends as necessary.

Education and/or Experience:

  • A Bachelor's degree in life sciences or engineering or higher is required.
  • Biopharmaceutical experience is required - the incumbent may possess 2 to 3 years in technical experience in industry or in graduate level studies, or equivalent combination of education and experience.
  • Minimum of 2 - 3 years' experience working with biologics purification.
  • Ability to think creatively to address complex problems.
  • Ability to understand basic cell culture, bioreactor, chromatography theory, viral filtration, and ultrafiltration and be able to apply it to real-time scenarios.
  • Proficient in personal computer skills, including e-mail, record keeping, routine database activity, word processing, spreadsheets, and graphics.
  • Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
  • Ability to write technical reports and correspondence.      
  • Ability to speak effectively before groups of customers or employees of organization. 

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.

Avid Bioservices
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