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Sr. Research Associate, Analytical Development

Company: Avid Bioservices
Location: Tustin
Posted on: November 17, 2022

Job Description:

Avid Bioservices Inc., headquartered in Tustin CA, is a dedicated contract development and manufacturing organization ("CDMO") focused on development and CGMP manufacturing of biopharmaceuticals products derived from mammalian cell culture and viral vectors. Avid provides a comprehensive range of process development, high quality CGMP clinical and commercial manufacturing services for the biotechnology and biopharmaceutical industries. With over 29 years of experience producing monoclonal antibodies, enzymes, and recombinant proteins in batch, fed-batch, and perfusion modes, Avid's services include CGMP clinical and commercial drug substance manufacturing, purification, release and stability testing as well as regulatory strategy, submission and support. Avid also provides a variety of process development activities, including 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!In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.Covid-19 Hiring Update: We are continuing to interview and hire during this time. Avid Bioservices' is committed to caring for the safety and well-being of applicants and employees; all interviews will be completed over the phone or virtually.Summary/Objective:The Analytical team is seeking an experienced Sr. Research Associate ("RA") who is interested in pursuing a career in developing protein biologics. The primary focus of the Sr. RA will be to develop Cell-based, ELISA, HPLC, and/or LC-MS methods. The incumbent will work under the guidance of analytical scientists and with process development scientists to identify and characterize protein biologics. This position will interface with the Quality Control testing group as methods are transferred into that group for cGMP testing and may interface with external clients.Essential Duties and Responsibilities include the following; other duties may be assigned:

  • Perform and review routine wet chemistry/raw material assays and ELISA/cell-based immunoassays, electrophoresis (SDS-PAGE/IEF) and HPLC.
  • Perform aseptic sampling, visual inspection, gowning and working in clean room areas.
  • May train/supervise the experimental work of more junior analysts and may be a member of interdepartmental/tech transfer teams.
  • Develop, review, revise and write test methods, standard operating procedures and may perform trending analysis.
  • May be designated as study lead for validation projects, investigations and method development projects.
  • Previous experience in either HPLC/CE or Potency/ELISA assay methodologies is required.
  • Knowledgeable of company cGMPs as well as industry regulations that apply to job functions. Participates in regulatory inspections.
  • Support continuous improvement initiatives.Required Education and Experience:
    • At least a Bachelor's of Science degree in the Biological or Physical Sciences, preferably Biochemistry, Chemistry, Biology.
    • 4-6 years industry experience working in a QC or Analytical lab (with a BS degree) or2-4 years industry experience working in a QC or Analytical lab (with a MS degree)
    • Analytical testing and equipment utilizing analytical biochemistry methods
    • Writing reports/procedures/specifications
    • GMPs and regulatory audits
    • Potency/ELISA and/or HPLC experience is essential.
    • Should also have experience with most if not all of the following: protein characterization, electrophoresis, chromatography, aseptic techniques, cell culture, LAL and assay validation/qualification.
    • Experience with Octet, liquid handler and Maurice a plus.Work Schedule and Hours:Any scientific staff member can expect to work overtime, including during the weekends. Off-site meetings with clients and regulatory agencies are a usual occurrence.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.

      Job Posted by ApplicantPro

Keywords: Avid Bioservices, Tustin , Sr. Research Associate, Analytical Development, Other , Tustin, California

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