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In-Process Analyst, Quality Control (Flex Team)

Company: Peregrine Pharmaceuticals, Inc.
Location: Tustin
Posted on: June 8, 2021

Job Description:

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!


The Quality Control Analyst will perform testing and sampling to support manufacturing, validation, process development and stability studies in a GMP environment for the QC In-Process team.

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

  • Perform basic compendial test methods without supervision and with strict adherence to written protocols, analyze data and report results
  • Formulate buffers and reagents for the purpose of performing test methods
  • Write and revise test methods and procedures
  • Perform aseptic sampling.
  • Perform the following testing: visual inspection, pH, conductivity, osmolality, spectrophotometry, endotoxin by LAL and HPLC.
  • Perform water testing and raw material sampling and testing
  • Perform QC testing for lot release, stability, development/validation projects, and investigations
  • Other functions include writing study protocols and reports
  • Work with other departments in developing, revising and implementing QC procedures and policies
  • Should be aware of company cGMPs as well as industry regulations that apply to all job functions
  • Perform sample pick up and sample locating without supervision and with strict adherence to written protocols

Position Type/Expected Hours of Work:

This role is a full-time, non-exempt position. Our "Flex Force" team will work a 5 day a week schedule initially from 8am-5pm and after 4-6 months of training, the team will transition to working 3pm-midnight. Because of the flexibility and important training, the individuals in this team will have the opportunity to move to our 4-day a week, 10-hour shift if they desire as openings arise.

Required Qualifications:

  • BS degree in Biochemistry, Chemistry, Biology or a related field and 2-4 years of biotech industry experience working in a QC or analytical lab.
  • Must have experience with analytical testing, writing reports, GMPs, and regulatory audits.
  • Candidate should also have experience with most if not all of the methodologies listed above.
  • Experience with basic maintenance and troubleshooting of analytical instrumentation is highly desirable.


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.

Keywords: Peregrine Pharmaceuticals, Inc., Tustin , In-Process Analyst, Quality Control (Flex Team), Other , Tustin, California

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