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Manufacturing Associate III (Upstream)

Employer
Polaris Pharmaceuticals, Inc
Location
Vacaville, California
Start date
Jul 18, 2022

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Job Details

Role Title                       Manufacturing Associate III - Upstream

Department                   Manufacturing  

Supervisor                    Director of Manufacturing

FLSA                             Exempt

CORE VALUES 

 

Respect ● Passion ● Teamwork ● Integrity ● Honesty ● Commitment ● Collaboration

FUNCTION SUMMARY      Manufacturing Associate III - Upstream

The Manufacturing Associate III (Upstream) is responsible to support and participate in the manufacturing of drug products and intermediates following approved procedures while complying with cGMP and GDP. The Manufacturing Associate III is expected to understand site quality systems and production processes to support drug product manufacturing and perform role responsibilities. This person is expected to don coveralls, and qualify for aseptic gowning, in order to enter and work in a cleanroom environment.

Duties & Responsibilities:

  1. Support and participate in the manufacturing of drug product and intermediates, with a focus on Upstream manufacturing processes
  2. Comply with cGMP and GDP regulations
  3. Clean, operate, and store various processing equipment
  4. Collect and submit cleaning or in-process samples to Quality Control
  5. Clean and sterilize manufacturing parts
  6. Order and dispense raw materials
  7. Participate in the execution of process development or validation protocols as needed
  8. Perform inventory cycle counts and site fit-for-use inspections
  9. Perform revision and creation of SOP’s, batch records, or associated protocols under a change control program.
  10. Perform deviation initiation, investigation, resolution, and CAPA
  11. Train manufacturing personnel with similar role responsibilities.

Education & Experience

  • At a minimum, a B.A./B.S., or M.S. in a Science or Engineering field with a minimum of 3 years of relevant work experience, or a combination of education and experience.

The Manufacturing Associate III must develop the skills necessary to perform required responsibilities to achieve company objectives and goals. This person must have strong record keeping, organizational, written, and verbal communication skills to collaborative with manufacturing personnel & interdepartmentally. This candidate is desired to have previous experience utilizing good manufacturing or documentation practice.

Skills & Competencies

  • Performs tasks while maintaining cGMP compliance.
  • Experience with large-scale Upstream manufacturing processes, including: fermentation/cell culture, cell separation, cell lysis, and media preparation.
  • Ability to perform responsibilities under direct or minimal supervision.
  • Understanding of Microsoft Office Suite and/or other organizational applications.
  • Good written, verbal, and communication skills.
  • Ability to communicate interdepartmentally with Quality Control, Facilities, MSATs and Quality Assurance for manufacturing related projects.

Company

Polaris Group is a multinational biotechnology company focused on developing novel anti-cancer therapies. Our lead drug candidate, Pegargiminase (ADI‑PEG 20), is a biologic in late-stage clinical development for a wide range of cancers, including hepatocellular carcinoma, mesothelioma, pancreatic cancer, non-small cell lung cancer, melanoma, acute myeloid leukemia and others. Polaris Group is involved in every stage of the drug development process. Our family of companies harnesses structure-based drug design technology to create novel oncology therapies, conducts clinical studies at top-tier cancer centers worldwide and operates cGMP Production Facilities in Northern California and China
 

Stock Exchange: Taiwan

Stock Symbol: 6550.TDW
 

Find Us
Website
Phone
707-451-0441
Location
4941 Allison Parkway, Suite B
Vacaville
CA
95688
United States
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