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Manufacturing Associate I & II

Employer
Polaris Pharmaceuticals, Inc
Location
95688, Vacaville
Start date
Jul 28, 2022

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Discipline
Manufacturing & Production, Manufacturing/Mechanical
Required Education
Associate Degree
Position Type
Full time
Hotbed
Biotech Bay
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Job Details

Role Title                         Manufacturing Associate I & II

Department                    Manufacturing  

Supervisor                       Senior Director of Manufacturing

FLSA                                Exempt

 

CORE VALUES 

 

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

 

 

FUNCTION SUMMARY      Manufacturing Associate I & II

The Manufacturing Associate I & II 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 is expected to complete quality system and production training to support drug manufacturing and perform role responsibilities. The Manufacturing Associate is expected to don coveralls and qualify for aseptic gowning, to enter and work in a cleanroom environment.

Duties & Responsibilities:

  1. Support and participate in the manufacturing of drug product and intermediates, with an emphasis on Downstream 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

Education & Experience

  • At a minimum, an Associate Degree or B.A./B.S. in a science or engineering field with a minimum of 1 year of relevant work experience (minimum of 2 years for a Manufacturing Associate II), or a combination of education and experience.

 

 

 

 

 

The Manufacturing Associate I 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. For Manufacturing Associate II, experience with either upstream or downstream biologic manufacturing. 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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