Manufacturing Associate I/II Job at Polaris Pharmaceuticals Inc., Vacaville, CA

QTB0NG92QWJ4MVFRMHc0ZnpJZHh2a2s1
  • Polaris Pharmaceuticals Inc.
  • Vacaville, CA

Job Description

Role Title : Manufacturing Associate I/II (Downstream)

Location : Vacaville

Department : Manufacturing

Supervisor : MFG Manager

FLSA : Exempt

Salary Range : $68,640-$70,000

CORE VALUES

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

ROLE SUMMARY

The MFG Associate I is responsible for the manufacturing of Polaris’ drug substance and/or drug product portfolio. This includes support and collaboration with manufacturing customers and partners, including Quality, MSAT, Facilities, and management, that results in safe, high quality, and continuously improving production, while maintaining full compliance with current Good Manufacturing Practices, and Polaris’ corporate principles, quality policies, and standards. This position supports fermentation, purification (CLF), and aseptic fill suite (AFS) areas of manufacturing.

ROLE RESPONSIBILITIES

  • Daily GMP Manufacturing operation activities in the cleanroom and AFS
  • Daily Manufacturing support, cleaning, autoclave and parts wash
  • Work closely with Manufacturing leadership team, MSAT, Quality, and Scheduling to meet short and medium term objectives
  • Responsible for escalations as needed
  • Drive a culture of continuous improvement
  • Develop area technicians in both expertise and production knowledge
  • Comply with cGMP and GDP regulations
  • Order and dispense raw materials
  • Perform inventory cycle counts and site fit-for-use inspections
  • Perform revision and creation of SOP’s, batch records, or associated protocols under a change control program
  • Perform deviation initiation, investigation, resolution, and CAPA
  • Maintain Polaris’ right-to-operate: Ensure cGMP production of products in compliance with all applicable Health Authority requirements and Polaris’ Quality Management System Maintain inspection readiness, and serve as an area SME during inspection tours
  • Ensure systems and processes are properly maintained to ensure staff’s safety, product quality, and continuity of supply
  • Ensure that staff are appropriately trained and qualified for the activities they perform prior to execution
  • Ensure on-site presence for their staff and themselves
  • Work overtime (including outside of normal business hours) as needed per business requirements

JOB REQUIREMENTS

  • Bachelor’s degree, preferably in Life Sciences or engineering with 2-3 years of relevant work experience, or associates degree and 4+ years of relevant work experience, or high school diploma and 5+ years of relevant work experience
  • Knowledge of large molecule biopharmaceutical manufacturing processes and equipment
  • Ability to work on-site full-time as required
  • Ability to lift and carry up to 40 pounds
  • Work overtime as required, including outside of normal business hours
  • Ability to stand for a prolonged period operating manufacturing equipment, including in an ISO5 cleanroom

Job Tags

Full time, Temporary work, Work experience placement,

Similar Jobs

American Red Cross of Central PA

VOLUNTEER JOB Blood Donor Drive Receptionist Perry County Job at American Red Cross of Central PA

 ...assist with post-donation care, and express gratitude to ensure every donor feels valued. Duties involve in-person activities at Red Cross facilities. Qualifications Must be age 13-15 with additional adult supervision* or 16+ (must be mature enough to maintain confidentiality... 

GIA Legacy Planning

Licensed Life and Health Insurance Agent - Remote... Job at GIA Legacy Planning

 ...Company: GIA Legacy Planning Location: Remote Position/Work from Home Job Type: Full-Time | Part-Time | Uncapped Commission...  ...Overview: We are seeking motivated Licensed Life and Health Insurance Agents who are eager to grow their careers while enjoying the... 

Kura Sushi Bellevue

Sushi Prep/Line Cook Job at Kura Sushi Bellevue

 ...Bellevue Come join theKura Krew,a team that is passionate about food, culture and providing a unique experience! Wages: $17.38/hour...  ...to apply** Check out our Benefits!- -benefits Line Cooks/Prep Cooks at Kura are: Team players that go above and beyond... 

Koinonia Family Services

Housing Navigator Job at Koinonia Family Services

 ...in the lives of vulnerable individuals in your community? If yes, consider joining the team at Koinonia Family Services as a Housing Navigator in our Community Supports program in Temecula, also serving parts of San Bernardino and San Diego. This part-time position helps... 

Indiana Oral & Maxillofacial Surgery Associates

Oral Surgery Assistant Job at Indiana Oral & Maxillofacial Surgery Associates

 ...an AMAZING team! Our ideal applicant will have experience assisting with clinical procedures and carrying out all other functions...  ...and post-op procedures. Dental assistants with an interest in oral surgery as well as new dental assisting graduates are encouraged to apply...