Role Title: Manufacturing Associate I
Department: Manufacturing
Supervisor: MFG Manager
FLSA: Exempt
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
