What are the responsibilities and job description for the Manufacturing Associate I position at Polaris Pharmaceuticals Inc.?
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
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