Manufacturing Associate I

Role Title: Manufacturing Associate IDepartment: ManufacturingSupervisor: MFG ManagerFLSA: ExemptCORE VALUES Respect ● Passion ● Teamwork ● Integrity ● Honesty ● Commitment ● CollaborationROLE SUMMARYThe 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 AFSDaily Manufacturing support, cleaning, autoclave and parts washWork closely with Manufacturing leadership team, MSAT, Quality, and Scheduling to meet short and medium term objectivesResponsible for escalations as neededDrive a culture of continuous improvementDevelop area technicians in both expertise and production knowledgeComply with cGMP and GDP regulationsOrder and dispense raw materialsPerform inventory cycle counts and site fit-for-use inspectionsPerform revision and creation of SOP's, batch records, or associated protocols under a change control programPerform deviation initiation, investigation, resolution, and CAPAMaintain 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 toursEnsure systems and processes are properly maintained to ensure staff's safety, product quality, and continuity of supplyEnsure that staff are appropriately trained and qualified for the activities they perform prior to executionEnsure on-site presence for their staff and themselvesWork overtime (including outside of normal business hours) as needed per business requirementsJOB REQUIREMENTSBachelor'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 experienceKnowledge of large molecule biopharmaceutical manufacturing processes and equipmentAbility to work on-site full-time as requiredAbility to lift and carry up to 40 poundsWork overtime as required, including outside of normal business hoursAbility to stand for a prolonged period operating manufacturing equipment, including in an ISO5 cleanroom

Created: 2025-02-25