Job Description
Supervise daily manufacturing activities, assign and distribute work, problem solve, coordinate emergency situations. Participate in shift change reports with the outgoing and incoming shifts and supervisors. First line of contact to handle process and equipment deviations on the floor as subject matter expert. Assist Production Operators, as needed, with prep work, autoclave, process components and filters, verify data and material movement. Coach and develop direct reports; assess goals and provide guidance to achieve success. Create a culture of safety, and continuous process improvement. Assist in the development of SOPs and skills training materials to ensure compliance with all company SOPs, policies, cGMPs and applicable safety and regulatory requirements. Partner with operational groups (QC, QA, facilities, Supply Chain, Warehouse, Packaging) to ensure timely completion of deviations, investigations, change controls, and corrective/preventive actions. Ensure Time cards of all direct reports are accurate and completed in a timely manner. Participate in Gemba walks.
ResponsibilitiesSupervise daily manufacturing activities, assign and distribute work, problem solve, coordinate emergency situations.Participate in shift change reports with the outgoing and incoming shifts and supervisors.First line of contact to handle process and equipment deviations on the floor as subject matter expert.Assist Production Operators, as needed, with prep work, autoclave, process components and filters, verify data and material movement.Coach and develop direct reports; assess goals and provide guidance to achieve success.Create a culture of safety, and continuous process improvement.Assist in the development of SOPs and skills training materials to ensure compliance with all company SOPs, policies, cGMPs and applicable safety and regulatory requirements.Partner with operational groups (QC, QA, facilities, Supply Chain, Warehouse, Packaging) to ensure timely completion of deviations, investigations, change controls, and corrective/preventive actions.Ensure Time cards of all direct reports are accurate and completed in a timely manner.Participate in Gemba walks.Essential SkillsAseptic productionGMP environmentManagement skillsSupervisory skillsProduction managementAdditional Skills & QualificationsBachelor’s degree in the life sciences, Chemical Engineering or Chemistry.Minimum 5 years of experience in pharmaceutical GMP manufacturing; Aseptic fill/finish experience preferred.Minimum 3 years experience in a supervisor role.Equivalent combination of education and directly relevant aseptic pharmaceutical leadership experience may be considered.Experience with GMPs, FDA, and other regulated agency environment.Ability to make real-time decisions on safety, process, scheduling, and HR related issues.Ability to prioritize and manage resources in a production environment.Ability to work overtime, weekends, or change shift schedule, per business needs.Work Environment
Work in a cleanroom environment with moving mechanical parts and variable noise levels. Work with biohazard materials and chemical solutions including bleach and Spor-Klenz®. Wear cleanroom garments (safety shoes & glasses, coverall, hairnet, beard cover, shoe covers, nitrile gloves, face mask). Wear cleanroom PPE. Able to remain in a stationary position for 50% of the time. Able to detect and distinguish primary colors (red, yellow, and blue) and secondary colors (green, orange, and purple) as they appear on process equipment digital displays and computer screens. Communicate verbally to exchange information, and give and receive instructions. Ability to set-up, operate, clean and maintain process equipment and handle materials. Ability to handle portable equipment weighing up to 50 lbs. and lift up to 50 lbs. Will start on the 1st shift for 4-6 months then transition to be the 2nd shift supervisor: 1st shift 7:00AM-03:15PM, 2nd shift 03:00PM-11:15PM.
About ActalentActalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & InclusionAt Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our peopleThe company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
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