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The Manufacturing Supervisor will manage a team ensuring excellence in manufacturing processing as well as scheduling to meet site demands by ensuring team members receive training and development and are operating in a safe working environment. The supervisor will plan on-time execution of batch activities, deliver quality product, and will look for opportunities to continuously improve manufacturing processes.
Essential Job Functions
- Provide leadership, coaching, and mentoring to the Manufacturing organization across multiple shifts
- Hire, coach, and develop Manufacturing team members, including performance management and periodic reviews
- Oversee and execute Vector Manufacturing activities including the scheduling of resources, material staging, equipment preparation, batch execution, cleaning/sanitization, inventory transactions, and batch record review
- Complete on-time delivery of product to clients, including review of Manufacturing records and investigations
- Monitor and report on area performance, identifying opportunities for improvement and implementing process improvements
- Design, implement, maintain, and continuously improve vector manufacturing systems, policies, procedures, and programs that ensure compliance to company and regulatory body standards for Quality and EHS
- Identify and mitigate risks in Manufacturing operations that could negatively impact product and personnel safety
- Manage the Manufacturing Production system including but not limited to personnel development, problem solving, investigation of issues, root cause analysis, CAPA, 5S, visual factory, etc.
- Ensure safe working environment and compliance with OSHA, EHS, Quality, and cGMP procedures and policies within the Manufacturing department
Special Work Requirements:
- Adaptability required as work schedule may change based on business needs
- Criminal background check required
- Other duties as assigned
Education/Certifications/Licenses
- Bachelor's Degree in Life Sciences/Engineering
- In-depth knowledge of aseptic processing
On the Job Experience:
- 3 years of related work experience in a GMP environment
- 1 year of supervisory experience
- Drug Substance experience with cell culture and upstream/downstream processing
- Experience using single use system
Skills/Abilities
- Demonstrated interpersonal skills to build relationships, act as change agent, manage conflict, and adapt to rapidly changing organizational and business needs
- Ability to manage multiple priorities
- Frequently required to work in a BSL 2 environment with personal protective equipment/aseptic gowning
- Regularly required to work around large machinery and typical utilities seen in pharmaceutical facilities
- Occasionally exposed to moving mechanical parts; high, precarious places; toxic or caustic chemicals; hazardous waste; and risk of electrical shock
- Occasionally exposed to extremely loud noise levels
- Spending time on the floor during activity execution (manufacturing, maintenance, construction, commissioning, and qualification) is required
Movement:
- Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms
- Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl
Lifting:
- Frequently lift and/or move up to 10 pounds
- Rarely lift and/or move up to 25 pounds
Vision:
- Frequently utilize close vision and the ability to adjust focus
Communication:
- Frequently required to communicate by talking, hearing, using telephone and e-mail
Seniority level
Seniority level
Mid-Senior level
Employment type
Job function
Job function
Manufacturing
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Inferred from the description for this job
Medical insurance
Vision insurance
401(k)
Paid maternity leave
Paid paternity leave
Tuition assistance
Disability insurance
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