Operations Manager - Vaccine Manufacturing
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.
As part of Merck's Vaccine Bulk Facility, the Durham VBF team is seeking a highly motivated individual to serve as an Operations Manager. The operations manager will be an integral member of the Varicella Bulk Facility (VBF) Operations team with responsibility for direct support of operations on the production floor, support of batch release including operations batch record review, and problem solving to drive short to long-term continuous improvement initiatives. This person may be asked to assist and/or lead projects outside of their functional area as business needs arise.
As Operations Manager, this person will be responsible for:
- All personnel in reporting structure. This includes, but not limited to, hiring, performance management, 1:1’s, Employee Developing Plans, vacation and time approving within VBF
- Provides support for all production activities, resolving critical issues on a daily basis to ensure consistent supply.
- Facilitates real-time formal problem solving techniques, such as root cause analysis utilizing Lean Six Sigma tools to solve complex production and equipment problems.
- Responsible for all process in the area. This includes, but not limited to, planning, schedule adherence, performance to plan, quality notifications, procedure changes, safety investigations /improvements and shift change.
- Assists other shift managers in providing leadership to the production floor. Capable of providing primary leadership to team during extended periods of manager absence such as vacations.
- Works in an inclusive manner, treating all team members with respect and helping to create a positive and continuously improving work environment within the team.
- Possesses thorough compliance experience (cGMP and EH&S) and is capable of participating positively in both internal and external regulatory inspections.
- Executes and manages operations batch record review within established timelines for release and effectively liaisons with quality to resolve comments in a timely manner.
- Provides technical expertise and oversight on the production floor, understanding the full process requirements compliance, equipment, regulatory) in order to best understand and resolve production issues.
- Facilitates continuous improvement projects that results in quantifiable improvements in lead time reduction, lower cost and improved quality
- Drives continuous improvements and corrective actions within the VBF team. Works with production floor personnel to develop and implement the counter-measures necessary to improve production and equipment reliability as well as the compliance posture of the team.
- Understands lean principles and applies these concepts to all aspects of the production environment. Recognizes and investigates opportunities for improving the business through financial savings etc.
- Serves as liaison between the VBF team and support groups in resolving day to day issues and in support of various projects and initiatives including the tech transfer of new products.
- Works independently and is capable of balancing shifting priorities without introducing disruption to the organization.
- Capable of working through uncertainty with minimal levels of manager direction.
In addition to these responsibilities and more specific skills, this position will require the ability to work in a team environment collaborating effectively with other team members as well as external stakeholders. Good verbal and written communication skills will be very important in this role.
Education Minimum Requirement:
Minimum of a High School Diploma/GED or higher and relevant work experience
Preferred: Bachelor’s degree or higher and relevant work experience
Required Experience and Skills:
- Willingness to work a 12 hour 2-2-3 shift schedule on Days.
- Minimum 4 years of relevant experience in a manufacturing, technical, or mechanical support role in a high-volume lean operation.
- Thorough working knowledge of cGMP and of regulatory requirements as they apply to the vaccine and/or pharmaceutical industry
- Previous leadership experience either by leading teams or projects
- Participated in cross functional teams in and out of functional area that resulted in quantifiable improvements in lead time reduction, lower cost and improved quality
- Technical writing and document review experience (i.e. deviations, change requests, standard operating procedures, batch records, protocols, etc.).
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.
If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to firstname.lastname@example.org.
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Visa sponsorship is not available for this position.
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Job: Manuf./Operations Generic
Employee Status: Regular
Number of Openings: 1
Shift (if applicable):
Hazardous Materials: Cleaning and Disinfecting Chemicals
Company Trade Name: Merck