Merck
Sterile Production Supervisor
The Formulation, Laboratory, and Experimentation (FLEx) Center is a new multi-modality (small molecule, biologics, vaccine) Drug Product development and Good Manufacturing Practice (GMP) clinical manufacturing plant in Rahway, New Jersey. The Sterile Production Supervisor manages a team of technicians for daily operations that support sterile supply, aseptic formulation, aseptic filling, and visual inspection. This role requires adherence to GMP procedures, strong attention to detail in completing GMP documentation, proficiency in electronic systems, and participation in continuous improvement projects. Positions may also support commissioning, qualification, and demonstration of new equipment and technologies. Successful candidates will collaborate closely with team members and partner groups including formulators, engineers, Quality, Safety, and Facilities management to drive overall success and performance of the area and clinical pipeline. Accountability First line operations supervisor with a team of individual contributor production direct reports Ensure that shift objectives are achieved while reliably supplying quality product at a competitive cost consistent with all applicable internal and external regulations for quality (GMP), safety, etc. Attention to Detail: Maintain meticulous records of formulation processes, including ingredient quantities, equipment used, and environmental conditions. Tactical and strategic shift management, including collaboration with indirect staff Batch Adaptability: Quickly adapt to changes in batch procedures and production schedules, demonstrating flexibility and problem-solving skills. Promote the behaviors and principles that drive continuous improvement Duties Coordinates and supervises the daily activities of individual contributors. Sets priorities for the team to ensure task completion; coordinates work activities with other supervisors and develops plans to meet short-term objectives. Identifies and resolves standard day to day quality, technical, and operational problems within own unit. Makes decisions
guided by policies and standard operating procedures
that impact the efficiency and effectiveness of own unit. Receives guidance and oversight from the Operations Director. Works within budgetary/financial objectives set by Director Compliance
Responsible for creating and sustaining a culture that ensures that compliance (Safety, Environment, cGMP, etc.) are imperatives for the business. Responsible for establishing a Right First-Time culture by reducing waste and constantly driving continuous improvement. Responsible to review and approve compliance documents, as per procedures or need. Supply
Exercise judgement and decision making to ensure quality product is reliably produced while managing cost. Responsible for Shift(s) supply performance metrics (Schedule Adherence, Release on Time, Customer service performance, Product Lead Time, etc.). Continuous Improvement
Accountable for developing a Production System (MPS) and continuous improvement culture while achieving MPS Targets and business results for the Shift(s). Develop strategic initiatives related to the manufacturing process, equipment and human resources in support of long range operating plans. Report Shift(s) monthly metrics and any action plans to address gaps to Management. Identify, prioritize and champion improvement initiatives to improve process efficiency, cycle time, and yield, reduce process variability and eliminate waste. People Management
Responsible for creating and sustaining a highly engaged workforce through utilization of Leadership Behaviors and Inclusion. Provide coaching on professional development and career paths. Provide timely feedback and performance evaluations for direct reports after obtaining the relevant input and evaluation. Provide feedback and input on performance evaluations for indirect staff. Support Talent Management. Position may require work outside of routine hours (e.g. nights / weekends), depending on business needs. Core Skillsets Aseptic experience: Experience in working in Grade A environment is required, including aseptic qualification and performing environmental monitoring. Ability to develop and lead others. Ability to be flexible and understand risk. Collaboration: Able to communicate clearly with team and work closely with other teams to ensure on time delivery of supplies. Continuous improvement Conflict resolution Leadership style
adaptive; high performance coaching; servant leader Compliance mindset to safety, environmental, and quality regulations Position Qualifications Education Minimum Requirement: Bachelor's degree in business administration, Science, Engineering or another technical field with a minimum of 4 years of experience, or at least 7 years' experience in pharmaceutical manufacturing or processing with HS diploma. Required Experience and Skills: Minimum (4) years' experience in a functional area, such as operations Management, Quality, Technical Operations, Technology, Engineering or Maintenance. Minimum (2) years' experience in aseptic/sterile drug product manufacturing or processing Preferred Experience and Skills: Minimum (2) years' direct supervisory experience. Demonstrated knowledge of Lean Demonstrated experience of interacting with site, divisional or regulatory audits Salary Range: $114,700.00 - $180,500.00 The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at
https://jobs.merck.com/us/en/compensation-and-benefits . You can apply for this role through
https://jobs.merck.com/us/en
(or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
The Formulation, Laboratory, and Experimentation (FLEx) Center is a new multi-modality (small molecule, biologics, vaccine) Drug Product development and Good Manufacturing Practice (GMP) clinical manufacturing plant in Rahway, New Jersey. The Sterile Production Supervisor manages a team of technicians for daily operations that support sterile supply, aseptic formulation, aseptic filling, and visual inspection. This role requires adherence to GMP procedures, strong attention to detail in completing GMP documentation, proficiency in electronic systems, and participation in continuous improvement projects. Positions may also support commissioning, qualification, and demonstration of new equipment and technologies. Successful candidates will collaborate closely with team members and partner groups including formulators, engineers, Quality, Safety, and Facilities management to drive overall success and performance of the area and clinical pipeline. Accountability First line operations supervisor with a team of individual contributor production direct reports Ensure that shift objectives are achieved while reliably supplying quality product at a competitive cost consistent with all applicable internal and external regulations for quality (GMP), safety, etc. Attention to Detail: Maintain meticulous records of formulation processes, including ingredient quantities, equipment used, and environmental conditions. Tactical and strategic shift management, including collaboration with indirect staff Batch Adaptability: Quickly adapt to changes in batch procedures and production schedules, demonstrating flexibility and problem-solving skills. Promote the behaviors and principles that drive continuous improvement Duties Coordinates and supervises the daily activities of individual contributors. Sets priorities for the team to ensure task completion; coordinates work activities with other supervisors and develops plans to meet short-term objectives. Identifies and resolves standard day to day quality, technical, and operational problems within own unit. Makes decisions
guided by policies and standard operating procedures
that impact the efficiency and effectiveness of own unit. Receives guidance and oversight from the Operations Director. Works within budgetary/financial objectives set by Director Compliance
Responsible for creating and sustaining a culture that ensures that compliance (Safety, Environment, cGMP, etc.) are imperatives for the business. Responsible for establishing a Right First-Time culture by reducing waste and constantly driving continuous improvement. Responsible to review and approve compliance documents, as per procedures or need. Supply
Exercise judgement and decision making to ensure quality product is reliably produced while managing cost. Responsible for Shift(s) supply performance metrics (Schedule Adherence, Release on Time, Customer service performance, Product Lead Time, etc.). Continuous Improvement
Accountable for developing a Production System (MPS) and continuous improvement culture while achieving MPS Targets and business results for the Shift(s). Develop strategic initiatives related to the manufacturing process, equipment and human resources in support of long range operating plans. Report Shift(s) monthly metrics and any action plans to address gaps to Management. Identify, prioritize and champion improvement initiatives to improve process efficiency, cycle time, and yield, reduce process variability and eliminate waste. People Management
Responsible for creating and sustaining a highly engaged workforce through utilization of Leadership Behaviors and Inclusion. Provide coaching on professional development and career paths. Provide timely feedback and performance evaluations for direct reports after obtaining the relevant input and evaluation. Provide feedback and input on performance evaluations for indirect staff. Support Talent Management. Position may require work outside of routine hours (e.g. nights / weekends), depending on business needs. Core Skillsets Aseptic experience: Experience in working in Grade A environment is required, including aseptic qualification and performing environmental monitoring. Ability to develop and lead others. Ability to be flexible and understand risk. Collaboration: Able to communicate clearly with team and work closely with other teams to ensure on time delivery of supplies. Continuous improvement Conflict resolution Leadership style
adaptive; high performance coaching; servant leader Compliance mindset to safety, environmental, and quality regulations Position Qualifications Education Minimum Requirement: Bachelor's degree in business administration, Science, Engineering or another technical field with a minimum of 4 years of experience, or at least 7 years' experience in pharmaceutical manufacturing or processing with HS diploma. Required Experience and Skills: Minimum (4) years' experience in a functional area, such as operations Management, Quality, Technical Operations, Technology, Engineering or Maintenance. Minimum (2) years' experience in aseptic/sterile drug product manufacturing or processing Preferred Experience and Skills: Minimum (2) years' direct supervisory experience. Demonstrated knowledge of Lean Demonstrated experience of interacting with site, divisional or regulatory audits Salary Range: $114,700.00 - $180,500.00 The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at
https://jobs.merck.com/us/en/compensation-and-benefits . You can apply for this role through
https://jobs.merck.com/us/en
(or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.