Merck
Operations Associate Director
The Polysaccharide Vaccine (PV) Building 63 Operations team is seeking a highly motivated individual to fill an open Operations Associate Director position to lead the start-up of a new bulk vaccine manufacturing facility and its transition to routine manufacturing at the West Point site. The new facility is currently in the last stages of the process performance qualification process to support the successful licensure of the facility and process. Our manufacturing Operations teams are the people that make our products - we work in the manufacturing plants with a "Safety First, Quality Always" mindset striving for continuous improvement. The Associate Director, B63 Operations, is the bulk vaccine manufacturing and associated support areas business unit manager who actively supports, participates in, and embraces an empowered team culture. In this role, the Associate Director will manage an operations sub-team within the organization through process performance qualification and routine manufacturing. This role will interface with a cross-functional group that includes West Point Technical Operations, Quality, Engineering Maintenance and Utilities, Automation, Safety, and others. Unit operations include but are not limited to bulk vaccine drug substance manufacturing (fermentation and purification), and the weigh and dispense, sterile supply, and solution preparation areas that support the vaccine manufacturing. Additional responsibilities include: Accountability Lead a team of direct reports to complete successful start-up of bulk vaccine manufacturing process and associated support areas within the new manufacturing facility Support change control, risk assessments, impact assessments, and qualification activities required for regulatory submission for facility. Support regulatory inspections of facility Ensure that area objectives are achieved while reliably supplying quality product at a competitive cost consistent with our company, Regulatory Agency, and State and Local code requirements for quality, good manufacturing practices (GMP), equal employment opportunity, finances, labor, employee, environment and safety Facilitate tactical and strategic area management including collaboration with indirect staff and USW shop floor personnel Promote the behaviors and principles that drive continuous improvement Duties Compliance
responsible for creating and sustaining a culture that ensure 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 for reviewing and approving compliance documents, as per procedures or need. Supply
Lead daily area walkthrough. Exercise independent judgment and decision making to ensure quality product is reliably produced while managing cost. Responsible for area supply performance metrics (Schedule Adherence, Release on Time, Product Lead Time, customer service performance, etc.). Continuous Improvement
Accountable for developing a continuous improvement culture while achieving our Companys Production System targets and business results for the area. Develop strategic initiatives related to the manufacturing process, equipment, and human resources in support of long-range operating plans. Report area monthly metrics and any action plans to address gaps to the Integrated Process Team (IPT) leadership team. Identify, prioritize, and champion improvement projects using diverse perspectives (safety, compliance, automation, equipment, process, and people) to increase process efficiency and yield, and reduce cycle time, process variability, and deviations, and eliminate waste. Financial Stewardship
Responsible for development and management of the area operating budget as defined with the profit plan. Accountable for meeting the operating budget and continuously reducing costs. Ensure development of teams business acumen and understanding of how they impact business finances. People Management
Responsible for creating and sustaining a highly engaged workforce through utilization of our companys Leadership Behaviors and Inclusion. 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. Provide coaching on professional development and career paths. Support IPT Talent Management. In accordance with policy, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. Education Minimum Requirements: Bachelors Degree in Engineering, Science, Business Administration, or other technical field Required Experience and Skills: Minimum five (5) years of experience in more than one functional area such as Operations, Quality, Technical Operations, Engineering, Maintenance, Automation, and/or Supply Chain Concurrently, a minimum of two (2) years of line experience, with responsibility for direct reports Demonstrated leadership and teamwork skills, excellent technical and/or mechanical troubleshooting abilities, established written and verbal communication skills Preferred Experience and Skills: Minimum of two (2) years experience in relevant manufacturing or processing (bulk aseptic/sterile or low bioburden vaccine manufacturing) Demonstrated knowledge of High Performing Organization tools and methodology, including MPS/lean processing Demonstrated ability to create an engaged workforce using Inclusion as the How Demonstrated experience of interacting with site, divisional, or regulatory audits Demonstrated success with Talent Management
The Polysaccharide Vaccine (PV) Building 63 Operations team is seeking a highly motivated individual to fill an open Operations Associate Director position to lead the start-up of a new bulk vaccine manufacturing facility and its transition to routine manufacturing at the West Point site. The new facility is currently in the last stages of the process performance qualification process to support the successful licensure of the facility and process. Our manufacturing Operations teams are the people that make our products - we work in the manufacturing plants with a "Safety First, Quality Always" mindset striving for continuous improvement. The Associate Director, B63 Operations, is the bulk vaccine manufacturing and associated support areas business unit manager who actively supports, participates in, and embraces an empowered team culture. In this role, the Associate Director will manage an operations sub-team within the organization through process performance qualification and routine manufacturing. This role will interface with a cross-functional group that includes West Point Technical Operations, Quality, Engineering Maintenance and Utilities, Automation, Safety, and others. Unit operations include but are not limited to bulk vaccine drug substance manufacturing (fermentation and purification), and the weigh and dispense, sterile supply, and solution preparation areas that support the vaccine manufacturing. Additional responsibilities include: Accountability Lead a team of direct reports to complete successful start-up of bulk vaccine manufacturing process and associated support areas within the new manufacturing facility Support change control, risk assessments, impact assessments, and qualification activities required for regulatory submission for facility. Support regulatory inspections of facility Ensure that area objectives are achieved while reliably supplying quality product at a competitive cost consistent with our company, Regulatory Agency, and State and Local code requirements for quality, good manufacturing practices (GMP), equal employment opportunity, finances, labor, employee, environment and safety Facilitate tactical and strategic area management including collaboration with indirect staff and USW shop floor personnel Promote the behaviors and principles that drive continuous improvement Duties Compliance
responsible for creating and sustaining a culture that ensure 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 for reviewing and approving compliance documents, as per procedures or need. Supply
Lead daily area walkthrough. Exercise independent judgment and decision making to ensure quality product is reliably produced while managing cost. Responsible for area supply performance metrics (Schedule Adherence, Release on Time, Product Lead Time, customer service performance, etc.). Continuous Improvement
Accountable for developing a continuous improvement culture while achieving our Companys Production System targets and business results for the area. Develop strategic initiatives related to the manufacturing process, equipment, and human resources in support of long-range operating plans. Report area monthly metrics and any action plans to address gaps to the Integrated Process Team (IPT) leadership team. Identify, prioritize, and champion improvement projects using diverse perspectives (safety, compliance, automation, equipment, process, and people) to increase process efficiency and yield, and reduce cycle time, process variability, and deviations, and eliminate waste. Financial Stewardship
Responsible for development and management of the area operating budget as defined with the profit plan. Accountable for meeting the operating budget and continuously reducing costs. Ensure development of teams business acumen and understanding of how they impact business finances. People Management
Responsible for creating and sustaining a highly engaged workforce through utilization of our companys Leadership Behaviors and Inclusion. 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. Provide coaching on professional development and career paths. Support IPT Talent Management. In accordance with policy, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. Education Minimum Requirements: Bachelors Degree in Engineering, Science, Business Administration, or other technical field Required Experience and Skills: Minimum five (5) years of experience in more than one functional area such as Operations, Quality, Technical Operations, Engineering, Maintenance, Automation, and/or Supply Chain Concurrently, a minimum of two (2) years of line experience, with responsibility for direct reports Demonstrated leadership and teamwork skills, excellent technical and/or mechanical troubleshooting abilities, established written and verbal communication skills Preferred Experience and Skills: Minimum of two (2) years experience in relevant manufacturing or processing (bulk aseptic/sterile or low bioburden vaccine manufacturing) Demonstrated knowledge of High Performing Organization tools and methodology, including MPS/lean processing Demonstrated ability to create an engaged workforce using Inclusion as the How Demonstrated experience of interacting with site, divisional, or regulatory audits Demonstrated success with Talent Management