MSD
Overview
The Associate Director, Technical Operations, is responsible for the management and oversight of the technical support teams for the MMR Bulk team within the Live Viral Vaccine End-to-End at the West Point site. The role leads the technical team in supporting run-the-business activities, including production process performance, operations support, process validation, cleaning and sterilization validation, equipment/automation troubleshooting, implementation of process/equipment/analytical changes, and oversight of the deviation management team with robust CAPA installation. Limited off-shift or weekend coverage may be required based on business unit needs and assignments. Responsibilities
Builds talent by coaching and developing Technical Operations team members to ensure breadth, depth, and skill alignment with business needs; provides/solicits regular feedback and develops staff through coaching and training. Recruit and direct engineers and scientists; manage resources and priorities across run-the-business support, project work, and continuous improvement activities to improve safety/compliance, reduce cost, and increase consistency and efficiency. Provide leadership on project schedules and issue resolution; adapt plans based on site and End-to-End scorecards to address local business and operational challenges. Collaborate with multiple functional groups (Operations, Technology, Quality, Automation, Global Engineering Services, Procurement, Finance, Above Site Technology, Regulatory) to develop processes that meet cGMP and business requirements. Provide technical guidance to staff and anticipate customer needs to identify solutions; approve technical documentation including investigations, protocols, qualification, validation, and related records. Present technical discussions to regulatory agencies during inspections as required; serve as primary technical reviewer/approver for investigations and significant process changes. Lead regulatory inspection activities for the facility and apply lean/six sigma problem-solving tools to identify and resolve technical and operational issues. Qualifications
Education : Minimum Requirement: B.S. degree in Engineering or Sciences. Required Experience and Skills : Minimum 8 years post-bachelor’s degree experience in GMP manufacturing and/or technical support of GMP manufacturing operations (or PhD + 6 years); minimum two years of management/supervisory experience; experience in biologics, vaccine, or bulk sterile manufacturing facilities in a process or validation support role; strong communication, leadership, and teamwork skills; experience leading and managing departmental or cross-functional teams. Preferred Experience and Skills : Advanced degree (M.S., PhD) in science or engineering; sterile manufacturing experience; validation experience; Six Sigma certification; regulatory inspection presentation experience with external regulators. Working Relationships
Reports to Technical Operations Director. Manages employees within own department. Interfaces with internal and external stakeholders, including regulatory agencies and suppliers. Additional Info
Hybrid work model in the U.S. (three days on-site per week, Friday remote) applies to eligible positions; some roles that are field-based or not remote may be excluded. Salary range: $139,600.00 – $219,700.00; eligibility for annual bonus and long-term incentives; comprehensive benefits package. The posting includes location-specific notes and equal employment opportunity statements as required by law. Employment notices: Current employees and contingent workers may apply. Travel up to 10%. Relocation: Domestic. VISA Sponsorship: No. This position is subject to applicable residency and local hire laws. Equal Opportunity Statement : The company is committed to inclusion and prohibits discrimination on the basis of race, color, religion, sex, national origin, protected veteran status, disability status, or other legally protected characteristics. As a federal contractor, affirmative action requirements apply for protected veterans and individuals with disabilities. For more information about personal rights under U.S. EEO laws, visit the official government sites.
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The Associate Director, Technical Operations, is responsible for the management and oversight of the technical support teams for the MMR Bulk team within the Live Viral Vaccine End-to-End at the West Point site. The role leads the technical team in supporting run-the-business activities, including production process performance, operations support, process validation, cleaning and sterilization validation, equipment/automation troubleshooting, implementation of process/equipment/analytical changes, and oversight of the deviation management team with robust CAPA installation. Limited off-shift or weekend coverage may be required based on business unit needs and assignments. Responsibilities
Builds talent by coaching and developing Technical Operations team members to ensure breadth, depth, and skill alignment with business needs; provides/solicits regular feedback and develops staff through coaching and training. Recruit and direct engineers and scientists; manage resources and priorities across run-the-business support, project work, and continuous improvement activities to improve safety/compliance, reduce cost, and increase consistency and efficiency. Provide leadership on project schedules and issue resolution; adapt plans based on site and End-to-End scorecards to address local business and operational challenges. Collaborate with multiple functional groups (Operations, Technology, Quality, Automation, Global Engineering Services, Procurement, Finance, Above Site Technology, Regulatory) to develop processes that meet cGMP and business requirements. Provide technical guidance to staff and anticipate customer needs to identify solutions; approve technical documentation including investigations, protocols, qualification, validation, and related records. Present technical discussions to regulatory agencies during inspections as required; serve as primary technical reviewer/approver for investigations and significant process changes. Lead regulatory inspection activities for the facility and apply lean/six sigma problem-solving tools to identify and resolve technical and operational issues. Qualifications
Education : Minimum Requirement: B.S. degree in Engineering or Sciences. Required Experience and Skills : Minimum 8 years post-bachelor’s degree experience in GMP manufacturing and/or technical support of GMP manufacturing operations (or PhD + 6 years); minimum two years of management/supervisory experience; experience in biologics, vaccine, or bulk sterile manufacturing facilities in a process or validation support role; strong communication, leadership, and teamwork skills; experience leading and managing departmental or cross-functional teams. Preferred Experience and Skills : Advanced degree (M.S., PhD) in science or engineering; sterile manufacturing experience; validation experience; Six Sigma certification; regulatory inspection presentation experience with external regulators. Working Relationships
Reports to Technical Operations Director. Manages employees within own department. Interfaces with internal and external stakeholders, including regulatory agencies and suppliers. Additional Info
Hybrid work model in the U.S. (three days on-site per week, Friday remote) applies to eligible positions; some roles that are field-based or not remote may be excluded. Salary range: $139,600.00 – $219,700.00; eligibility for annual bonus and long-term incentives; comprehensive benefits package. The posting includes location-specific notes and equal employment opportunity statements as required by law. Employment notices: Current employees and contingent workers may apply. Travel up to 10%. Relocation: Domestic. VISA Sponsorship: No. This position is subject to applicable residency and local hire laws. Equal Opportunity Statement : The company is committed to inclusion and prohibits discrimination on the basis of race, color, religion, sex, national origin, protected veteran status, disability status, or other legally protected characteristics. As a federal contractor, affirmative action requirements apply for protected veterans and individuals with disabilities. For more information about personal rights under U.S. EEO laws, visit the official government sites.
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