Director, Varicella DS Technical Operations

Job description

Job Description Our Engineers support internal and external manufacturing operations remain operational, continuously improve and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation. GENERAL SUMMARY: The Director, DS Technical Operations for the Varicella Bulk B12 and B62 IPTs within the LVV E2E Technical Operations at the West Point site is responsible for the oversight of one or more technical teams. The primary responsibility of the Director is providing leadership and expertise in monitoring and improving production process performance, continuous improvement projects, process validation, sterilization and cleaning validation, change implementation, deviation investigations and CAPA implementation among other related duties. We seek someone that values diversity and inclusion for the Director of technical operations role. GENERAL PROFILE: Builds talent by coaching and developing the members of the Technical Operations team to ensure appropriate breadth, depth and skill sets across the team to maintain and drive the business forward. Provides/solicits regular feedback from team and colleagues. Develops technical/professional staff through coaching, assignment selection and associated training. Responsible for building/growing the organization’s functional excellence. Recruit and direct engineers and scientists as necessary. Develops technical/professional staff through mentoring, assignment selection and training. Manages team resources and prioritizes as aligned with business needs to include run the business support, project support, and continuous improvement activities – e.g. improve safety/compliance, reduce cost and increase consistency and efficiency. Provides leadership on schedule, priorities, and issue resolution to aid the team in accomplishing business objectives. Adapts and implements departmental plans and priorities based on-site and End-to-End scorecard to address local business, service and operational challenges. Collaborates and engages with multiple functional organizations such as Operations, Technology, Quality, Automation, Global Engineering Services, Procurement, Finance, Above Site Technology, Regulatory, among others, to develop and maintain processes that meet cGMP and business requirements. Provides technical guidance to staff, colleagues or customers as well as anticipates and interprets the customer needs to identify solutions. Includes approval of technical documentation including investigations, protocols, qualification, validation etc. as required. Responsible for presenting technical discussions to regulatory agencies during inspections. Adapts technical support model to address resource and operational challenges and evolving business needs. Responsible for the performance and results of the overall technical team. BUSINESS EXPERTISE: Applies management skills to align staff activities with department objectives. FUNCTIONAL EXPERTISE: Work with a cross-functional team within the IPT consisting of Operations, Technology, Quality, Automation, and Regulatory team members, among others, to develop and maintain manufacturing processes that meet cGMP and business requirements. Utilize core technology principles to design, develop or maintain processes to clean, sterilize, and manufacture vaccine products.· Develop technical and manufacturing documents necessary for process design/definition, engineering studies, process demonstration, process change and/or validation.· Assist with troubleshooting and effectively resolving problems. Develop and implement corrective actions to unplanned (atypical) manufacturing events to ensure a consistent and reliable supply and prevent a recurrence. Ability to examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) to best understand and resolve the root cause. Provide leadership on schedule, priorities, and issue resolution to aid the team in accomplishing business objectives. Coordinate the work of the IPT technical team to identify and implement technology-driven productivity and cost improvements. Exhibit behaviors focused on equipment uptime, minimizing cost and maintaining process consistency. Assist in authoring regulatory submissions and presenting work to multiple regulatory agencies throughout the inspection process. Responsible for building/growing the team’s functional excellence. Recruit and direct engineers and scientists as necessary. Develops technical/professional staff through mentoring, assignment selection and training. Forecasts resource needs for technical team. Monitors the health of the process through continuous monitoring and the annual process review or continuing validation activities. Develops and assures consistent application of standardized work, engineering and process tools. Links with key functional leads on site and above site to provide input on behalf of the site team. PROBLEM SOLVING: Directs the resolution of complex technical or business problems. Identifies and resolves technical and operational problems using lean/six sigma tools. Effectively collaborates with peers on site and above site as required. Expert application of problem solving skills. IMPACT: Influence Explains difficult concepts and persuades others to adopt point of view. Communicates information, asks questions and checks for understanding. Accountability Accountable for the performance of work group. Decision Making Makes decisions – guided by policies, procedures and department objectives. Consults on an as-needed basis with next-level manager on more complex decisions. STRATEGIC PLANNING: Adapts and implements departmental plans and priorities based on department and site scorecard to address local business, service and operational challenges. RESOURCE MANAGEMENT: Forecasts resource needs; manages allocated budget. Education Minimum Requirement: B.S. degree in Engineering or Sciences. Required Experience and Skills: Minimum 10 years post-bachelor’s degree experience in GMP manufacturing and/or technical support of GMP manufacturing operations (or M.S./ PhD degree plus 6 years). Tech Ops experience in biologics, vaccine or bulk sterile manufacturing facilities. Minimum of 3 years of Management or Supervisory experience. Highly developed communication, leadership and teamwork skills. Experience leading and managing departmental or cross-functional teams. Regulatory inspection presentation experience with external regulatory authority representatives. Preferred Experience and Skills: Advanced degree (M.S., PhD) in Engineering or Sciences and/or relevant work experience. Sterile manufacturing experience. Validation experience. Regulatory inspection presentation experience with external regulatory authority representatives. Working Relationships: Reports to End-to-End Technical Operations Lead. Manages and interacts with employees within own organization. Frequent interaction with employees from other IPTs, sites and external suppliers. Interacts with representatives from regulatory agencies. Required Skills: Biopharmaceutical Industry, Change Adoption, Change Agility, Consulting, Continuous Monitoring, Corrective Action Management, GMP Compliance, Good Manufacturing Practices (GMP), Key Client Relationships, Manufacturing Scale-Up, People Leadership, Pharmaceutical Process Development, Process Characterization, Process Manufacturing, Regulatory Compliance, Regulatory Experience, Resource Management, Results-Oriented, Strategic Management, Strategic Planning, Teamwork, Technical Transfer, Writing Technical Documents Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our com