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vor 3 Wochen
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. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products. Development and Commercialization Teams (DCT) create and execute development, registration and supply strategies for pipeline vaccine and biologics products. DCTs are responsible for integrating late stage analytical and process development, clinical supplies manufacturing, supply chain establishment, new asset construction, technology transfer, analytical and process validation, regulatory filings, and transition to sustainable compliant commercial supply. The Director, DCT Leadership position in our Manufacturing Division is a dedicated full-time role and is accountable for leading the DCT at Line of Sight to Validation. The incumbent will lead the development of the overall strategic objectives for the Chemistry, Manufacturing and Controls (CMC) aspects of a vaccine or biologic pipeline product from LOS to validation through launch and ensures seamless execution of the development plan. As part of the project leadership group, the Director will engage in pipeline programs at the First in Human milestone. The DCT lead serves as the face of the product commercialization project to all stakeholders and relevant decision-making bodies. **Responsibilities include**: - Establishes and manages the DCT, which is composed of on-assignment representatives from various functional groups, and negotiates to obtain the right resources from the appropriate functions at the right time - Manages the team to develop project schedules, establish clear priorities and establish and monitor metrics to gauge team progress, performance, and results - Manages the team to develop technical strategies to deliver process and analytical robustness at launch - Manages the activities and deliverables across the functions to achieve the objectives of the program on time, within the program constraints as One Team - Identifies and removes obstacles to the team’s progress and resolves conflicting goals and escalates issues that cannot be resolved at the team level - Establishes networks for team communications to instill collaboration among team members and ensures that the project team members have the information required to do their jobs - Communicates effectively with governance bodies and functional area heads as needed. - Partners with functional and organizational management to facilitate rewards and recognition for individuals and teams - Primarily focused on the pipeline projects, but may also lead business improvement initiatives due to expected strength in cross-functional leadership and established network **Education Minimum Requirement**: - Bachelors Degree in Science, Engineering or Business-related discipline, PhD preferred **Required Experience and Skills**: - Leadership of cross functional teams involved in the development or manufacturing of biologics or vaccines - Work experience in biologics or vaccine development or manufacturing: > 7 years for applicant with an advanced degree (Masters or PhD), > 10 years for applicant with Bachelors degree - Demonstrated ability to lead and influence without direct line authority by establishing trust, a clear vision, and a sense of team accountability. **Preferred Experience and Skills**: - Deep understanding of all the CMC aspects of biologics and vaccines development through commercialization through participation on, and leadership of, cross functional product development teams - Clearly models ethical behavior in both speech and actions - Courage and common sense, with the ability to withstand resistance - Builds trust and credibility by delivering on promises and following through on commitments - Demonstrates a broad technical skillset that allows for pre-emptive identification of issues and their implications - Demonstrated experience in drug substance, drug product and analytical technology transfer and manufacturing - Ability to proactively identify tactical and strategic risks and to develop and embed a process for management of risks throughout the various phases of product commercialization - Ability to manage through uncertain situations and provide clear unambiguous expectations and priorities to the team to develop appropriate plans - Strong skills at team facilitation, team organization, listening, and conflict resolution - Consistently provides candid, constructive performance feedback to team, addresses unacceptable performance or behavior without hesitation- Demonstrates the ability to drive project sponsorship and gain project support and resources from key stakeholders - Ability to effectively collaborate with and influence partners across divisions and to collaborate with other team leaders - Demon
