Director, Integrated Development & Supply Teams Project Leadership
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
Integrated Development and Supply Teams (IDST) create and execute development, registration and supply strategies for pipeline vaccine and biologics products. IDSTs 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, IDST Leadership position is a dedicated full time role and is accountable for leading the integrated development and supply team. The incumbent would lead the development of the overall strategic objectives for the CMC aspects of the product from late stage clinical development through launch and ensures seamless execution of the development plans. The IDST lead serves as the face of the product commercialization project to all stakeholders and relevant decision-making bodies.
Responsibilities include but are not limited to:
- Establishing and managing the IDST, which is composed of on-assignment representatives from various functional groups, and negotiates to obtain the right resources in the right jobs at the right time.
- Leading the team to develop project schedules, establishing clear priorities and establishing and monitoring metrics to gauge team progress, performance, and results.
- Managing the activities and deliverables across the functions to achieve the objectives of the program on time, within the program constraints.
- Identifying and removing obstacles to the team’s progress and resolving conflicting goals and escalating issues that cannot be resolved at the team level.
- Establishing networks for team communications to instill collaboration among team members and ensuring that the project team members have the information required to do their jobs.
- Communicating effectively with governance bodies and functional area heads as needed.
- Partnering with functional and organizational management to facilitate rewards and recognition for individuals and teams.
- Bachelors degree in Science, Engineering or Business-related discipline, PhD preferred
- Leadership of cross functional teams involved in the development or manufacturing of biologics or vaccines
- Work experience in biologics or vaccine development or manufacturing: Minimum of seven (7) years for applicant with an advanced degree (Masters or PhD), Minimum of ten (10) years for applicant with Bachelors degree
- 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 intuitively apply knowledge to identify opportunities for improvement in project management and implementation
- 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
- Demonstrates the ability to deliver sensitive and difficult messages with tact, diplomacy, and understanding of the target audience
If you need an accommodation for the application process please email us at firstname.lastname@example.org.
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Job: Product Dev Proj/Prog Mgmnt
Other Locations: Kenilworth, NJ, US
Employee Status: Regular
Travel: Yes, 25 % of the Time
Number of Openings: 1
Shift (if applicable): 1st
Company Trade Name: Merck