Associate Director, Global Technical Operations External Biologics
Location: West Point, Pennsylvania
Posted: January 25, 2017
Reference ID: CHE005158
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. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us.
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.
The Global Technical Operations External Biologics Associate Director will be the key technical leader interfacing between Merck and External Partners (EP) in the Bulk Biologics Drug substance manufacturing area. This individual will create, lead and execute technical transfers to and from External Partners. Representative will provide manufacturing process support to External Partners to resolve production issues and to provide guidance on process and capacity optimization. This individual will be capable of leading several high impact, complex, cross-functional divisional teams and will provide significant leadership to the department. The incumbent must have bulk biologics drug substance manufacturing experience with broad biological process sciences and analytics, strong leadership skills, business acumen and interpersonal skills.
Activities will include:
Reports to Director, GTO External Biologics, and receives general direction on goals and objectives. Functions independently and provides coordination, communication, and oversight of assigned External Partner technical issues.
Executes technical transfers, site readiness activities and identification of site readiness risks and develops mitigation plans.
Provides on-going support to External Partners to resolve manufacturing issues, and develops plans to meet capacity needs.
Collaborates with Procurement, External Manufacturing Operations, External Quality, Regulatory and others to evaluate External Partners for inclusion in the Merck Network.
Executes technical due diligence assessments at External Partners.
In concert with Commercialization, Quality, and Regulatory, ensures that EP's are inspection ready for all new product introductions and transfers.
Develops and executes validation strategies for new and existing products.
Provides a single point of technical contact to assigned External Partners, impacted MMD sites and Commercialization.
Provides expert consultation and technical review of bulk biologics manufacturing processes.
Provides a 'calibrated' technical review of External Partner process change requests, deviations, and Master Batch Record changes.
Understands the true regulatory requirements and partners with Operations, Quality, and the External Partner to develop more efficient ways to meet these requirements.
Based on calibrated oversight model, minimizes duplication of efforts between External Partner and Merck systems.
Collaborates with External Partners to achieve business goals and to establish a common culture that benefits both Merck and EP.
Steers internal/external debate and discussions at high levels and guides constituents towards consensus around strategic/policy making topics.
Guides and coaches others in change leadership.
Education Minimum Requirement:
Qualified candidates must have a minimum BS in chemical/biochemical engineering, pharmaceutical science or chemistry/biology
Required Experience and Skills:
Qualified candidates must have a minimum of 10 years manufacturing experience in the areas of bulk biologics manufacturing and technical transfer or have demonstrated experience in these areas.
Preferred Experience and Skills:
External Manufacturing experience.
Our employees are the key to our company's success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company's benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at firstname.lastname@example.org.
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Visa sponsorship is not available for this position.
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