Executive Director, Vaccines Analytical Development

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 is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases. 

The Executive Director of Vaccines Analytical Development is responsible for providing strategic and technical leadership for the development, validation, implementation, and technology transfer of analytical test methods to support advancement of the pre-clinical and clinical development pipeline of new Merck vaccine products. 

The Executive Director reports directly to the Vice President, Analytical Research & Development and will be directly responsible for a multidisciplinary team of people managers and scientists, approximately 100-150 people. The team works closely with leaders and scientists within Discovery, Pre-clinical Development, Manufacturing, Quality Assurance and Regulatory groups and provides technical insights and support for our portfolio of projects from candidate nomination to marketing authorization. 

The Executive Director manages the work within his/her group and though external service providers to ensure that the goals of the project teams are met in a timely, cost-sensitive, phase-appropriate and compliant manner. He/she would be accountable for the growth/career development and performance of the Vaccines Analytical Development teams with a demonstrated ability to collaborate, build high-performing teams, develop diverse talent and set and achieve a strategic direction for the team. 

Responsibilities include, but are not limited to, the following:

1. Scientific Excellence & Innovation: Responsible for leading the overall scientific, technical and operational efforts of a department within Analytical Research & Development with delivery of analytical characterization data, methods, and process knowledge in a timely manner needed to meet project milestones and associated regulatory requirements. This includes development of novel tools and processes to position Analytical Research & Development to deliver against future pipeline needs. 

2. Quality and Regulatory Standards: Develops and implements quality standards and specifications for drug substance and drug product. Ensures the delivery of high quality CMC sections for IND/CTA/NDA filings. Addresses quality-related inquiries from regulatory agencies to support clinical trial and commercial marketing applications.

3. Compliance Systems: Sets a high compliance standard and ensures that systems and resources are in place to conduct the activities of the laboratories in compliance with cGMP/GLPs (as needed), SOPs, good documentation practices, and OSHA safety standards and in accordance with corporate requirements. Ensures overall laboratory readiness for regulatory inspections and internal audits.

4. Project Management and Teamwork: Responsible for quality, quantity and timelines for analytical projects and bringing analytical representation and expertise to CMC, project teams and task forces as appropriate. Facilitates teamwork and coordinates execution of plans with key stakeholders. Allocates resources and ensures tracking and follow-up as necessary. Ensures the department works as a partner with collaborators and teams.

5. Building Teams & Talent: Responsible for setting high standards, building and managing a high performing team. Sets department goals and performance objectives, supports talent development and proactively addresses performance issues. Identifies department needs and recruits/hires/promotes talent as appropriate to grow and progress the organization. Allocates proper resources for meeting goals and objectives. 

6. Communications: Maintains productive communications with staff, Pharmaceutical Development colleagues, Quality Assurance, Technical Operations, and CMC Regulatory Affairs as needed to ensure understanding of needs, proper prioritization and timely delivery of product knowledge, customer-oriented data and documentation. Regularly exchanges ideas and information to develop effective plans and strategies to meet business needs. 
 

Qualifications
 

Education: 

• Ph.D. in analytical chemistry, biochemistry or related pharmaceutical science

Required:
 

• 10 + years of product development experience
• Demonstrated ability in leading an analytical team. 
• Incumbent must have excellent interpersonal, communication, and collaboration skills.
• Strength in delivering results on firm deadlines in support of drug/vaccine discovery/development

Preferred:

• Experience with vaccines development is strongly preferred.

Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life. 

If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to staffingaadar@merck.com.

Search Firm Representatives Please Read Carefully: 

Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity.  Please, no phone calls or emails.  All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck.  No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.

Visa sponsorship is not available for this position.

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Job: Preclinical Dev Generic
Other Locations: 
Employee Status: Regular
Travel: Yes, 20 % of the Time
Number of Openings: 1
Shift (if applicable): 
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Company Trade Name: Merck
Nearest Major Market: Philadelphia