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Job Details


Merck & Co, Inc

Executive Director, Small Molecule Analytical Research & Development

Executive

Executive Director

Yearly

No

Rahway, New Jersey, United States

Job Description

The Executive Director of Small Molecule Analytical Research & Development works cross functionally with partners in Process Research & Development and Pharmaceutical Sciences to provide strategic and technical leadership for both drug substance and product development for the small molecule pipeline. The Executive director has primary responsibilities 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 small molecule products.

The Executive Director reports directly to the Associate Vice President, Small Molecule Analytical Research & Development and will be directly responsible for a multidisciplinary team of people managers and scientists, approximately 50-75 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 their group to ensure that the goals of the project teams are met in a timely, cost-sensitive, phase-appropriate and compliant manner. They would be accountable for the growth/career development and performance of the Small Molecule Analytical Research & 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:

Scientific Excellence & Innovation: Responsible for leading the overall scientific, technical and operational efforts of a department within Small Molecule 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 Small Molecule Analytical Research & Development to deliver against future pipeline needs.

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.

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. Partners to ensure overall laboratory readiness for regulatory inspections and internal audits.

Project Management and Teamwork: Responsible for quality, quantity and timelines for development 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.

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.

Communications: Maintains productive communications with staff, colleagues across CMC development and commercialization, 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.

Education:

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

Required Experience and Skills:

  • 10 + years of product development experience

  • Demonstrated ability in leading large analytical teams and mentoring and developing talent.

  • Incumbent must have excellent interpersonal, communication, and collaboration skills.

  • Strength in delivering results on firm deadlines in support of drug/small molecule discovery/development

Preferred Experience and Skills:

  • Experience with Small Molecule development is strongly preferred.

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

Who we are …

We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for …

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

New hires in office-based roles in the US & Puerto Rico will be required, subject to applicable law, to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption to this vaccination requirement that can be accommodated without an undue burden to the operation. However, subject to applicable law, employees working in roles that the Company determines require routine collaboration with external stakeholders, such as employees in health services, customer facing commercial, or research based roles, will be required to be fully vaccinated as a condition of employment.

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

EEOC GINA Supplement​

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Pay Transparency Nondiscrimination

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Residents of Colorado:

Click here to request this role’s pay range.

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

Domestic/International

VISA Sponsorship:

Yes

Travel Requirements:

25%

Flexible Work Arrangements:

Not Specified

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

Requisition ID:R189958