Executive Director, Biologics Analytical Research & Development

Job Description

Our Research Scientists are our Inventors. We identify and target steps in disease mechanisms or pathways that could be inhibited or enhanced. Our goal is to isolate a compound that is effective against a disease target. Using innovative thinking stateoftheart facilities and robust scientific methodology we collaborate to discover the next medical breakthrough.

Our team in Rahway New Jersey is seeking an exceptional leader who is passionate about leading a team of Scientists to deliver analytical solutions that enable and accelerate process and product development and manufacturing and ensure safety and quality of our products. The successful candidate will be accountable for proactive resourcing planning risk assessment strategies and will focus on talent development and partnering to build an integrated culture of innovation across modalities and will partner with crossfunctional development teams to enable pipeline decisions.

The Executive Director Biologics Analytical Research and Development (BAR&D) is responsible for providing strategic and technical leadership for analytical development of candidates from the discovery interface through first product registration. They will be responsible for a portfolio of Biologics programs (approximately 1015 programs) and leading multiple Director lead Development teams overall approximately 4050 scientists. Strategic partnering with Biologics Analytical Research and Development method development GMP laboratories complementary areas of Analytical Research and Development Biologics Process Research and Development CMC and Regulatory in aspects of control strategy and filings Quality and our partners in the commercialization and manufacturing is essential.

The successful candidate must function well and be able to collaborate in a fastpaced integrated multidisciplinary team environment. Research and industry experience should demonstrate successful application and management of stateoftheart analytical techniques to solve problems including strong background and experience in separations science extensive experience with UPLC/HPLC analysis of biologics (e.g. SEC RP IEX) experience in microbiological techniques ELISA PCR cell based analytics background in analytical methodologies and sound scientific understanding of Critical Quality Attributes/QbD/DOE principles as well as data analysis and statistics for setting specifications. The incumbent will be responsible for the recruiting appraisal and development of personnel under their supervision.

The Executive Director selects trains and effectively works with colleagues to action development plans of personnel under their direction within the framework of Company policy. The Executive Director will be a manager of managers with keen focus on coaching and mentoring organizational leaders in talent role will also be responsible for proactive resourcing planning risk assessment strategies and budget management as necessary (including merit and promotion planning). Maintaining a strong network internally and across the external academic and regulatory community is expected as well as advancing a culture of scientific excellence compliance mindset and collaboration with various partners and stakeholders in development.

Education:

• BS Degree with 17 years of relevant experience or MS with 10 years of relevant experience or Ph.D. in analytical chemistry or related field with 8 years of relevant experience in the pharmaceutical industry

Required Experience and Skills:

• Excellent verbal and written communication skills demonstrated creativity strong interpersonal and collaborative skills

• Demonstrated ability in leading crossfunctional groups with proven talent development skillsets.

• Ability to work in a team environment with crossfunctional interactions is essential

• Strength in delivering results on firm deadlines in support of compound from development through Commercialization

• A strong aptitude for and previous experience in managing inclusive scientific teams and attracting developing and retaining diverse talent.

• Extensive knowledge of and handson work in applying regulatory guidance and quality standards related to product release and safety.

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U.S. Hybrid Work Model

Effective September 5 2023 employees in officebased positions in the U.S. will be working a Hybrid work consisting of three total days onsite per week Monday Thursday although the specific days may vary by site or organization with Friday designated as a remoteworking day unless business critical tasks require an onsite Hybrid work model does not apply to and daily inperson attendance is required for fieldbased positions; facilitybased manufacturingbased or researchbased positions where the work to be performed is located at a Company site; positions covered by a collectivebargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note this Hybrid work model guidance also does not apply to roles that have been designated as remote.

The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors which may include but not be limited to the primary work location and the chosen candidates relevant skills experience and education.

Expected US salary range:

Available benefits include bonus eligibility long term incentive if applicable health care and other insurance benefits (for employee and family) retirement benefits paid holidays vacation and sick days. A summary of benefits is listed here.

San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:We will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of applicable state and local laws including the City of Los Angeles Fair Chance Initiative for Hiring Ordinance

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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 preexisting agreement is in place. Where agency agreements are in place introductions are position specific. Please no phone calls or emails.

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