Job Description

The Executive Director for Cell Based Sciences within Analytical R&D is responsible for providing strategic leadership and partnering with the scientists in the organization in the definition of potency strategy and development, validation, implementation, and technology transfer of potency assays (cell based and immunoassay) to support advancement of our company's pipeline of Biologics and Vaccines products from pre-clinical through clinical development and into commercial supply.

The Executive Director reports to the Vice President, Analytical Research & Development and will be directly responsible for a multidisciplinary team of people managers and scientists (100 people across Rahway, NJ and West Point, PA). The team works closely with leaders and scientists within the Discovery, Pre-clinical Development, Manufacturing, Quality Assurance and Regulatory organizations and provides the appropriate assays and characterization data for our portfolio of products from pre-candidate nomination through marketing authorization.

The Executive Director manages the work within their group and though external service providers to ensure that the goals of the project teams are met in a timely, cost-effective, phase-appropriate and compliant manner. They would be accountable for the growth/career development and performance of the Cell Based Sciences 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 setting the vision for the overall scientific, technical and operational efforts of a key department within Analytical Research & Development and partnering with the scientific leaders on the delivery of potency 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.

• Quality and Regulatory Standards: Partners with the Development teams to develop and implement quality standards and specifications for drug substance and drug product. Ensures the delivery of high quality CMC sections for IND/BLA 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. Ensures overall laboratory readiness for internal audits and regulatory inspections as required.

• Collaboration and Teamwork: 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 across the network of sites and functions.

• 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, 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.

Education:

• Ph.D. in analytical chemistry, biochemistry, biology, chemical or biological engineering or related pharmaceutical science with 10 + years of product development experience or MS with 15+ years of product development experience

Required Experience and Skills:

• 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 discovery/development

Preferred Experience and Skills:

• Experience with biologics and/or vaccines development is strongly preferred.

• Visionary with an established track record in leading research and scientific problem solving.

• Demonstrated commitment towards scientific advances for potency assays development and link to mechanism of action for large molecules, progressing new technologies and methodologies.

• In this role, there would be specific focus on the integration of strategies across the large molecule space, and evaluation of progressive methodologies, driving implementation to the development and commercialization space.

• Engage in the scientific community to share advances and progress the field, including working with recognized academic leaders in the field, publish findings and conclusions in peer reviewed scientific publications, and present same at appropriate scientific conferences and forums.

The position can be based out of our Rahway, NJ or West Point, PA campus, with the expectation of regular travel between both locations to effectively collaborate with teams at each site.

Current Employees apply HERE

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U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining 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 candidate's 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 pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

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Requisition ID:R339451