Job Description

The Director of Biologics Potency in Analytical Research & Development is responsible for providing strategic and technical leadership for a portion of the Biologics portfolio from candidate selection through launch. The successful candidate will be responsible for resourcing planning, risk assessment strategies, talent development, and partnering to build a culture of innovation and inclusion.

The Director reports to the Executive Director, Cell Based Sciences and will be responsible for a team of approximately 10-15 senior and associate level scientists in Rahway, New Jersey. The position is accountable for developing integrated potency strategy and required analytical methods, including supporting assay transfer to GxP laboratories. They will be responsible for managing quality science and effective prioritization to bring analytical representation and expertise to project teams and support regulatory filings (e.g., INDs/IMPDs and BLAs).

The successful candidate must function well and be able to collaborate in a fast-paced, integrated, multidisciplinary team environment. Research and industry experience should demonstrate successful application and management of state-of-the-art analytical techniques to solve problems, sound scientific understanding of Critical Quality Attributes and Quality by Design principles, and advanced data analysis for drug development applications.

The Director selects, trains, and effectively works with colleagues to action development plans of personnel under her/his direction within the framework of Company policy. The 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.

Requirements:

• Ph.D. in biochemistry, analytical chemistry, molecular biology, cell biology, virology or related field with a minimum of 8 years of relevant experience; OR M.S. with a minimum of 10years of experience; OR Bachelors with a minimum of 15 years of experience in the Pharmaceutical Industry.

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

• Expertise in applying advanced concepts in cell biology and immunology to solve complex scientific and operational challenges related to designing and developing GxP assays, including enzyme-linked immunosorbent assay and cell-based assays for Biologics development.

• Expertise in a variety of technologies, such as cell line engineering to build reporter gene assays, flow cytometry, natural killer (NK) cell assays for cytotoxicity, and/or effector function assays.

• Strong knowledge and statistical skills for interpretation of potency data in context of broader process and product development, control strategy, and specifications-setting.

• Deep working knowledge of regulatory guidance and quality standards, with experience authoring and reviewing regulatory submissions and responses (biologics license application submission) and interacting with Health Authorities.

• Ability to effectively manage a portfolio of projects, multi-task in a highly dynamic environment, and influence cross-functional teams in a professional and positive manner.

• Excellent verbal and written communications skills and an ability to excel in a team-based environment.

• Strength in delivering results on firm deadlines in support of compound discovery, development and commercial filing.

Preferred Experience and Skills:

• Strong external scientific reputation including publications, regulatory guidance documents, presentations at scientific meetings, membership on (or leading) cross-company working groups or consortia.

• Proven ability to direct development of new, innovative approaches including your past work with new assay or robotic technology evaluation and shaping scientific strategy both at the platform and program level.

• Project management and/or scientific over-sight of work outsourced to Clinical Research Organizations (CROs)

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We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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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:R331027