Job Description

We are seeking a strategic and technical leader with expertise in developing analytical methodologies and innovative medicines. The primary objective of the Small Molecule Analytical Research and Development (SMAR&D) team is to conduct research and development activities in collaboration with various partners to facilitate process and formulation development.

In this role, the SMAR&D Director will provide guidance, lead initiatives, and build teams responsible for developing characterization methods to evaluate and release clinical drug substances and products and their stability tests for our research pipeline.

This research opportunity supports the Development Sciences and Clinical Supplies (DSCS) goals, which focus on creating robust chemical and biochemical processes and pharmaceutical formulations for non-sterile and sterile products. The position also involves strategic collaboration with Chemistry, Manufacturing, and Controls (CMC) and Regulatory teams regarding control strategies and regulatory filings, alongside Quality and partners in the commercialization and manufacturing divisions.

This challenging position requires a clear vision for team development, demonstrated leadership skills, critical thinking abilities, effective technical and communication skills, and a strong understanding of the drug development and regulatory landscape to influence it positively.

Nature and Scope of Position:

The Director reports to the Executive Director of SMAR&D and will lead a team of approximately 10-15 scientists in Rahway, who collaborate closely within multidisciplinary teams. This role encompasses a broad range of responsibilities, including oversight of the development of analytical methods and testing for chemical and biochemical processes, as well as parenteral, oral, and specialty dosage formulations. The Director should be well-informed about regulatory and industry trends to effectively guide future activities for Analytical R&D. The candidate must have experience working in an innovative analytical, regulatory, and GMP environment.

The Director will collaborate with SMAR&D leadership and extended leadership teams to identify and advance key departmental strategic and cultural initiatives. They will also be responsible for identifying, recruiting, onboarding, and developing employees to realize their full potential. Additionally, the candidate will contribute to establishing a viable succession plan for key positions within the functional area, including both scientific and management pathways, as well as for their own role. This position is responsible for ensuring that disclosures prepared by the group serve as the basis for external publications and filings. Furthermore, the Director will oversee proactive resource planning, risk assessment strategies, and necessary budget management.

Maintaining an effective network both internally and with the external academic and regulatory community is expected. The Director will also advance a culture of scientific excellence, GMP compliance, and collaboration with various partners and stakeholders in development.

Essential Knowledge, Duties & Responsibilities include:

• Analytical Methodologies

• Project management skills

• Review and approval of data

• Representation of the laboratory for internal and external audits

• SOP development

• Quality System experience

• Team and staff development

• Thorough working knowledge of GMPs, ICH, and relevant FDA guidelines

Qualifications:

Education:

• BS or MS in chemistry or related science with 10 years of industrial experience with pharmaceutical drug substance and/or product development.

• Ph.D. in chemistry or related science with 7 years of industrial experience with pharmaceutical drug substance and/or product development.

Required:

• Demonstrated ability in leading teams with proven talent development skillsets.

• Excellent scientific communication skills, demonstrated creativity, effective interpersonal and collaborative skills

• Ability to work in a team environment with cross-functional interactions is essential

• Strength in delivering results on firm deadlines in support of drug substance and product development for clinical and commercial filings

#AR&D

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.

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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EEOC GINA Supplement​

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.

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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:

$169,700.00 - $267,200.00

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

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:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

05/1/2025

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.