Job Description

Position Overview:

The Pharmaceutical Analytical Sciences (PAS) team is seeking a highly motivated, innovative scientific leader to advance analytical solutions that support our Company's small molecule development pipeline. The PAS Director provides strategic and operational leadership for a team that develops, qualifies, and applies analytical methods to characterize, release, and support stability for clinical drug substance and drug product. This role partners across process and formulation development, CMC and Regulatory, Quality, and manufacturing/commercialization stakeholders to inform control strategy and support regulatory filings, ensuring development programs are supported by scientifically sound, compliant analytical strategies.

Success in this role requires strategic thinking, strong people leadership, sound scientific judgment, and excellent communication skills, along with an understanding of the regulatory environment and the ability to influence through data and collaboration.

Required Leadership Skills:

• Sets clear direction and priorities aligned to business needs.
• Leads with a quality mindset and role-models compliance and integrity.
• Builds inclusive, high-performing teams through coaching and development.
• Collaborates across functions and influences decisions using data and scientific rationale.
• Drives continuous improvement and manages risk proactively.

Nature and Scope of Position:

The Director reports to the Executive Director of PAS and leads a Rahway-based team of approximately 10-15 scientists embedded in multidisciplinary development teams. The team is accountable for analytical method development and testing to support chemical and biochemical processes and multiple dosage forms, including parenteral, oral, and specialty products. The Director monitors regulatory expectations and industry trends to inform analytical R&D strategy and future capability needs across Development Sciences. The successful candidate brings experience operating in an innovative analytical environment, with strong alignment to regulatory expectations and GMP requirements.

The Director partners with PAS leadership to advance strategic and cultural priorities. The Director recruits, onboards, and develops talent; sets clear performance expectations; and builds sustainable development and succession plans for critical scientific and management roles. The position oversees disclosures prepared within the group to support external publications and regulatory filings, and supports resource planning, risk mitigation, and budget management as needed.

The PAS Director builds a strong internal network and maintains external connections across academic, industry, and regulatory communities, as appropriate. The Director promotes a culture of scientific excellence, collaboration, and a consistent GMP/compliance mindset across partners and stakeholders.

Essential Functions and Responsibilities (include, but are not limited to):

- Lead and advance analytical methodologies and platforms to support drug substance and drug product development.

- Apply strong project and portfolio management to deliver high-quality results on agreed timelines.

- Review, interpret, and approve data packages to ensure scientific rigor and compliance.

- Represent the laboratory during internal and external audits and drive timely, effective follow-up.

- Develop, review, and maintain SOPs and related controlled documents.

- Operate effectively within Quality Systems, ensuring inspection readiness and continuous improvement.

- Develop, coach, and retain staff; build a strong talent pipeline and inclusive team culture.

- Maintain thorough working knowledge of GMPs, ICH, and relevant FDA and global health authority guidance.

Qualifications and Skills:

Education:

• BS or MS in Chemistry or a related discipline with 12+ years of industry experience in pharmaceutical drug substance and/or drug product development.
• PhD in Chemistry or a related discipline with 8+ years of industry experience in pharmaceutical drug substance and/or drug product development.

Required:

• Demonstrated people leadership, including coaching and talent development.
• Strong scientific communication skills, creativity, and ability to influence through collaboration.
• Proven ability to work effectively in cross-functional, team-based environments.
• Demonstrated track record of delivering results on firm timelines in support of development programs and regulatory filings.

#AR&D

Required Skills:
Adaptability, Adaptability, Analytical Method Development, Biologics License Application (BLA), Chromatographic Techniques, Coach Team Members, Commercialization, Control Strategy, Decision Making, Dosage Forms, Drug Development, Global Health, Leadership, People Leadership, Pharmaceutical Development, Portfolio Management, Process Analytical Technology (PAT), Professional Networking, Quality Control Management, Quality Management, Quality Operations, Regulatory Compliance, Regulatory Submissions, Results-Oriented, Strategic Thinking {+ 2 more}

Preferred Skills:

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.

The salary range for this role is
$173,200.00 - $272,600.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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:
No

Travel Requirements:
10%

Flexible Work Arrangements:
Not Applicable

Shift:
Not Indicated

Valid Driving License:
No

Hazardous Material(s):
n/a

Job Posting End Date:
07/30/2026
*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.