Director, Pharmaceutical Analytical Sciences

Our Pharmaceutical Analytical Sciences (PAS) team is seeking a highly motivated, innovative scientific leader to advance analytical solutions that support our small molecule development pipeline. This role provides strategic and operational leadership for a team developing, qualifying, and applying analytical methods to characterize, release, and support stability for clinical drug substance and drug product.

The PAS Director 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 backed by scientifically sound, compliant analytical strategies. Success requires strategic thinking, strong people leadership, sound scientific judgment, and excellent communication, along with regulatory expertise and the ability to influence through data and collaboration.

About the Role

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. The role oversees disclosures for external publications and regulatory filings, supports resource planning, risk mitigation, and budget management, and builds a strong internal and external network across academic, industry, and regulatory communities.

Responsibilities

• 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.

Requirements

• 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.
• 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.

Skills

• 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

Pay

The salary range for this role is $173,200.00 - $272,600.00. An employee’s position within the salary range will be based on 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.

Benefits

We offer a comprehensive package of benefits, including:

• 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.

Schedule

• Travel Requirements: 10%