Director, Pharmaceutical Analytical Sciences

MSD•Rahway, NJ

2d•$173,200 - $272,600•Onsite

About The Position

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. 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.

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.
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

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.