Director, Pharmaceutical Analytical Sciences

MSD•Rahway, NJ

1d•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.

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.