Director Analytical Research and Development

Job Overview

Head of Analytical Research and Development. Direct supervision of the Analytical Associate Directors, plus full-time high level analytical scientists, as applicable. Responsible for organizing the workload of Analytical group personnel by coordinating with Analytical Associate Directors and Analytical project managers/leaders. Prepare and review proposals for new and existing projects and manage projects as needed.

Responsibilities

• Works closely with the Site Head, the Senior Director of Chemical Development, the Senior Director Quality, and other site leadership to ensure successful completion of ongoing work.
• Aggressive and diligent leadership and management of programs according to established and adjusted timelines.
• Direct management responsibility for all Analytical resources.
• Direct point of contact with customers for project-related communications and coordination.
• Work closely with other R&D groups, Project Management, and other staff to coordinate project progress and resource usage.
• Project quoting, budgeting, invoicing, and reconciliation.
• Customer interactions including project discussions and updates, customer visits, contract negotiations, and dispute negotiations.
• Actively promote the results of the scientific projects within the group and to the customers.
• Maintain current knowledge of state-of-the-art of chemistry, analytical chemistry, technology, and cGMP regulations.
• Apply this knowledge to daily problems and ongoing work activities.
• Maintain current knowledge of regulations and guidances as applicable to Analytical testing and characterization of pharmaceutical products (FDA, ICH, USP, EP, JP etc.).
• Work to ensure that a spirit of teamwork, cooperation, and can-do attitude always exists within the department.
• Possess expert knowledge of laboratory PPE expectations.
• Possess expert knowledge of Analytical Chemistry and be a knowledge resource for the company and for customers.
• Project management and ensuring timelines are met.
• Works closely with other site management to provide long-range business planning and guidance.
• Thorough knowledge of and experience working under cGMP regulations.
• Excellent publication/patent record.

Qualifications/Skills

• Demonstrated leadership and project management expertise, with the ability to drive alignment and execution across complex, cross-functional initiatives.
• Deep technical expertise in Analytical Chemistry, with extensive application to active pharmaceutical ingredients (APIs) in a regulated environment.
• Exceptional communication and interpersonal skills, with the ability to influence, collaborate, and build strong relationships across diverse teams and leadership levels.
• Strong organizational and problem-solving capabilities, with a focus on delivering results in dynamic, fast-paced environments.
• Proficiency with Microsoft Office applications (Word, Excel, PowerPoint) to support data-driven decision-making and communication.
• Proven track record of exercising sound judgment and strategic decision-making in complex, ambiguous, and unprecedented situations.
• Strong commitment to talent development, including coaching, mentoring, and building high-performing teams through effective knowledge transfer.
• Demonstrated ability to analyze complex data and insights from multiple sources to develop innovative, scalable solutions.
• Proven ability to apply technical, functional, and industry expertise to design and execute initiatives that influence site and organizational strategy.
• Proven ability to anticipate challenges, plan proactively, and lead complex projects, including navigating ambiguity and driving effective resolution of critical issues.

Education, Experience & Licensing Requirements

• Ph.D. in Analytical Chemistry or a related discipline with a minimum of 10 years of relevant experience; alternatively, an M.S. with 15+ years or a B.S. with 20+ years of experience in pharmaceutical chemical process development.
• Demonstrated management experience within a pharmaceutical chemical process development or manufacturing environment.
• Proven expertise in quality control, regulatory compliance, scheduling, and organizational execution, with the ability to apply sound judgment and insight.
• Extensive experience with common analytical techniques and instrumentation (e.g., HPLC, GC, LC/GC-MS, IR).
• In-depth knowledge of compendial methods (USP, EP, JP), technical application testing, and out-of-specification (OOS) investigations.
• Strong proficiency in developing, interpreting, and implementing standard operating procedures (SOPs).
• Ability to serve as a technical expert and consultant, providing guidance across cross-functional teams.