Director Analytical Research and Development

Germer International - Pharmaceutical Recruiting; Durham (NC); On-site; USD 190,000 - 230,000; Full time

Job summary

Germer International – Pharmaceutical Recruiting is seeking a Director of Analytical Research and Development for a global pharmaceutical company. This leadership role directs the Analytical group, guiding senior scientists and project managers to advance programs from clinical to commercial readiness.

You will set priorities, manage budgets, ensure cGMP compliance, and coordinate with site leaders. The position requires strong publication/patent credentials and deep analytical chemistry

Qualifications

• Ph.D. or equivalent with 10+ years in pharma analytical development.
• Experience leading analytical development teams and budgets.
• Expertise in cGMP, regulatory compliance, and SOPs.
• Strong publication/patent record and cross-functional influence.

Responsibilities

• Lead Analytical group and coordinate with site leadership.
• Direct management of Analytical resources and project budgets.
• Serve as primary customer liaison for project communications.
• Oversee quoting, budgeting, invoicing, and reconciliation.
• Maintain knowledge of regulatory guidelines (FDA, ICH, USP).
• Foster teamwork and drive finish-aligned programs on time.
• Provide technical expertise and mentorship across teams.

Skills

Analytical Chemistry

Communication skills

Leadership / Mentoring

Cross-functional collaboration

Project management

Education

Ph.D. in Analytical Chemistry

MS in Chemistry

BS in Chemistry

Tools

HPLC

GC

LC/GC-MS

IR

Job description

#2675 Director Analytical Research and Development

Transformational Position Alert

Global pharmaceutical company seeks technical subject matter expert in drug substance development who also can lead a team from clinical to commercial capabilities

Director 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. Experimental skills related to Analytical development and technologies are a must. Serve as a principal subject matter expert to the company.

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

• 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
• Demonstrated ability to operate independently while aligning to organizational priorities and achieving key business objectives
• Strong commitment to talent development, including coaching, mentoring, and building high-performing teams through effective knowledge transfer

Experience 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