Director Analytical Research and Development

Cambrex; High Point (NC); On-site; USD 180,000 - 240,000; Full time

Job summary

Cambrex is hiring a Head of Analytical Research and Development. This role leads a high-level analytical team responsible for drug substance development and manufacturing support with a focus on cGMP and regulatory readiness.

The position requires a Ph.D. in Analytical Chemistry with extensive leadership experience, and deep expertise in analytical methods for APIs, with global client interactions and project oversight. Based in the U.S., NC region preferred.

Qualifications

• Ph.D. in Analytical Chemistry with 10+ years of relevant experience; MS with 15+ years or BS with 20+ years also acceptable.
• Management experience in pharma chemical development or manufacturing.
• Strong knowledge of quality control, regulatory compliance, scheduling and execution.
• Experience in SOP development and SOP implementation across teams.
• Technical expertise in analytical chemistry and ability to advise cross-functional teams.

Responsibilities

• Lead the Analytical group incl. Associate Directors and senior scientists.
• Direct management of Analytical resources and project priorities.
• Serve as primary customer contact for project communications.
• Coordinate with R&D, PM, and other groups on progress and resources.
• Oversee project quoting, budgeting, invoicing, and reconciliations.
• Promote project results within the group and to customers.
• Maintain up-to-date knowledge of analytical chemistry and cGMP regulations.
• Ensure compliance with FDA, ICH, USP, EP, JP guidelines.
• Foster teamwork, safety, and a can-do department culture.
• Plan long-range strategy with site management and leadership.

Skills

Leadership

Project management

Analytical chemistry

Cross-functional collaboration

Communication

Data analysis

SOP development

Strategic thinking

Team development

Regulatory knowledge

MS Office

Education

Ph.D. in Analytical Chemistry

M.S. in Analytical Chemistry

B.S. in Chemistry or related

Tools

HPLC

GC

LC/GC-MS

IR

Job description

You Matter to Cambrex.

Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance development and manufacturing across the entire drug lifecycle, as well as comprehensive analytical and IND enabling services.

Company Information

You Matter to Cambrex. Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance development and manufacturing across the entire drug lifecycle, as well as comprehensive analytical and IND enabling services. With over 40 years of experience and a team of 2,000 experts servicing global clients from North America and Europe, Cambrex offers a range of specialized drug substance technologies and capabilities, including continuous flow, controlled substances, liquid-phase peptide synthesis, solid-state science, material characterization, and highly potent APIs.

Your Work Matters.

At Cambrex, we strive to build a culture where all colleagues have the opportunity to:

• engage in work that matters to our customers and the patients they serve
• learn new skills and enjoy new experiences in an engaging and safe environment
• strengthen connections with coworkers and the community

We’re committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company. We offer a competitive benefits package that includes healthcare, life insurance, planning for retirement, and more!

Your Future Matters.

Known for our customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world.

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. 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

• 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
• 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
• Ability to analyze complex data and insights from multiple sources to develop innovative, scalable solutions
• Demonstrated capability 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

This role is primarily performed in an office setting with regular interaction in laboratory and GMP manufacturing environments. Responsibilities require prolonged periods of sitting, computer use, and participation in meetings, along with occasional standing and walking between departments. The role requires visual acuity, verbal communication, and manual dexterity for reviewing data, reports, and presentations.

The position operates in a regulated pharmaceutical environment and may involve exposure to laboratory hazards, including chemicals and materials, when in controlled settings. Adherence to all safety procedures, including the use of appropriate personal protective equipment (PPE), is required.

Travel Requirements

This position requires occasional travel to support client engagements, site visits, audits, and collaboration across Cambrex locations. Travel is primarily domestic with occasional international travel, as required by business needs.

Cambrex is committed to providing a safe and productive work environment. All offers of employment are contingent on the successful completion of a comprehensive pre-employment screen. The pre-employment screen may consist of several components including but not limited to a drug test, criminal record check, identity verification, reference checks, education and employment verification, and may vary based on federal, state, and local laws. Refusal to submit to testing will result in disqualification of further employment consideration.

All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities. Cambrex Corporation is an Equal Opportunity / Affidjutive Action employer and will consider all qualified applicants for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), ancestry, national origin, place of birth, age, marital status, disability/handicap, genetic information, veteran status, or other characteristics protected by federal, state, and/or local law.