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Cambrex

Global CDMO for drug substances

Director Analytical Research and Development

Bioprocess & BiomanufacturingConfirmed live in the last 24 hours
Full-timeHigh Point, NC, USANo salary listed

About the Job

Requirements

  • 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.
  • Strong organizational and problem-solving capabilities, with a focus on delivering results in dynamic, fast-paced environments.
  • Proficiency with Microsoft Office applications, including Word, Excel, and 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.
  • Ph.D. in Analytical Chemistry or a related discipline with a minimum of 10 years of relevant experience; alternatively, an M.S. with 15 or more years or a B.S. with 20 or more 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, including HPLC, GC, LC/GC-MS, and 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.
  • Expert knowledge of laboratory personal protective equipment expectations.
  • Thorough knowledge of and experience working under current Good Manufacturing Practice (cGMP) regulations.
  • Excellent publication and patent record.
  • The role requires visual acuity, verbal communication, and manual dexterity for reviewing data, reports, and presentations.
  • Adherence to all safety procedures, including the use of appropriate personal protective equipment (PPE), is required.

Responsibilities

  • Work closely with the Site Head, the Senior Director of Chemical Development, the Senior Director of Quality, and other site leadership to ensure successful completion of ongoing work.
  • Lead and manage programs according to established and adjusted timelines.
  • Directly manage all Analytical resources.
  • Serve as the 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.
  • Prepare project quotes, budgets, invoices, and reconciliations.
  • Manage customer interactions, including project discussions and updates, customer visits, contract negotiations, and dispute negotiations.
  • Actively promote the results of scientific projects within the group and to customers.
  • Maintain current knowledge of state-of-the-art chemistry, analytical chemistry, technology, and cGMP regulations, and apply this knowledge to daily problems and ongoing work activities.
  • Maintain current knowledge of regulations and guidance applicable to analytical testing and characterization of pharmaceutical products, including FDA, ICH, USP, EP, and JP requirements.
  • Maintain a spirit of teamwork and cooperation within the department.
  • Use expert knowledge of Analytical Chemistry as a resource for the company and its customers.
  • Manage projects and ensure timelines are met.
  • Work closely with other site management to provide long-range business planning and guidance.
  • Organize the workload of Analytical group personnel by coordinating with Analytical Associate Directors and Analytical project managers and leaders.
  • Prepare and review proposals for new and existing projects, and manage projects as needed.
  • Serve as a principal subject matter expert to the company.
  • Perform experimental work related to Analytical development and technologies.
  • Perform the role primarily in an office setting, with regular interaction in laboratory and GMP manufacturing environments; work includes prolonged sitting, computer use, and meetings, with occasional standing and walking between departments.
  • Support client engagements, site visits, audits, and collaboration across Cambrex locations through occasional domestic and international travel.

About the Company

Cambrex

Global CDMO for drug substances

Cambrex is a global contract development and manufacturing organization (CDMO) that provides drug substance development and manufacturing across the entire drug lifecycle, plus analytical and IND enabling services. It uses a range of specialized technologies—such as continuous flow chemistry, handling of controlled substances, liquid-phase peptide synthesis, solid-state science, material characterization, and production of highly potent APIs—to develop and manufacture drug substances for clients. The company differentiates itself with over 40 years of experience, a staff of about 2,000 experts, and a global footprint in North America and Europe, offering end-to-end capabilities from early development through commercial-scale manufacturing. Its goal is to help clients bring new medicines to market by delivering integrated, reliable drug substance development and manufacturing and related analytical support.

Company size
1,001-5,000
Company stage
IPO
Headquarters
East Rutherford, NJ
Founded
1981

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