Job Description
Director Analytical Research and Development Cambrex - 3.3 High Point, NC Job Details Full-time 11 hours ago Qualifications Customer communication Drug regulation Schedule management Pharmaceutical analysis Materials analysis (analytical chemistry specialty) Laboratory standard operating procedures Regulatory/legal compliance standards in production Quality control within pharmaceutical industry Research regulatory compliance Manufacturing Chemical testing Legal compliance Cross-functional team management Pharmaceutical research Senior leadership
Full Job Description 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 Qualifications:
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
