The Manager, Research & Development, is responsible for leading the R&D department in the definition and optimization of chemistry and reaction pathways for APIs, intermediates and final drug products for new business development opportunities and of analytical method development for new products. Through detailed knowledge of state-of-the-art and advanced concepts and technologies, recommends optimal API processes for further development. Manages the development and validation of analytical test methods for new product specific test methods. Ensures that development work completed by the department is completed in a scientifically sound manner and in accordance with the Cody Laboratories stage gate model in order to meet aggressive timelines for New Product Development activities.
Essential Duties and Responsibilities (other duties may be assigned):
• Lead, manage and coach the R&D department, consisting of the groups for chemical process development and analytical method development, in all their assignments, development.
• Provide guidance and oversight to ensure that newly developed manufacturing and product testing processes are state-of-the art, cost-effective, robust, and well-defined.
• Ensure that R&D resources are allocated appropriately to New Product Development project teams, that project deliverables are met, and that development is completed in accordance with ICH Q11 and company policies.
• Interact effectively with cross-functional teams, including Project Management, Product Development, QC, QA, Operations and other internal and external development groups.
• Conduct patent reviews and work with patent attorneys to ensure that future processes will have freedom to operate and that newly developed IP is appropriately protected.
• Conduct feasibility analyses to determine optimal processes for further development.
• Write, review, and/or approve scientific documentation, including development reports and regulatory documents in accordance with company policies.
• Perform complex laboratory activities including planning and performing experiments, including Design of Experiments, and research for novel processes to produce APIs.
• Ensure that analytical test methods used in R&D are scientifically sound and suitable for their intended use throughout the development process and that test methods intended for transfer into QC are able to be validated in accordance with ICH requirements.
• Conduct troubleshooting, participate in risk assessments, and provide technical assistance for NPD project teams, Operations, and Quality Control.
• Ensure that the R&D laboratory has supplies and organization to perform the assigned work, and is operated in accordance with OSHA, cGMP, DEA, and company policies.
• Detailed knowledge of state-of-the-art and advanced concepts, practices, and procedures within relevant fields and adapts or modifies experimental methods to achieve scientific objectives for application in industrial settings.
• Intense theoretical and practical knowledge in chemistry, organic synthesis, and process design and scale-up of pharmaceutical API and/or fine chemicals facilities.
• Strong leadership, coaching, and mentoring skills.
• Comprehensive expertise in pharmaceutical analytical test methods such as HPLC, GC, MS, pXRD, and NMR, including test method development and validation.
• Excellent organizational, interpersonal, and communication skills with demonstrated ability to coordinate departmental activities to meet objectives on time, on budget and with defined quality.
• Firm knowledge of Quality by Design and pharmaceutical regulatory requirements specified in 21CFR 210 and 211, ICH Q7a, ICH Q11, and other applicable ICH guidance documents.
• Must be highly self-motivated, well organized, and have strong analytical and problems solving ability to be able to develop alternative solutions to complex issues..
• Effective administration and technical writing skills, including ability to write protocols, design of experiments (DOEs) and other technical reports and documents.
• Actively promotes and personally observes safety and security procedures.
• Strong familiarity with MS Office applications, statistical analysis, and scheduling programs.
Ph.D. in Chemistry required; with at least 10 years of organic synthesis experience including at least 5 years in a leadership role. At least 3 years of experience in analytical method development and validation preferred. Research and Development experience in the pharmaceutical industry, specifically in the development of active pharmaceutical ingredients, strongly preferred.