Provide analytical expertise and leadership in the development of drug substances and pharmaceutical products from early development through commercialization. Plan analytical research and development activities, devise strategies for achieving project goals and independently manage CMC timelines. Make pivotal contributions to drug product development strategy at project team level. Independently manage multiple projects and ensure timely delivery of all deliverables to meet project milestones and goals. Originate novel approaches to solve experimental problems and generate novel experimental protocols. Design, manage, lead, and implement analytical development activities to support all stages of drug development, including drug substance and drug product development. Supervise, mentor and direct the work of assigned staff. Oversee and coordinate analytical development activities in-house and at contract labs and ensure quality and timeliness of work. Provide leadership, direction and analytical support for investigations and troubleshooting analytical issues. Design stability studies to support shelf life and storage statements for drug substance and drug products. Propose and justify specifications for drug substance and drug product. Review and approve analytical data, technical protocols/reports and analytical methods in support of regulatory CMC filings. Author and review relevant sections of IND's and NDA's and prepare responses to CMC questions from regulatory agencies. Identify, evaluate, recommend, and purchase new equipment to meet project needs. Develop, review, and approve standard operating procedures to satisfy cGMP and corporate requirements. Collaborate with cross-functional groups to meet drug development milestones. Lead CMC Teams as required. Lead and/or contribute to various departmental and cross-functional teams as assigned. Keep current in analytical research including literature and technology advancement. Investigate new technology and research opportunities. Publish and give presentations at both internal and external meetings. Provide training and coaching to staff for their career development. Contribute to department and lab management strategies and activities.
Main Areas of Responsibilities
- Plan analytical research and development activities, devise strategies for achieving project goals and independently manage CMC timelines. Makes pivotal contributions to research technology and/or the development of products. Originate novel approaches to solve experimental problems. Generate novel experimental protocols. Design experiments to generate analytical data to contribute to technical feasibility reports for strategic planning and evaluating commercial value of project proposals. Troubleshoot and solve analytical problems to assure timely completion of projects and technical reports to meet CMC project timelines. Supervise laboratory experiments to demonstrate method suitability for application to drug substances and products analyses from early development through commercialization. Supervise and actively contribute to developing, validating and transferring analytical methods to meet the committed timelines and resolve any technical issues to assure effective transfer. Proactively interact with appropriate scientists of customer departments on complex project issues to arrive at satisfactory resolution of problems.
- Author and review relevant sections of IND's and NDA's and prepare well written responses to CMC questions from regulatory agencies. Review and approve CRO and in-house generated analytical data, technical protocols/reports and analytical methods in support of regulatory CMC filings. Interact with department head for review of, and agreement/consensus on critical documents. Develop the design/strategy for drug or product stability studies. Propose and justify specifications for drug substance and drug product. Recommend retest/shelf life and storage conditions based on sound technical data and regulatory guidance. Apply appropriate statistical testing and modeling to generate shelf-life calculations, data pooling, etc., per regulatory guidelines. Ensure generation of high quality scientific data and documentation by group members.
- Provide oversight on analytical aspects of outsourced programs to ensure the work is performed according to company’s technical standards and expectations. Interact and negotiate with CRO’s/CMO’s and define contract activities/cost and identify analytical deliverables. Plan and direct activities at contract labs (for drug substance, formulation, and analytical) and ensure quality of work and timely delivery of results for assigned CMC projects. Troubleshoot and solve analytical problems to assure timely completion of project deliverables. Actively participate with and provide technical support to CRO’s/CMO’s for OOS/OOT investigations. Direct laboratory testing at CROs as required to ensure that all data are accurate and reliable and are generated in an accurate and timely manner. Plan and manage the budget effectively to meet company targets. Accountable for ensuring that staff members plan, initiate and direct outsourced projects to meet timelines, and manage the budget effectively.
- Supervise a group to conduct analytical development activities to support all stages of drug development including drug substance and drug product development. Provide directions to direct reports at all stages of development and post-commercialization. Provide direct reports training, technical guidance and support to resolve project technical issues satisfactorily within target timelines. Coach and mentor all direct reports for their continuous development and improvement of scientific skills. Able to assess the resource needs of a team and plan accordingly. Manage laboratory workload and resources efficiently to ensure meeting target turn-around times, quality of data and accurate and timely documentation.
- Proactively maintain state-of-the-art knowledge in current pharmaceutical and analytical sciences related to drug development. Make presentations at departmental, Pharmaceutical Development scientific meetings, and external scientific meetings. Publish scientific papers and give presentations at both internal and external meetings. Attend pertinent scientific conferences, workshops and technical training sessions to learn and bring in knowledge. Recommend new technologies to the department management and proactively introduce them to the department.
- Plan and manage project-related and capital budgets to meet company targets. Assist in recruiting, budgeting, laboratory management, instrument selection and purchase; demonstrates clear initiative in continuous improvement of department’s performance metrics and efficiency of laboratory operation. Ensure that cGMP SOPs, safety and corporate policies are adhered to and optimum performance is achieved.
- Provide leadership to drug development CMC teams as assigned. Actively participate on CMC project teams and provide technical support to development of projects. Provide strong project planning and experimental design. Coordinate the development activities of CMC teams through all phases of drug development. Independently manage CMC timelines. Contribute to drug development teams to meet project milestone. Work with department head to develop strategic guidance and/or directives to support development and commercialization of product. Coordinate with the process and product development representatives from CMC teams to ensure analytical development needs are met (internal or external support), and to establish appropriate control strategies. Assure timely communication of project activities to project teams and management.
The following listed requirements need to be met at a minimum level to be considered for the job:
- Minimum 8 years of related pharmaceutical industry experience in the development of analytical methods to support drug development and product registrations
- Experience in directing the work of experienced scientists and professionals both in a development setting and in a cGMP environment
- Thorough knowledge of worldwide CMC regulatory requirements and experience in authoring relevant CMC sections of INDs and NDAs
- Experience in working with contract labs and manufacturing sites to transfer methods and technologies, and trouble shoot quality related issues
The below skills are attributes that may not be mandatory but are strongly desired in the ideal candidate:
- Expert knowledge of theory and hands-on experience of various analytical instrumentations (e.g., HPLC, GC, LC-MS, GC-MS, Dissolution, UV/Vis, FTIR, titrators, etc.). Strong knowledge and hands-on experience with various sample preparation techniques, as well as experience with basic repair and maintenance techniques for laboratory instrumentation are required.
- Expert ability to develop and verify analytical methods and specifications for drug substances and drug products for drug development and commercialization. Expert ability to evaluate and interpret analytical results (including stability data) leading to recommendations regarding product quality. Strong ability to provide guidance and coaching to associate level staff in this area. Ability to troubleshoot experimental problems and lead investigations to resolve analytical issues is required.
- Knowledge of drug development process. Experienced in organizing and leading CMC teams through the development process. Strong skills in planning research activities and devising strategies for timely achieving project goals.
- Experience with extended drug release dosage forms. Development of accelerated in-vitro tests, design of experiments for evaluating discriminatory power of test methods and specification strategies.
- An education level of a Ph.D. (or equivalent experience) in Analytical Chemistry, Pharmaceutics, Pharmaceutical Chemistry or Organic Chemistry