Associate Director, Small Molecule Product Development - Oral Products
Allergan plc (NYSE: AGN) is a bold, global pharmaceutical company and a leader in a new industry model - Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world.
Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective therapeutic categories. With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.
Allergan is a company that will inspire you to aim high with your ambition. Where you can build bridges all over the world. Where you can power ideas that drive change. And where you will act fast and drive results for customers and patients. Power your future & join our bold team.
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.
The employee must conduct their work activities in compliance with all Allergan internal requirements and with applicable regulatory requirements. Allergan internal requirements include compliance with ethics, environmental health and safety, financial, human resources and general business policies, requirements and objectives.
Furthermore, the position requires the individual to work with and in areas requiring select agents and Toxins access (i.e. Biosafety level 2 and biosafety level 3 laboratories). Access to and use of select agents is regulated by federal policies. Therefore, the candidate must conduct all work activities in compliance with Allergan internal and applicable regulatory requirements. Allergan internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives.
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 to analytical aspects of outsourced programs to ensure the work is performed according to Allergan'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.
Supervision, People Development and Workload Management
Supervise a group to conduct analytical development activities to support all stages of drug development including drug substance and drug product developments. 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.
CMC Team Leadership
Provide leadership to drug development CMC teams as assigned. Actively participate on CMC project teams and provide technical support to development 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 strategy. 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 and thorough knowledge of cGMP, FDA and international regulatory requirements.
* 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.). Thorough 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.
* Experienced in working with contract labs and manufacturing sites to transfer methods and technologies, and trouble shoot quality related issues.
* Thorough knowledge of worldwide CMC regulatory requirements and experienced in authoring relevant CMC sections of INDs and NDAs. Experience working in cGMP laboratories.
* Sustained record of publications or presentation or "publication quality" technical reports. Strong knowledge in current analytical techniques, technologies and methodologies.
* This position may require minimal travel.
* Ph.D (or equivalent experience) in Analytical Chemistry, Pharmaceutics, Pharmaceutical Chemistry or Organic Chemistry.
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