Lead a non-sterile product team and operations, including managing the solid dosage form portfolio business processes, budget, and employee development. Provide technical direction and oversight for engineering of new non-sterile products. In collaboration with the sterile dosage form group lead, influence the enhancement of processes, methods, and procedures for development of the cross-modality portfolio of products. Provide leadership in the establishment and gathering of metrics, procedural updates, and business systems development. Work in collaboration with drug substance, drug product, and analytical functions to ensure thorough engineering and packaging science are applied to deliverables. Build talent and provide proactive support in training and coaching team members. Remain informed of current GMP requirements and industry trends as described in worldwide regulations and industry standards. Maintain an active network of practitioners and resources in relevant fields of expertise. Demonstrate financial stewardship in all areas of responsibility.

• Lead a group of colleagues of various levels and provide both strategic and tactical leadership to the group in managing assigned projects. Ensure resource allocation to provide timely analytical support to process development, clinical manufacturing and stability studies. Provide technical guidance, top-level evaluation of method development, validation and implementation of analytical methods for intermediate and final drug products. Ensure compliance of cGMP, laboratory safety, and environmental policies. Provide a leadership role in building efficiency, managing staff and resolution of broader operational issues. Oversee, lead or participate in the Quality Risk Assessments. Oversee the authorship of the analytical sections of regulatory filings and subsequent response to questions Provide coaching, training, guidance, and assist in developing priorities for direct reports as well as track and evaluate performance. Assist in developing goals and priorities for the department. Communicate and interact both intra- and inter-departmentally to enable execution of initiatives, projects, and setting of priorities. Recruit and interview staff for positions and make recommendations for hiring. Manage identification, assessment, and implementation of new instrumentation and analytical technologies.

• Work as an individual contributor and team leader in the development and utilization of characterization techniques to support product formulation and process development for drug products. Responsibilities include: o Analytical method development and validationo Analytical investigationso Product and process characterizationo Registration specification developmento Drug product stability studieso Shelf life establishment o Process scale-up and process validation supporto Preparation of relevant CMC documents for global registration• Work closely with other technical, regulatory, research, and manufacturing teams comprising scientists and non-scientists to effectively coordinate drug product development efforts and lead the progress for multiple projects. • Coach/mentor other scientists and build/maintain the scientific capabilities of the organization.