Leads a group of analysts who evaluate, develop and validate testing methods for in-process samples, finished products and stability samples. Develops and implements standard practices related to the method development process. Recognizes and solves complex, non-routine analytical and product problems independently. Interacts with internal clients to set timelines, understand work requests, define and resolve issues, assign and distribute work, and communicate results.
Provides leadership to assigned staff by performing the following: leading organizational change; developing and empowering staff; cultivating relationships; putting staff in a position to succeed, meeting their personal career goals while also achieving organizational goals; building effective teams that apply their diverse skills and perspectives to achieve common goals; driving engagement and creating a climate where staff are motivated to do their best.
Provides leadership in project teams and client relationships. Manages multiple projects and day-to-day operations while creating and maintaining a team atmosphere. Demonstrated ability to implement standard practices and manage with KPIs
Oversees the documentation of laboratory experimentation in protocols and technical reports. Reviews laboratory documentation for calculation, entry and GMP compliance.
Participates in regular communication with clients.
Represents the Development team in interdisciplinary site functional teams and supports the laboratory growth objectives
Participates and contributes to safety programs, department and client meetings, and in maintaining an orderly and safe laboratory environment.
Provides technical leadership in applications of analytical sciences to the development of clients’ pharmaceutical products.
Ensures team completes work according to department practices, Environmental Health & Safety (EH&S) practices, Standard Operating Procedures and other quality standards, as well as client expectations.
Receives assignments in the form of objectives and determines how to use resources to meet schedules and goals.
Guides staff to achieve tactical and strategic business goals; responsible for results including costing, methods, and staffing.
Ph.D. Degree in Analytical Chemistry, Pharmaceutical Analysis or a related discipline, or MS or BS with significant experience. Bachelor of Science in Analytical Chemistry, Pharmaceutical Analysis or related discipline. Strongly prefer MS or Ph.D.
Minimum of 8 years experience in the pharmaceutical industry, analytical development or quality control.
Equivalent combinations of education, training, and relevant work experience may be considered.
Ability to drive functional, technical and operational excellence. Ability to inspire and foster innovation, collaboration, tranparency and team effectiveness. Demonstrates analytical/scientific skills. Ability to help others develop skills required in a research and development environment and helps others understand potential and areas for improvement. Must have excellent communication skills, both oral and written. Knowledgeable in Good Manufacturing Practices. Excellent prioritization skills required.
Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pound pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.