Provides technical input and support for the internal team and the customer. Interacts with customers and works with internal team to set timelines, understand and schedule work requests, define and resolve issues, and communicate results. Recognizes and solves complex, non-routine analytical and product problems independently.
Provides technical leadership in the application of analytical sciences to the development of customers’ pharmaceutical products. Provides leadership in project teams and customer relationships. Manages multiple projects and day-to-day activities while contributing to a team atmosphere.
Leads the development of quality products through participation and representation on group and department level project teams and mentoring junior team members. Advises on current best practices, challenges, and industry trends
Attends customer meetings and is the analytical technical representative to set timelines, understand and schedule work requests, define and resolve issues and communicate results.
Clearly and accurately communicates the results of work by creating documentation of the testing and obtained results. Reports results in accordance with prescribed lab procedures and systems. Acts as the main contact and interacts with customers directly.
Provides technical input and approval of method validation documents related to test methods for strength, impurities, identity, and dissolution by HPLC, GC, dissolution, spectroscopy, and traditional quantitative analysis, utilizing HPLC, GC, LC/MS, dissolution, spectroscopy, and traditional wet chemical testing.
Contributes to the preparation and filing of project regulatory documents. Communicates with outside departments, corporate sites, and customers.
Participates and contributes to safety programs, department and customer meetings, and in maintaining an orderly and safe laboratory environment.
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.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.