Principal Scientist - Process

The Principal Scientist - Process and Formulation Development is a significant contributor to CDMO client services from formulation development to process validation and continued product support. This individual will contribute to the quotation process, support on-site visits and tours, and lead teams to complete customer work per the timelines determined. This individual should be highly hands-on in formulation development and all equipment processed in solid oral dose manufacturing. Render technical expertise, and ability to scale processes from early development to process validation. Provide guidance and mentor junior scientists. Prior experience in ANDA/IND/NDA submission writing, and exceptional technical writing skills is a must. Excellent communicator and comfortable presenting technical data. Familiar with value stream processes/LEAN/Agile concepts are a bonus. Expert in solid oral dose manufacturing and new technology, knowledge of packaging of OSD products. Liquid/suspension experience is a plus.

• Understand and lead QBD approach to Early-Stage Formulation Development, leading formulation process evaluation early in the process development stage.
• Directly involved in successive phases of developmental and transfer activities including production of R&D/DOE batches, scale-up and registration.
• Provides leadership and work direction to junior level team members.
• Provide training and support to Operations personnel during the development and scale up of formulations on cGMP equipment.
• Understands and executes operation of pilot scale & commercial pharmaceutical manufacturing equipment without supervision. This includes managing the PD suites and equipment.
• Leads formulation process development, process scale up and technology transfer to commercialization throughout the product lifecycle.
• Through Product Lifecyle- ensure supply and business continuity by leading Continuous process monitoring, resolution of production issues and deviations, using Problem solving techniques.
• Manage change within the lifecycle of a product which would include component changes, API changes, excipients changes change controls, complaints and manage resulting process validation batches in a cGMP environment.
• Responsible for identifying and executing projects to reduce product cost, improve product quality, improve yield, reduce material usage, optimize productivity, yield, product quality, and supply reliability.
• Responsible for process technology training, SOP writing, technical reports and Validations, including perform statistical analysis of all study data.
• Supports quotes, site visits and tours for potential CDMO customers.
• Support internal, external and regulatory inspections including FDA, EMEA, and third-party inspections.
• Supports capital equipment URS and FSR for critical process equipment.

Requirements:

The position requires a minimum bachelor's degree in a scientific or technical field (pharmaceutical science, chemistry, chemical engineering, or a related life science), or an equivalent foreign degree, with at least 13 years' experience working in product development/manufacturing or process development/manufacturing in the pharmaceutical industry. Preferred Master' graduate degree in the above field, or an equivalent foreign degree, with a minimum of 10 years' of the above referenced experience. PhD graduate degree in a related field, with a minimum of 8 years of the above referenced experience. We also require at least 6 years' experience working with solid oral dosage forms, as well as 4 years' experience working with formulation process development, process scale up, technology transfer, or ongoing pharmaceutical commercial product support in a CDMO role. Experience can be gained concurrently. Previous leadership experience preferred.

Compensation Range:

Upsher-Smith Laboratories, LLC is committed to providing equal employment opportunity to all applicants and employees according to all applicable equal opportunity and affirmative action laws, directives and regulations of federal, state and local governing bodies and agencies. In keeping with this commitment, Upsher-Smith Laboratories, LLC will recruit, hire, train and promote persons in all job titles, without regard to race, color, creed, religion, sex (including factors related to pregnancy or child birth), national origin, age, marital status, familial status, disability, sexual orientation, gender identity status with regard to public assistance, employment status, local human rightscommission activity, status as a protectedveteran, genetic information, atypical hereditary cellular or blood trait, or any other protected category.