Job Summary

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 position will have a strong emphasis on early-stage formulation and process development.

The Principal Scientist should be highly hands-on with extensive experience in oral solid dosage (OSD) formulation development, process development, scale-up, technology transfer and manufacturing unit operations. This individual will provide technical expertise in scaling processes from early development through process validation, troubleshoot complex manufacturing challenges, and serve as a technical resource for internal teams and clients. The role will also provide guidance and mentorship to junior scientists. Knowledge of analytical techniques is an advantage. Exceptional technical writing skills are required. The candidate must be an excellent communicator and comfortable presenting technical data and dealing with clients. Experience with value stream processes, operational excellence or Lean concepts is preferred.

The candidate must be an expert in OSD manufacturing and new technologies, as well as possess knowledge of packaging of OSD products.

This position is a hybrid role.

Essential Job Functions
• Understand and lead a QbD approach to early-stage formulation development, including formulation and process evaluation during the early stages of product development.
• Directly involved in successive phases of developmental and technology transfer activities, including production of R&D/DOE, scale-up, and registration batches.
• Develop and maintain process understanding by identifying product CQAs, defining CPPs, and establishing appropriate process control strategies throughout development, scale-up, technology transfer, validation, and commercial support.
• Possess strong technical knowledge of pilot-scale and commercial pharmaceutical manufacturing equipment and unit operations and provide hands-on support for development equipment and suites as needed.
• Lead formulation and process development, process scale up, and technology transfer through commercialization and throughout the product lifecycle.
• Lead technology transfer gap assessments by comparing processes, equipment, materials, controls, and site capabilities between the current manufacturing site and the receiving site. Identify potential technical risks or process differences and recommend actions to support successful transfer and implementation.
• Support supply and business continuity throughout the product lifecycle by leading continuous process monitoring, troubleshooting production issues and deviations, using problem solving techniques.
• Manage technical changes throughout the product lifecycle, including component, API, and excipient changes; change controls; complaints; and resulting process validation activities in a cGMP environment.
• Responsible for identifying and executing projects to reduce product cost and material usage and improve product quality, yield, productivity, and supply reliability.
• Responsible for process technology training, SOP and batch record writing, technical protocols and reports, including statistical analysis of all study data.
• Provide leadership and work direction to junior level team members.
• Provide training and support to Operations personnel during the development, scale up, registration, and other manufacturing activities on cGMP equipment.
• Support quotations, client site visits, and tours for potential CDMO customers.
• Support internal, external, and regulatory inspections including FDA, EMEA, and third-party inspections.
• Support identification of equipment needs based on process and customer program requirements.
• Assist Engineers in capital equipment URS and FSR for critical process equipment.

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions.

Minium Education & Experience 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 10 years of
• relevant experience in pharmaceutical product development, manufacturing, and/or process development.
• Master's graduate degree in the above field, or an equivalent foreign degree, with a minimum of 5 years of the above referenced experience.
• PhD graduate degree in a related field, with a minimum of 3 years of the above referenced experience.
• A minimum of 5 years of experience working with oral solid dosage forms, including experience in formulation and process development, scale-up, technology transfer, and/or ongoing commercial product support. Previous CDMO and leadership experience is preferred.

COMPENSATION RANGE

$142,000 - $190,000

Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies and experience.

Compensation and Benefits

We offer a comprehensive benefits package designed to support our employees' wellbeing, including:

• Competitive salary and performance-based incentives
• Comprehensive health coverage including medical, dental, and vision insurance
• Retirement savings plans with employer matching contributions
• Paid time off
• Professional development opportunities
• Employee wellness programs and resources
• Employee Assistance Program and Mental Health Resources