Director, Chemical Engineering R&D

Job Description

Description: 

The Director of Chemical Engineering R&D is responsible for managing a portfolio of projects from our Company's clinical pipeline, including oversight of laboratory-based process development and characterization, pilot plant scale-up and activities to support technology transfer and regulatory filings. The incumbent will be responsible for the performance and professional development of staff members within their group. In partnership with counterparts from Process Chemistry, Analytical R&D, and our Company's Manufacturing Division, the role is responsible for ensuring that innovative, robust, safe and economical processes are developed and launched for the small molecule pipeline with the best science at first filing towards world class supply targets. In addition, the Director participates in network wide activities within Small Molecule Process and our Research & Development division for setting strategic direction on the pipeline and other priorities, as well as helping to prioritize resource allocation. 

Nature and Scope of Position:
The Director reports to the Executive Director, Head of Chemical Engineering Research & Development, Small Molecule Process Research & Development. This Director role is responsible for the performance and professional development of approximately 15 staff members, including both scientific supervisors and R&D engineers. The incumbent will be responsible for helping to recruit, as well as for appraisal and development of personnel under their supervision. In addition, the Director will actively demonstrate and encourage diversity and inclusion principles in their approach to problem solving and talent development.

Critical tasks involve technical and strategic oversight of chemical engineering staff who directly contribute to the development, characterization and scale-up of various unit operations for manufacturing processes, including batch and continuous reactions, crystallizations, extractions, membrane separations, distillation, filtration and drying. The developed processes are ultimately demonstrated and validated at internal and external commercial supply sites and documented in technology transfer documents and regulatory filing submissions. The role maintains awareness of external factors, internal and external contacts and expertise requirements needed to solve challenging technical problems.  The Director influences the strategic direction of drug development and contributes to program Line-of-Sight (LOS) plans and Integrated Development and Supply Plans (IDSPs). This role directs technical and strategic work supporting their projects and provides input and guidance to reports including use of best practices and appropriate approaches to optimize resource utilization, as well as novel ideas or innovative approaches to technical or strategic advancements of programs. The incumbent will keep abreast, and encourage sharing, of discoveries in the field to ensure our Company remains an industry leader in drug development. The Director provides constructive and timely feedback to close performance gaps. In addition, the role ensures that all team activities are completed with the highest regard for safety, quality and regulatory compliance.

The scope of the role may also involve the oversight of the department’s specialty groups, such as the crystallization lab (Xlab) or the Environmental Process Safety and Engineering (EPSE) teams.

Qualifications:

Required:

• BS in Chemistry or related science with at least 12 years of pharmaceutical process development experience with a proven track record in small molecule commercial process development, scale-up, and technology transfer to manufacturing 

• MS in Chemistry or related science with at least 10 years of pharmaceutical process development experience with a proven track record in small molecule commercial process development, scale-up, and technology transfer to manufacturing

• Ph.D. in Chemistry or related science with at least 8 years of pharmaceutical process development experience with a proven track record in small molecule commercial process development, scale-up, and technology transfer to manufacturing

• Experience with authoring regulatory submissions and responding to regulatory questions

• Demonstrated ability in leading cross-functional groups

• Track record and commitment to employee development/retention

• Excellent interpersonal, communication, and collaboration skills

• Strength in delivering results on firm deadlines

• Demonstrated ability in selection and prioritization of a portfolio of projects

Location:

Rahway, NJ location is required

Required Skills: