Director of Manufacturing Chemistry

Job Description

The Director of Manufacturing Chemistry ensures Chemistry manufacturing processes are safe, scale-appropriate, compliant, in control, and continuously improved with strong collaboration from Process Development, Quality and EH&S. The incumbent will be responsible for leading a team that provides technical support for manufacturing readiness, EH&S compliance, and manufacturing operations through strong technical and cGMP input, establishing manufacturing standards to enable robust, safe and scalable manufacturing. The scope of this position includes leading a team of manufacturing process subject matter expert (SME), providing technical support for process development and scale up, technology transfer, process and equipment qualification, technical support during manufacturing.

Responsibilities

• Lead of team of manufacturing associates in the execution of manufacturing of chemical processes

• Support efforts related to transfer of chemical manufacturing technologies from process development to cGMP manufacturing

• Develop talent and to achieve results through teamwork and leadership of others, streamlined execution, and innovation in a matrix business unit environment

• Remain responsible for the transfer of technologies, including cross-department and client collaboration to enable facility fit, development of process documentation (Batch Records, Forms, SOP etc.), Change Control ownership, Investigations, and other quality system deliverables.

• Recommend strategies for improving manufacturing processes for top performance using sound engineering and scientific principles.

• Lead process control strategies development, including execution of process risk assessment, process parameters range justifications, and criticality assessment.

• Provide a science-based approach for the resolution of deviations, investigations, and process issues through analysis of product development studies and data.

• Network with Process Development and Quality organizations to establish a reliable state of process control.

• Provides training as needed and ensures adherence to company policies and quality requirements.

• Ensures budgets, schedules, and performance requirements are met as they pertain to client deliverables

• Improve product quality and cost and reduce customer complaints through a proactive program that includes interaction with internal and external suppliers. Utilize collected data from customers to enhance perceived product quality.

• Assess and implement measures to detected and de-risk safety concerns inherent to the manufacturing processes and operations

• Establish lean practices and a continuous improvement mindset throughout operations and the direct supporting organizations.

• Operate to the highest ethical and moral standards. 

• Adhere to quality standards set by regulations and policies, procedures, and mission.

• Communicates effectively with supervisors, colleagues, and staff.

• Ability to participate effectively as a team player in all aspects of business.

• Performs other duties as assigned

Qualifications

• Degree in Organic Chemistry or Chemical Engineering, or a master’s degree with equivalent experience. PhD in organic chemistry or chemical engineering preferred

• 10 years of relevant industry experience as a minimum, with 15 years preferred

• Chemist by training, with experience in process scale up from development to manufacturing

• Process development experience with a focus on scale up product isolation

• Experience in managing direct reports and leading projects

• Knowledge of process safety

• Experience with process transfer and scale-up from R&D to a GMP environment

• Skilled or experienced in analytical techniques

• Late phase process development experience is preferred