The Senior Engineer, Manufacturing Process Development position will play a crucial role in developing, optimizing, and scaling up manufacturing processes. This position requires a blend of scientific expertise, technical skills, and leadership abilities to drive manufacturing process development and improvements and ensure efficient, high-quality production practices are developed to support product development partnerships.
Responsibilities/Essential Functions:
Guide the development and optimization of manufacturing processes from small lab-scale to full GxP production at CDMO
Design and execute experiments to identify and improve process efficiency, yield, and product quality.
Analyze complex data sets and provide actionable insights to guide process development decisions.
Guide preparation and completion of development reports to summarize manufacturing development activities to:
Guide tech transfer of technology to CDMO partners for scale up.
Support development of Intellectual Property to assist company growth.
Collaborate closely with cross-functional teams, including R&D, Formulation, Quality Control, and Analytical as required.
Author and review technical protocols and reports, batch records, and standard operating procedures (SOPs) as necessary.
Troubleshoot process development issues and implement effective solutions.
Mentor junior scientists and technicians in process development techniques.
Ensure compliance with company quality standards.
Minimum Required Education and/or Experience
Educational training in Material Sciences, Chemical Engineering, Mechanical Engineering, Biochemistry, or related sciences field (degree commensurate with experience).
Minimum of 5 years of experience in biopharmaceutical process development.
Prior supervisory and project management experience leading technical operations development teams strongly preferred.
Strong knowledge of manufacturing and techniques.
Familiarity with quality by design (QbD) principles and process analytical technology (PAT):
Demonstrated expertise in design of experiments (DoE) and leading application of DOE in technical operations to support development strategies.
Understanding of analytical techniques and methodologies used for establishing quality control release specifications.
Experience with scale-up and tech transfer of manufacturing processes and interaction with CDMOs strongly preferred.
Excellent analytical and problem-solving skills and strong communication and interpersonal abilities are essential.
Strong computer literacy in relevant programs and ability to identify and summarize complex technical issues in written form is essential.
Ability to work effectively in a fast-paced, collaborative startup environment.
Experience with regulatory submissions and interactions with health authorities desired.