- LOCAL APPLICANTS ONLY*
- NO C2C*
Job Summary :
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.
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