Seeking an engineer to lead projects in support of small molecule clinical and commercial manufacturing processes. The individual will design, develop, scale-up and optimize robust drug product unit operations that provide high product quality at various scales ranging from R&D to cGMP manufacture. Strong collaboration is expected with internal early R&D groups, internal commercial partners, and external third party CMOs. The candidate should have strong communication & interpersonal skills, be able to multi-task and have a commitment to continuous learning.
ESSENTIAL AREAS OF RESPONSIBILITY:
The key duties of this role are to be the technical leader in late stage small molecule scale-up. The role will be responsible for commercial support of investigations and identifying process optimization opportunities within commercial operations.
- This role is expected to have a strong lab/pilot plant presence: design and execute statistical studies with a focus on process understanding & robustness, interpret and present data, participate in cross-functional development teams, and author technical reports.
- Utilize theoretical and practical expertise to troubleshoot and resolve technical issues with experimental studies or commercial operations.
- Identify and implement process improvements into on-going commercial operations with emphasis on yield improvement and reducing process variability.
- Generate documentation to support process design and implementation activities within a cGMP environment.
- Support FDA pre-approval and post-approval inspections by serving as technical expert for development and processing operations. Present, where appropriate, technical data to internal or external audit groups and commercial partners.
- Build strong relationships with internal and external stakeholders and take advantage of these relationships to identify new opportunities.
- Ensure all company and departmental policies and procedures are adhered to and follow cGMPs/cGLPs.
PhD in Chemical/Mechanical Engineering and 0-2 years of experience or MS degree and 3+ years of experience. Experience in development through cGMP commercial batch manufacture, and scale-up/optimization of pharmaceutical products is preferred.
- Experience in product development programs for early phase development through commercial validation/launch
- Experience in technology transfer of process to commercial facilities
- Demonstrated technical expertise for developing new and existing technology based pharmaceutical processes, ensuring a high level of technological competency
- Experience in a Process Development environment using PAT and a fundamental understanding of Quality by Design methodology in developing GMP processes
- Sterile and/or aseptic processing experience