Lead Engineer I - Process Development

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$90,000 - $120,000
Job Type
Direct Hire
Aug 13, 2018
Job ID


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.  


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