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Senior Engineer - Process Development

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Location
Cincinnati, OH
Salary
$100,000 - $125,000
Job Type
Direct Hire
Degree
Bachelor of Science
Date
Jul 17, 2017
Job ID
2482905

The key duties of this role are to be the technical leader in late stage small molecule scale-up. The role will be responsible commercial start-up efforts as well as providing support for 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.
Provide technical leadership for start-up of new commercial process lines.
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.

QUALIFICATIONS:
PhD in Chemical/Mechanical Engineering and 5+ years of experience or MS degree and 10+ years of experience. Significant experience in development through GMP commercial batch manufacture, and scale-up/optimization of pharmaceutical products is required.

Experience:
Minimum 5 years of experience in process development, process engineering or related commercial scale-up/manufacturing in the pharmaceutical industry
Experience in leading/executing 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 preferred but not required