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SHINE is immediately seeking a Senior Process Engineer for an exciting new role in a growing team dedicated to developing non-carrier added lutetium-177 for cancer therapies. This role will manage experimental design, work through challenges with physical and chemical separation techniques and focus on designing pharmaceutical production equipment. This person will draft test plans and process data while working with technicians to execute experiments. They will lead the process design activities to develop a pharmaceutical production process including equipment and facility. A strong background in pharmaceutical process design and/or radiochemistry is required, along with a desire to step into multiple roles as needed. This fast-paced development cycle will result in a product that will help treat certain life-threatening forms of cancer. We are looking for team members that will fit well into this environment.
Duties and Responsibilities:
Develops test plans, having the primary responsibility for planning and overseeing execution and documentation
Responsible for equipment and facility design activities
Champions cGMP activities and coaches others on proper techniques
Drafts production records, leads qualification planning activities
Works with contractors and consultants to achieve specific goals
Directs other scientists and engineers in developing equipment for processing and protection
Assists in all aspects of the production process from procurement to receipt, design, execution and chemical analysis
Responsible for maintaining laboratory functions and other routine tasks as required
Assists other projects and departments as required
Overtime may sometimes be necessary to complete required work assignment with little or no advance notice
BS in Chemical Engineering with at least 7 years of experience in cGMP pharma environment
Experience of nuclear process equipment and instrumentation a plus
Willingness to learn and understand new technology, instrumentation and technical processes
Ability to read from engineering drawings or schematics
Ability to follow written procedures and accurately record test data
Ability to work safely within an industrial and radiation environment
Travel may be up to 25% at times
Eligibility for employment is conditioned on the applicant’s ability to qualify for access to information subject to U.S. Export Controls. Additionally, applicant’s eligibility may be conditioned based upon meeting the Nuclear Regulatory Commission requirements for access to Safeguards Information, which typically requires a pre-employment drug screen, fingerprinting and criminal background check.
SHINE values diversity in all its forms as a critical component of innovation, which is fundamental to our success. Every member of the SHINE community benefits from the talents and experiences of our peers, from the mutual respect we exercise, and from the responsibility we take for our actions.