Engineering Manager – Therapeutics

at SHINE Medical Technologies
Location Middleton, Wisconsin
Date Posted September 16, 2020
Category Biotechnology
Job Type Full-time
Address 8123 Forsythia St, Ste 140

Description

SHINE is looking to fill an exciting new role in a growing team dedicated to developing non-carrier added lutetium-177 for cancer therapies.  The person in this role will manage a diverse team of engineers and scientists including nuclear, chemical, and automation engineers.  This person will guide the team through design of nuclear separation systems, automated process systems, aseptic operations and facility design.  This is a unique role managing various disciplines working to converge handling of radioactive materials comprised of complex chemistries in a cGMP environment.  Our product is intended for patient administration, so it must be sterile and made according to regulatory requirements.  Our manager will not only guide the team but may be asked to be hands on and work side-by-side with team members in the lab or production space.  A strong background in pharmaceutical process development is required and work with radiopharmaceuticals is preferred.  This is a strong team environment and our manager will be a key contributor to our success.  This is a fast-paced product development cycle to help cure some of life-threatening forms of cancer and we are looking for team members that fit well into this environment.

Duties and Responsibilities:

  • Responsible for a team of development engineers and scientists in the design of processes to produce radioisotopes
  • Develop and maintain schedules and budgets for project ranging from chemical processes to facility construction
  • Responsible for validation programs
  • Lead the design efforts for cGMP production including specification development and drawings
  • Ensure team focus by providing leadership, guidance, and inspiration
  • Develop team and provide mentorship
  • Assist other projects and departments, as required
  • Up to 25% travel may be required
  • Overtime may sometimes be necessary to complete required work assignment with little or no advance notice

Qualifications:

  • BS/MS/PhD in engineering or scientific discipline
  • Minimum 10 years of equivalent experience
  • Pharmaceutical process development experience required
  • Radioisotope production experience preferred
  • Experience with equipment qualification and process validation preferred
  • 2+ years management experience required
  • 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

Click here to learn more & apply today!

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