cGMP Operations Lead – 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 immediately seeking to fill a new role in a growing team dedicated to developing non-carrier added lutetium-177 for cancer therapies.  The person in this role will be the lead production operator, working in our cleanrooms to produce our products.  This person will use their experience to work with the development team to build robust manufacturing operations and then lead routine production of Lu-177.  As the team grows, this individual will gain direct reports and supervise others to assist in production.  This individual will help with everything from receiving raw materials, processing radioisotopes in production hot cells, preparing the sterile API and shipping the API to our customers.  In addition, this person will help guide design of a new cGMP facility.  This is an amazing opportunity for someone with a diverse background to join our team and help build our manufacturing operations as we start with clinical production and grow into commercial production.  A strong background in pharmaceuticals/APIs or medical devices is required and work with radiopharmaceuticals is preferred.  This is a strong team environment and our operations lead/supervisor must work well between all departments.  This is a fast-paced product development cycle to help cure some life-threatening forms of cancer and we are looking for team members that fit well into this environment.

Duties and Responsibilities:

  • Responsible for production of cGMP products, executing batch records, running equipment
  • Develop procedures and draft documents for operations including SOPs, batch records and forms
  • Lead the production of radiopharmaceutical product including set-up, operations and end of production cleaning
  • Cleaning and preparation of the cleanrooms
  • Aseptically filling and sealing vials
  • Assisting in development and validation activities
  • Training and mentorship of other manufacturing operations staff
  • As team grows, supervisory management of other operations team members
  • Assist other projects and departments, as required
  • Some travel may be required
  • Overtime may sometimes be necessary to complete required work assignment with little or no advance notice

Qualifications:

  • Degree in engineering or scientific discipline or comparable experience
  • Minimum 7 years of equivalent experience
  • Pharmaceutical or API manufacturing experience required
  • Radioisotope production experience preferred
  • Aseptic experience preferred
  • Experience drafting documents such as SOPs and batch records required
  • 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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