R&D Manager - Specialty Products
Job Details
Management
Scientific Protein Laboratories - Waunakee, WI
4 Year Degree
Day
Description

Scientific Protein Laboratories is a biopharmaceutical leader in the development and manufacturing of cGMP-compliant products including pancreatic enzymes and heparin. Lately, SPL has embarked in a new direction of expanding and diversifying its product portfolio and pipeline by actively investing in new technologies and products including both external partnerships and internal development efforts.  We have an immediate opening in Waunakee, WI (Madison area) for a Manager of Specialty Products to join our growing R&D Specialty Products Business team.

This position is responsible for leading and managing manufacturing activities for new and existing internal specialty products and external contract development. The Manager of Specialty Products works with R&D Development and Engineering to scale-up and implement manufacturing processes for new products and maintain cGMP compliance.  This role also interfaces with Production, Quality, and Sales and Marketing Departments. The Manager of Specialty Products reports to the Director of Specialty Products Business.

Duties and Responsibilities

  • Lead the Specialty Products Operations group including R&D Technicians and R&D Specialists (note: the Supervisor level does not lead the R&D Specialists).
  • Lead and manage resources and timeline for contract development and manufacturing activities upon transition from R&D Scientists. Activities include but are not limited to process scale-up, specifying new equipment, working with outside equipment vendors, preparing mass balances, analyzing processes, and preparing process flow diagrams.
  • Manage the operation and cGMP compliance of the R&D/Specialty Products department laboratories and manufacturing facilities, including collaborating with Quality and Validation.  Interact with Specialty Products Business customers on contract development and manufacturing projects. 
  • Recruit, train, coach, and develop staff skills, including technical, writing and communication skills. Interview and hire new employees, recommend promotion or disciplinary actions.  Order equipment and supplies required by production, perform general lab maintenance which is required of all R&D employees.
Qualifications
  • Bachelor’s or Master’s Degree in engineering, chemistry, or biological sciences is required (Supervisor level requires Associate’s degree or above in engineering, chemistry, biological or related sciences)
  • Minimum 5+ years of experience. 10+ years of experience preferred
  • Must have working knowledge and hands-on skills related to protein purification, process development and scale-up. 
  • Demonstrated experience in pilot scale cGMP operation is highly desirable. 
  • Experience, in a pharmaceutical manufacturing and/or research setting, is highly desirable. 
  • Experience with new industry guidance and regulations is highly desirable.

 

 

SPL offers a competitive salary, a comprehensive benefits package and a pleasant work environment.

EOE

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