Stratus Therapeutics

Senior Manufacturing Associate

Watertown, MA
Full Time
Experienced

Position Title: Senior Manufacturing Associate 
Reports to: Director of Manufacturing 
Status: Regular, Full-Time, Exempt
Location: Watertown, MA

Company Summary: Stratus Therapeutics is pioneering a new era in regenerative medicine with Stratus Prime™ — an off-the-shelf platform delivering Prime HSCs™ and Prime HPCs™ to restore the blood and immune systems where finding fully matched donors continues to be a challenge. Backed by leading life sciences investors, we are committed to developing universal, on-demand stem cell solutions to give physicians and their patients the power to replace the entirety of blood and immune function. This commitment, along with an exciting team culture, drives our efforts to develop an off the shelf stem cell therapeutic platform.

Position Summary

Stratus Therapeutics is seeking a motivated Sr. Manufacturing Associate to support routine GMP Manufacturing operations. This includes day-to-day operational tasks including but not limited to, Materials Logistics, Cell Culture, and Environmental Monitoring within Stratus’ GMP manufacturing space. This role is located onsite, primarily in Watertown, MA with occasional work in Cambridge MA.  Some travel between sites is required.
 

Role and Responsibilities            

  • Perform, verify, and support GMP cellular therapy manufacturing activities
  • Support GMP materials release and labeling
  • Transfer materials into the GMP cleanroom suites following proper wipe down procedures.
  • Follow Personnel, Material, and Waste flow procedures related to GMP manufacturing of Cell Therapy products
  • Restock cleanroom manufacturing areas as needed.
  • Execute the environmental monitoring program as needed.
  • Perform deviation investigations and CAPA activities
  • Update SOPs and batch records as needed
  • Other related duties as needed

Qualifications and Education Requirements

  • Associates degree is required (in a science-related discipline preferred)
  • 3-5 years of experience in GMP Manufacturing for clinical or commercial use
  • 1- 3 years of professional work experience in a cell based therapeutic product is preferred
  • Strong interpersonal skills & attention to detail
  • Strong commitment to teamwork, collaboration, and professionalism
  • Proficiency in working with MS Office Suite
  • Able to handle a dynamic workload, multi-task, and perform effectively under tight deadlines
  • Must be able to lift 30 lbs

 
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