Manufacturing Specialist

5 days ago


Lexington, Massachusetts, United States Genezen Full time
Job Summary

We are seeking a highly skilled Manufacturing Technician to join our team at Genezen. As a key member of our manufacturing department, you will be responsible for performing routine and non-routine manufacturing operations, including work functions in Cell Culture, Purification, Solution & Equipment Prep areas.

Key Responsibilities
  • Operate production equipment according to SOPs to produce clinical and/or commercial products.
  • Independently perform manufacturing of Genezen's therapeutic products and ensure this is realized and documented according to the highest industrial and GMP quality requirements.
  • Carry out cGMP manufacturing operations utilizing Standard Operating Procedures (SOP), Batch Production Records and Solution prep records.
  • Attend/run daily morning meetings and maintain orderliness of process area and stocking production area with supplies.
  • Execute routine and non-routine production operations according to MFG schedule and document operations according to GDP principles in Batch Production Record (BPR), Solution records (SLR), Logbooks and Forms.
  • Carry out work in a safe manner, notifying management of safety issues and risks, and provide Process & Equipment Training as a Qualified Trainer.
  • Maintain up-to-date training folder for applicable processes and manage equipment and support facility related projects.
Requirements
  • Associates degree in Life Sciences/Engineering field with 1 year of cGMP Manufacturing experience or BS degree in Life Sciences/Engineering field.
  • Ability to adhere to company internal and regulatory (EMA, FDA) policies, processes and procedures.
  • Works within standard operating procedures and/or scientific method, has a flexible attitude in a challenging environment, and good technical writing and oral communication skills.
What We Offer
  • 9 observed holidays + 1 floating holiday + 1 volunteer day.
  • ~401(k) plan with company match up to 6% of salary, vested immediately.
  • ~ Dental & vision care.
  • ~ Voluntary disability, universal life/personal accident insurance.

We are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare. We are dedicated to delivering quality results and upholding ethical principles, and we are committed to being a proactive, collaborative, creative and open-minded partner.



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