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Job Title: Contractor – Ph 2 Tech Transfer (Lyophilization), CMC

Job Number: 25350

Location: Lexington, MA

Job Description

We are seeking a highly motivated and scientifically rigorous individual to join our team to assist with the tech transfer of our Ph2 drug product to a lyo fill/finish CMO.   The position will focus on the tech transfer of drug product fill/finish, regulatory and analytical support. 

Responsibilities

  • Experience with Ph2 lyophilization tech transfer 
  • Experience working at/with a GMP fill/finish site 
  • Experience with lyophilization scale up with good understanding of scientific principles involved in lyophilization.
  • Familiar with analytical assays used for the release of lyophilized products. 
  • Experience working with multiple GMP mfg CMOs simultaneously
  • Prepare technical reports and presentations for clear communication of scientific findings and/or project updates across interdisciplinary teams

Required Skills

  • Bachelor’s or Master’s degree in Chemistry, Chemical engineering or engineering equivalent is desired
  • Minimum 10 years of experience working in a pharmaceutical or biotechnology company is required
  • Demonstrated leadership in tech transfer of drug substance and drug product processes is required 
  • Demonstrated ability to apply fundamental scientific and engineering skills for evaluation of processes and development of practical solutions to technical challenges is required.  
  • Must have experience working with GMP pharmaceutical manufacturing unit operations 
  • Strong familiarity with cGMP, ICH and regulatory guidelines 
  • Ability to partner with CROs/CMOs 
  • Desire to work in a fast-paced environment
  • Excellent organizational and communication skills 
  • Strong analytical and problem-solving skills

Translate Bio is committed to equal employment opportunity. All applicants must have authorization to work in the U.S.

 

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