Mfg Scientist I/Sr Engineer I, Cell Banking – Mfg Sciences

  • Full-time
  • Region: US
  • Department: Manufacturing

Job Description

The Mfg Scientist I/ Sr Engineer I, Manufacturing Sciences will provide support within the Manufacturing Sciences (MS) Cell Banking group. As appropriate, responsibilities include:

  • Author and support regulatory filings, relevant to cell banking operations
  • Assist with external cell banking technology transfers, specific to Gene Therapy
  • Develop workflows for management of Gene Therapy cell banks and viral stocks 
  • Provide subject matter expert guidance relevant to cell banking during internal, partner and agency inspections
  • Execute cell bank growth characterization and stability laboratory experiments
  • Author cell bank manufacturing, growth characterization and stability technical reports
  • Provide technical support and assessments for cell bank deviations

Qualifications

  • Technical understanding of mammalian cell culture appropriate to cell banking operations
  • Excellent organizational, attention to detail, verbal and written communication skills
  • Ability to work independently and complete projects in an efficient and timely manner
  • Comfortable analyzing scientific datasets
  • Experience with change controls and electronic document management systems

Education:

  • Bachelor’s with 6 – 8 years of experience in chemical engineering, biochemistry, biology or similar or
  • Master’s with 4-6 years of experience in chemical engineering, biochemistry, biology or similar or
  • PhD with 0-2 years of experience in chemical engineering, biochemistry, biology or similar

 

Additional Information

The Mfg Scientist I/Sr Engineer, Cell Banking – Manufacturing Sciences, will provide technical expertise for the internal and external manufacture of cell banks.  

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