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.