Lead Data Scientist/ Statistician

Thermo Fisher Scientific’s Viral Vector Services (VVS) is a rapidly growing, dynamic gene therapy contract development and manufacturing organization (CDMO) that is seeking sharp individuals to bring the highest quality processes, products and testing to our clients. Our employees are committed to making a difference in our organization, for our client partners and the patients we serve. We are looking for top talent with proven competencies and strong character to join our team and help lead our organization into the future.

Location

Cambridge, MA - A combination of onsite and remote is a possible option.

How will you make an impact?

The Statistician/ Lead Data Scientist of Manufacturing Sciences and Technology (MST) will be responsible for technical manufacturing support in accordance with current good manufacturing practices (cGMP) for VVS’s phase III/commercial manufacturing sites. He/she will provide analytical and statistical oversight to ensure robust and reliable production processes are established and maintained to enable the site to meet and/or exceed client delivery commitments. The Statistician/ Lead Data Scientist will partner with Process Development, Quality Control, Quality Assurance, Manufacturing, and Process Sciences groups to ensure collaboration. This position will also interface with external clients, providing expertise and guidance, as needed.

What will you do?

• Provide statistical leadership to process engineers, scientists, and associates for purification of late stage clinical, process validation and commercial stage products including overseeing the design of studies, investigation and data analysis of results, and writing/review of technical reports.
• Must stay current with relevant technologies and forward thinking to identify new approaches.
• Train MST in basic statistical techniques and appropriate data analysis tools.
  Utilize analytical, statistical, and programming skills to collect, analyze, and interpret large data sets. They then use this information to develop data-driven solutions to difficult business challenges
• Support Continued Process Verification allowing and associated documentation, as required.
• Manage investigation and data analysis to address deviation and implement change controls.
• Work with counterparts in VVS’s Alachua Process Development and Cambridge Manufacturing, Quality, project Management teams etc. to facilitate project success.
• Drive new process monitoring, statistical techniques and concepts to ensure process are running in a state of control and have alerts and SPC rules in place.
• Keep current on regulatory and quality requirements and follow Environment, Health & Safety policies.

How will you get here?

Education and experience:

A degree in in Statistics, Computer Science, Data Science or a related field. PhD preferred. B.S. with 8+ years’ relevant experience, or Master’s degree with 6+ years’ relevant experience, or PhD with 4+ years’ relevant experience.

• Experience with optimization and statistical data analysis tools.
• Strong project management and organizational skills
• Working knowledge of GMP and regulatory requirements of biopharmaceutical manufacturing is preferred.
• Knowledge of cell and gene therapy vector production highly desirable.
• Excellent troubleshooting skills and ability to solve complex technical issues.
• Understanding of guidelines required by FDA, EMA, and other regulatory bodies
• Excellent troubleshooting skills and ability to solve complex technical issues
• Strong interpersonal and communication skills, verbal and written

At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.