Job details
Job type full-time
Full job description
When you join us at thermo fisher scientific, you’ll be part of a smart, driven team that shares your passion for exploration and discoveryWith revenues of more than $24 billion and the largest investment in r&d in the industry, we give our people the resources and opportunities to make significant contributions to the world.
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 clientsOur employees are committed to making a difference in our organization, for our client partners and the patients we serveWe 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 staff data scientist/statistician 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 sitesThe staff data scientist/statistician will collaborate with cross-functional teams to design and develop robust and reliable data monitoring and visualization tools to meet and/or exceed client delivery commitmentsThe staff data scientist/statistician will be responsible for developing the statistical tools for the continuous process verification (cpv) program at each of the vvs commercial manufacturing sitesThe statistician/ lead data scientist will provide in-depth statistical and data analytical expertise to across the vvs organization by partnering with process development, quality control, quality assurance, manufacturing, and process sciences groupsThis position will play an important role when interfacing with external clients, providing expertise and guidance, as needed.
What will you do?
Provide statistical expertise 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.
Independently analyze data, make conclusions and present findings for multiple internal teams and client programs.
Must stay current with relevant technologies and forward thinking to identify new approaches to meet the evolving business needs.
Train mst in basic statistical techniques and appropriate data analysis tools.
Utilize analytical, statistical, and programming skills to collect, analyze, and interpret large data setsThey then use this information to develop data-driven solutions to difficult business challenges
Lead the development of statistical and data visualization tools to meet the strategic vision of the global mst team
Provide expert statistical data analysis during deviations investigations, change controls and experimental studies.
Work with counterparts in vvs’s alachua process development, cambridge and lexington manufacturing, quality, project management teams etcTo facilitate project success
Implement process monitoring, statistical techniques and concepts to ensure process are running in a state of control.
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 fieldPhd preferredB.sWith 8+ years’ relevant experience, or master’s degree with 6+ years’ relevant experience, or phd with 4+ years’ relevant experience.
Skills and 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
Thermo fisher scientific incIs the world leader in serving science, with annual revenue exceeding $25 billionOur mission is to enable our customers to make the world healthier, cleaner and saferWhether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support themOur global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including thermo scientific, applied biosystems, invitrogen, fisher scientific, unity lab services and patheonFor more information, please visit www.thermofisher.com.
