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Plainville, Massachusetts, United States
Onsite
Work Schedule
Standard (Mon-Fri)Environmental Conditions
Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)Job Description
As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
Reporting to the Plainville, MA site and supporting the Viral Vector Services (VVS), a division of Thermo Fisher Scientific. At VVS, we deliver from process development through commercial supply, offering the expertise and resources vital to help clients deliver innovative gene therapies. We are placed at the forefront of our leading and groundbreaking Cell and Gene Therapy business, enabling clients to cure genetic, rare, and otherwise untreatable diseases.
Join our team as a Manufacturing Sciences Scientist II, where you'll contribute to ensuring consistent production of therapeutic products. As part of our Manufacturing Sciences team, you'll work at the intersection of research and production, supporting process optimization, technology transfer, and continuous improvement initiatives.
You'll collaborate with cross-functional teams to resolve technical challenges and ensure robust, scalable manufacturing processes that meet quality standards.
The primary responsibility is the execution of Manufacturing Sciences and Technology activities in support of technology transfer, late stage clinical, PPQ and commercial manufacturing of viral vectors.
The individual will serve as Subject Matter Expert in upstream processing. This position requires close interaction with MS&T colleagues, Project Management, Manufacturing, Quality Assurance, Quality Control, BioProcess Sciences, Engineering, Supply Chain and other departments.
This role will focus on aspects of implementing and profiling robust, scalable and efficient manufacturing processes to produce late-phase human clinical trial and commercial gene transfer vector products.
Essential Responsibilities:
Lead technology transfer for the upstream cGMP manufacturing viral vectors and other modalities.
Collaborate with other sites or clients to ensure success of process transfer and scale up.
Ensure effective information flow, risk assessment, timeline execution, issue resolution and documentation for cross-functional teams.
Includes authoring detailed process definition and facility fit assessment exercises.
MST process leads for Upstream processes, ensuring the materials, strategy and documentation are in place.
Collaborate with BPS/QC/QA to develop testing strategy for raw materials and process intermediates.
Author and maintain detailed process description/process control strategy documents throughout the lifecycle of a program
Author and maintain process risk assessment documents
Author PPQ protocols and reports. Oversee execution of PPQ and PPQ related activities
Support engineering teams on equipment selection, qualification, and start up activities.
Develop sampling plans with internal QC and clients to incorporate into cGMP batch documentation.
Monitor and trend process performance, including input and output parameters.
Provide product quality impact assessments and investigate root causes of major deviations for cGMP manufacturing, and implement CAPA for major deviations
Identifying opportunities to improve systems and practices
Work with counterparts in BioProcess Sciences, Manufacturing, Quality, Project Management teams etc. to facilitate technology transfer and project success.
Keys to Success:
Advanced Degree with no prior experience required, OR Bachelor's Degree plus 2 years of experience in GMP manufacturing, process development, or related technical role required.
Preferred Fields of Study: Chemistry, Biochemistry, Chemical Engineering, Biotechnology, Molecular Biology, or related scientific field.
Experience with adherent mammalian cells (preferably HEK).
Technical expertise in upstream biopharmaceutical manufacturing and/or process development.
Knowledge of Stirred Tank, single use Bioreactors, flat stock technology including Cellstacks, Hyperstacks and iCellis.
Expertise in late stage/commercial technology transfer, process validation of biopharmaceutical/gene transfer vector manufacturing preferred.
Working knowledge of GMP and regulatory requirements of biopharmaceutical manufacturing.
Knowledge of cell and gene therapy vector production is highly desirable.
Ability to work both independently and as part of a team.
Ability to function in a fast-paced dynamic team environment and balance prioritize multiple projects
Project management skills desirable
Laboratory skills and the ability to be hands-on.
Ability to speak effectively before groups of customers.
Excellent troubleshooting skills and ability to solve complex technical issues. Ability to compile, analyze and interpret data; Ability to write routine reports and correspondence.
Strong interpersonal and communication skills, verbal and written.
Ability to speak effectively before groups of customers.
Ability to communicate in a dynamic environment.
Benefits
We offer competitive remuneration, annual incentive plan bonus scheme, healthcare, and a range of employee benefits! Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.
Compensation and Benefits
The salary range estimated for this position based in Massachusetts is $66,000.00–$99,000.00.This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:
A choice of national medical and dental plans, and a national vision plan, including health incentive programs
Employee assistance and family support programs, including commuter benefits and tuition reimbursement
At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards
