Drug Product MSAT Scientist II

Thermo Fisher Scientific•Plainville, MA

2d•Onsite

About The Position

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. In this role, you will complete Technology Transfer activities by performing manufacturing process development for Injectables products to commercial lines. Using experimental design, establish formulation processes, product pathway and select components for successful scaleup. Support client calls, prepare documentation (including but not limited to work orders, protocols, summaries, with minimum supervision), and provides scientific justification and update status of project work as needed.

Requirements

Bachelor’s of Science in Chemistry, Biochemistry, Biology, Pharmaceutical, Engineering or related physical science.
Bachelors and 2+ years of related experience, or, related Master’s degree.
Experience in a CMO or Pharmaceutical product development field
Excellent knowledge of scientific methodology and development as related to the pharmaceutical industry.
Detailed knowledge of Good Manufacturing Practices.
Effective written, interpersonal, and presentation skills, including running technical discussions with internal and external clients.
Ability to work on multiple projects simultaneously.
Ability to acquire knowledge and skills in pharmaceutical processes, equipment, instrumentation, and procedures.
Ability to keep current with scientific literature and industry trends relating to process technologies.
Ability to run technical solutions.
Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand and walk; ability to lift and/or carry light objects of up to 25 lbs. for brief periods.
Must be legally authorized to work in the United States now and in the future, without sponsorship.
Must be able to pass a comprehensive background check, which includes a drug screening.

Nice To Haves

Prior engineering experience in Fill line is preferred plus

Responsibilities

Technically supports day-to-day operations in the Formulation, Filling, and/or Freeze Drying areas of the Steriles plant.
Works on technical/scientific process/product/project activities to implement strategies and technical solutions.
Assists in the creation of processes, single use systems, and equipment designs for clinical, scale up, and/or registration batches, including technology transfer of projects from clients.
Makes decisions that involve direct application of technical knowledge.
Complete studies, tech transfer, commercial scale-up and support process validation.
Represent the organization on internal technical discussions.
Actively participate in problem solving and project results for formulations, equipment and processes.
Write/revise work orders for existing processes, FORMs, reports, memos, and protocols.
Lead projects with a moderate level of supervision, implement change control actions, review and plans technical aspects of the project to meet timeline and project goals.
Support manufacturing operations, change controls, investigations as subject matter expert (SME).
Collects data for statistical analysis. Can support interpretation and summary of data.

Benefits

competitive remuneration
annual incentive plan bonus
healthcare
a range of employee benefits
employment with an innovative, forward-thinking organization
outstanding career and development prospects
exciting company culture that stands for integrity, intensity, involvement, and innovation!
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
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