Drug Product MSAT Scientist II

Job Title

As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale.

Work Schedule:

Standard (Mon-Fri)

Environmental Conditions:

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description:

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.

Discover Impactful Work!

· 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.

A Day in the Life.

· 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.

Education:

Bachelor's of Science in Chemistry, Biochemistry, Biology, Pharmaceutical, Engineering or related physical science.

Experience:

Bachelors and 2+ years of related experience, or, related Master's degree.

Experience in a CMO or Pharmaceutical product development field

Knowledge, Skills, Abilities:

· Excellent knowledge of scientific methodology and development as related to the pharmaceutical industry. Prior engineering experience in Fill line is preferred plus

· 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.

Benefits:
We offer competitive remuneration, annual incentive plan bonus, 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!

Other:
Relocation assistance is not provided.

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.

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…