Drug Substance MSAT Scientist II

ThermoFisher Scientific; Plainville (MA); On-site; USD 66,000 - 99,000; Full time

Benefits offered by this job

Medical & dental plans

Vision plan

PTO and holidays

401(k) plan

ESPP

Job summary

Thermo Fisher Scientific in Massachusetts is seeking a Technology Transfer professional to perform manufacturing process development for injectable products and to drive successful scale-up and technology transfer projects.

You will support client calls, prepare documentation including work orders, protocols and reports, and operate with minimum supervision while upholding GMP standards and rigorous scientific methodology in a fast-paced pharmaceutical setting.

Qualifications

• 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.

Responsibilities

• Tech transfer and process development for injectable products.
• Support client calls and prepare documentation with minimum supervision.
• Write/revise work orders, FORMs, reports, memos, and protocols.
• Lead projects with moderate supervision and manage change controls.

Skills

Scientific methodology

Tech transfer

Process development

Statistical analysis

Education

Bachelor’s of Science in Chemistry/related field

Job description

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.

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 drug substance formulation, and Downstream processes.
• 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 experience in tech transfer or process validation
• 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.

Excellent knowledge of scientific methodology and development as related to the pharmaceutical industry.

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 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

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.