Apply on Employer Site

Thermo Fisher Scientific · 2 weeks ago

Senior Scientist - QC Stability Data Review

Boston, MA

Full-time

Onsite

Mid, Senior Level

$90K/yr - $110K/yr

4+ years exp

Thermo Fisher Scientific is a leading global contract research organization dedicated to making the world healthier, cleaner, and safer. The Senior Scientist - QC Stability Data Review will perform technical and quality reviews of stability data and related documents, ensuring compliance with Good Manufacturing Practices while contributing to the development of life-changing therapies.

BioinformaticsBiotechnologyCloud Data ServicesConsultingHealth CareLife ScienceManagement Information SystemsOffice SuppliesPrecision Medicine

No H1B

Responsibilities

Perform technical and quality reviews of internal and external documents, including raw data, stability protocols/reports, CoAs/stability data reports, risk assessments, sampling plans, shelf-life reports and etc

Enter and trend stability data in SLIM system and generate stability timepoint summary reports

Establish/extend DS and DP shelf lives and generate shelf-life reports based on stability data

Plan, manage and communicate stability pulls and ensure stability testing occurs within specified testing windows

Qualification

Stability studiesStability protocolsSLIM systemRisk assessmentsMultitaskingAttention to detail

Required

Bachelor's degree in lab sciences such as Chemistry, Biochemistry, Material Science, Immunology, Biology, Molecular Biology or similar

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 4+ years')

OR Masters degree and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years')

OR PhD

Proven Experience with stability studies, stability protocols/reports, CoAs/stability data reports, risk assessments, sampling plans, shelf-life reports, including raw data and external documents

Stability data in SLIM system and generate stability timepoint summary reports

DS and DP shelf lives and generate shelf-life reports based on stability data

Plan, manage and communicate stability pulls and ensure stability testing occurs within specified testing windows

Attention to detail and ability to multitask, review tons of data

Must be legally authorized to work in the United States without sponsorship

Must be able to pass a comprehensive background check, which includes a drug screening

Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner

Able to work upright and stationary and/or standing for typical working hours

Able to lift and move objects up to 25 pounds

Able to work in non-traditional work environments

Able to use and learn standard office equipment and technology with proficiency

Able to perform successfully under pressure while prioritizing and handling multiple projects or activities

Benefits

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