FSP Associate Research Scientist: Stability

Thermo Fisher Scientific • New Brunswick, NJ

1d • Onsite

About The Position

Join Us as an Associate Research Scientist – Make an Impact at the Forefront of Innovation We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years. As an Associate Research Scientist, you will perform complex laboratory analysis of pharmaceutical products and proficiently use analytical instrumentation, calculate and analyze data and record data in adherence with PPD SOP's and the industry. You will routinely act as the project leader on multiple projects, interact with clients, review and evaluate data, write reports and protocols. You will be responsible for the scientific conduct of the project and communication of regulatory issues with senior level team members. What You'll Do: This position is in the Stability group in the Analytical Strategy & Operations (ASO) department and is located in New Brunswick, New Jersey. This position will primarily support stability sample management in the Stability Operations group, including labeling, organizing samples, and weighing drug substance powders in a hood. In addition, the associate will apply knowledge of stability guidelines to author stability protocols, reports and regulatory submission stability sections in support of small and large molecule products. In addition, Refer to the Other Requirements section. Note, there is no analytical work required for this position.

Requirements

• The candidate must have a B.S. or equivalent with a degree in Analytical Chemistry, Chemistry, Biochemistry or equivalent; 6-8 years of experience in the pharmaceutical industry in a GMP environment is preferred.
• The candidate must demonstrate good communication skills, particularly in documentation of data and writing reports and methods. Skill in communicating/escalating critical issues to appropriate team leaders and functional area management is necessary.
• The candidate must be able to deliver when working under assigned timelines and with minimal supervision.
• Understanding of cGMP and EHS requirements is essential. Ability to comply with all applicable SOPs, internal requirements and external regulations is a must.
• Expertise in MS Office applications, in particular MS Word and Excel, is required.
• Familiarity with electronic documentation systems (e.g. QUMAS, Infinity, LIMS) for routing protocols/reports, for review and approval is a plus.

Nice To Haves

• Familiarity with laboratory test methods desired.

Responsibilities

• Must be able to work with samples and weighing of drug substance powders.
• Must be able to occasionally lift up to 50 lbs
• The candidate will be responsible for organizing and labeling stability samples and delivering samples to New Brunswick labs or packing and shipping samples to external labs.
• The candidate will interact with stability scientists, written protocols, and laboratory information management system (LIMS). Must have good organizational and time management skills and attention to detail is essential.
• Creates stability data tables and/or checks data transcribed to data tables from other reports.
• Authors stability protocols in accordance with global stability guidelines to support clinical use and registration of small and large-molecule drug substances and products.
• Analyzes and trends stability data. Can identify issues, summarizes and presents results from stability studies and authors technical memos and reports.
• Authors the stability section in investigational global filings.
• Manages protocol and stability data reports in LIMS.
• Liase with CMC team when needed to support stability deliverables.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level