FSP Associate Research Scientist: Stability

Work Schedule

First Shift (Days)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards

Job Description

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.

Education and Experience 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.

* Familiarity with laboratory test methods desired.

Duties and 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.

Work Environment:

Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

* 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.

* May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.

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

Why Join Us?

When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You'll work in an environment where collaboration and development are part of the everyday experience-and where your…