Scientist II or III - Bioanalytical Sample Management - FSP

Parexel

13d•Onsite

About The Position

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. We are looking to fill a Bioanalytical Sample Management position working as a full-time employee of Parexel FSP on long-term assignment onsite at one of our clients located in West Point, PA. This position offers full benefits, sick time, 401K, paid holidays, and paid time off. This position does not offer any sponsorship. About Parexel Parexel FSP includes the CMC Operations group. We provide pharmaceutical and biopharmaceutical companies with qualified and talented technical professionals to support the development and delivery of new therapies. For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is trusted by life sciences companies to meet their long-term staffing needs for scientists and engineers and related professionals in discovery and development of novel therapies, keeping patients at the center of everything we do, and where an inclusive community helps you be your best, transforming any career into a life-changing achievement. Come join us!

Requirements

Scientist 2: Bachelors degree with 1-2 yrs of experience in a biological science discipline
Scientist 3: Bachelors degree with 3-5 yrs of experience or Master’s degree with 1+ yrs of experience in a biological science discipline
Strong knowledge in GxP and compliance guidelines, preferably in a bioanalytical laboratory environment
Experience managing sample chain of custody within a GLP/GMP lab
Utilize electronic laboratory notebooks for laboratory documentation
Operate within the confines of departmental SOPs and regulatory guidance’s
Capable of working independently under moderate supervision
Possesses good verbal and written communication skills and comfortable interacting with a variety of on-site and off-site collaborators

Nice To Haves

Computer literacy knowledge (e.g. MS Office) and experience using a laboratory LIMS system (e.g. Watson LIMS, Labware LIMS, Benchling, etc)
May Author SOPs associated with sample or reagent management processes.

Responsibilities

Maintain and manage inventory of GLP and Clinical bioanalytical samples and critical reagents
Utilize one or more Laboratory Information Management Systems (LIMS) to track sample chain of custody from receipt through disposal/shipping
Coordinate domestic and international sample or reagent shipments off-site.
Perform aliquoting of clinical samples either through manual pipetting or lab automation.
Participate in CTU maintenance and alarm handling
Retrieve and provide materials to bioanalytical staff on site
Communicate with clinical sites, central lab, or on-site collection areas for receipt of materials and discrepancy resolution.