Senior R&D Scientist

Medisca•Irving, TX

10h•Onsite

About The Position

A Medisca Partner, CED Analytical Labs is an analytics testing laboratory that delivers customized solutions with an unwavering commitment to quality and innovation that their customers can always count on. Offering worry-free and agile testing services at the highest standards of quality, CED Analytics supports partners in the pharmaceutical compounding, life-science, and healthcare industries. Committed to Partners in Wellness, CED Analytics offers an unfailing devotion to improving lives across a multitude of needs and multitude of people. The Senior R&D Scientist serves as an active member of the pharmaceutical laboratory and provides scientific support to ongoing method/assay development and validation. This includes generation of pre-protocol documentation (development/validation plans), conducting experiments, reviewing results, and providing reports on results and conclusions. As a senior member of the R&D team, you lead by example and provide support and guidance to other member of the team. The position is on site in Irving, Texas. The opportunity Applies the principles, theory, and techniques of Good Laboratory Practices (GLP) to produce and report appropriate pharmaceutical laboratory results. Monitors test methods and analyses to ensure that acceptable levels of analytical performances are maintained. Provides subject matter expertise to the laboratory, using a systematic approach to problem-solving. Develops new tests/assays and/or improvements to existing tests, with guidance from the Lead R&D Chemist. Writes formal validation plans, timelines, and reports and provides oversight in the creation and execution of validation plans and reports of all R&D projects. Participates in the training of laboratory staff in principles of methods and applications within the services according to CED Analytical Laboratory quality system procedures. Aids in the investigation, installation, evaluation, and purchase of: laboratory equipment instrumentation, computer software/hardware, and other specialty items. Participates in and records quality investigations and corrective actions, where appropriate. Reviews literature and competitive information for R&D planning and analysis of results. Collaborates with various groups for study level publication planning including manuscript writing and submissions. Collaborates to achieve publications for pharmaceutical study data through coordination with investigator authors and project management of reviews and revisions for abstracts and manuscripts. Generates documents to support regulatory submissions and/or responds to questions from regulatory authorities about existing submissions.

Requirements

MS in chemistry or a science related field, with knowledge of common laboratory techniques.
Eight (8) years of laboratory experience performing analytical testing.
HPLC expertise, method development and/or method validation experience required.
Working knowledge of cGMP/GLP, ICH, USP/NF, FDA regulations.
Knowledge of Microsoft Office suite (Word, Outlook, Teams and Excel) required.
Excellent communication skills: English (oral & written) required.
Strong work ethic and reliable.
Excellent time management and organizational skills.
Able to work under pressure and successfully function in a fast-paced environment.

Responsibilities

Method Validation Maintain an optimized schedule of method development activities.
Perform method/sample validation including: Method development. Generating protocol specified data. Analysis of data according to validation parameters. Statistical analysis of data; stability study trending. Validation report writing.
Sample Testing Run lab experiments and record data in laboratory notebooks with accuracy and completeness.
Calculate results as required in compendial methods and procedures.
Responsible for meeting due dates for the following testing: Perform instrumentation testing for finished product samples. HPLC assay, dissolution, etc. Perform wet bench testing for finished product samples. pH, viscosity, water determination, etc.
Inventory Login & Upkeep Maintain laboratory inventory of chemicals and supplies.
Check stock levels and order commonly used chemicals as needed.
Remove and update inventory for expired chemicals.
Periodic inventory of chemicals and supplies on hand.
Keeps and maintains work area clean, neat and organized during and after processing time.
Ensure all instruments used are well maintained and the workspace is kept neat.
Compliance to FDA regulations and CED SOPs.
Perform other duties as assigned.