Element Materials Technology

LCMS Chemist, Pharmaceutical Laboratory

Job Locations US-CA-Santa Fe Springs
ID
2020-5218

Overview

Element has an opportunity for an experienced LCMS chemist to perform routine and non-routine testing on various matrices including pharmaceutical products, raw materials, and other. Experience with method development and validation required. Instrument maintenance and troubleshooting experience a plus. 

Responsibilities

  • Serves as an individual contributor responsible for contributing towards Element’s Extractables and Leachables (E&L) program, R&D and GMP-regulated method development, validation and routine testing
  • Independently conduct analyses of chemical samples for various analytes especially LC-MS and LC-MS/MS (QTOF, Triple Quadrupole platforms), interpretation and develops conclusions of analytical data
  • Establish all analytical experiments for multiple projects simultaneously
  • Conducts method development and validations according to clients’ needs in a regulated environment
  • Perform method validations according to USP and ICH requirements
  • Observe and recognize deviations in results that could lead to inaccuracies, make remedies to assure reliable and accurate results
  • Operate, calibrate and maintain analytical instruments; recognize and investigate malfunctioning equipment and take action to troubleshoot, repair or arrange for service
  • Prepares and reviews SOPs, and other documentation
  • Generates technical protocols and reports, including technical review of reports for scientific accuracy and completeness
  • Ensure that study protocols and reports are amended in a timely fashion to accurately reflect any changes
  • Review, interpret, analyze, evaluate, and discuss study results with internal and external clients
  • Takes accountability and demonstrates responsibility regarding scientific study conduct
  • Support GMP operations
  • Other duties as assigned

Skills / Qualifications

  • Master’s degree or higher, preferably in Chemistry, with ideally 2-3 years of previous experience that provides the knowledge, skills and abilities to perform the job
  • An equivalent combination of education, training and experience may be accepted as a satisfactory substitute
  • Expertise with analytical instrumentation, especially with LCMS, LC-MS/MS, HPLC, GC-MS and sample preparation
  • Knowledge of analytical work in regulated environments
  • Understanding of ICH guidelines, USP requirements and FDA guidance
  • Analytical method development and/or validation experience
  • Proven good problem solving and troubleshooting abilities
  • Excellent scientific data / results interpretation abilities
  • Proven ability in technical writing skills, and excellent communication and interpersonal skills
  • Ability to work independently as well as in a collaborative team environment
  • Excellent attention to detail
  • Ability to prioritize and manage time
  • Ability to positively resolve conflict
  • Experience in an R&D and/or Extractables and Leachables is preferred
  • Experience in a contract research organization (CRO) is a plus

Company Overview

We are Element, one of the fastest growing testing, inspection, certification and calibration business in the world.

 

We deliver critical services in Materials Testing, Product Qualification Testing, Certification, Device Calibration and Advisory Services to the Aerospace, Oil and Gas, Transportation, Industrials, Fire and Building product, Infrastructure and other leading sectors, where failure in service is simply not an option.

 

Everything we do helps our customers to build better products; get their products to market on time; save them time and money; and minimize the risk associated with product development and production.

 

Our mission is simple: to be the best testing partner in the world and together we strive towards a common vision of becoming the world’s most trusted testing partner.

 

We have four values that we strive to live by every single day.

  • Safety - We keep our colleagues and visitors safe
  • Integrity - We act honestly and fairly to do the right thing
  • Excellence - We set new standards of excellence in everything we do
  • Partnership - We work together for the benefit of our customers

When combined with our mission and vision, the ethos this creates, enables Element to deliver one thing. CERTAINTY.  We exist to help make certain that the materials and products we test, inspect, certify and calibrate for our customers are safe, quality, compliant and fit for purpose.

Diversity Statement

At Element, we always take pride in putting our people first. We are an equal opportunity employer that recognizes diversity and inclusion as fundamental to our Vision of becoming “the world’s most trusted testing partner”.

 

All suitably qualified candidates will receive consideration for employment on the basis of objective work related criteria and without regard for the following: race, colour, age, religion, gender, national origin, disability, and/or protected veteran status, or other characteristics in accordance with the applicable governing laws.

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