Analytical Chemist

Lewes, DE

Position Summary

The primary objective of position is to work in our Quality Control Lab performing analytical method development, troubleshooting, and validation, as well as routine testing, as needed.  Previous experience planning and executing method validation studies is required.  Experience in instrumental analysis, such as UPLC/HPLC, GC, FTIR, UV, ICP, AA, Karl Fisher, particle size analysis, as well as in wet chemistry techniques is important. Experience in a pharmaceutical/food/chemical manufacturing environment preferred.  Experience in a GMP/FDA regulated facility is a strong plus along with basic computer skills. Veterans are strongly encouraged to apply.

 

Essential Duties and Responsibilities

  • Assists QC management in development of new analytical methods
  • Designs and conducts validation studies for a variety of analytical methodologies
  • Writes method validation protocols and reports
  • Writes new analytical test methods and revises current ones, as needed
  • Supports QC Supervisor in special projects
  • Participates in the transfer of methods for new products and processes
  • Performs testing of raw materials, finished product, and stability samples, as required
  • Provides guidance to other chemists and laboratory technicians on testing, as necessary
  • Assists in investigations and CAPA setting

 

Leadership Traits

  • Honesty, integrity, and the ability to work collaboratively, respectfully and safely
  • A strong contributor with the ability to effectively manage up, down, and across the organization
  • Drives accountability within the organization
  • Leads by example and actively engages appropriate personnel to make informed decisive decisions
  • Effective clear and concise communication
  • Ability to work and lead in a diverse, global organization

 

Supervisory Responsibilities

This position will have no direct reports.

 

Education and/or experience

  • Minimum 4 yr degree in chemistry or related science
  • Minimum 2 yrs method development/validation experience in the pharmaceutical industry
  • 3-5 yrs experience within a GMP/FDA regulated QC lab preferred
  • Sound judgment in interpreting regulatory, compendial, ICH, and SOP requirements
  • Ability to multi-task, schedule work, and manage priorities with minimal supervision
  • Excellent communication skills / team player
  • Strong writing and documentation skills 

 

Travel Requirements

The position will be located at the SPI Pharma Lewes Manufacturing Site.

Limited travel necessary

Apply now