Drug Product and Stability Chemist I - 1st Shift

Quality Seymour, Indiana


Description

DRUG PRODUCT & STABILITY CHEMIST I

Summary:

This position is primarily responsible for the laboratory testing of in-process, release and stability samples for commercial drug products.  Work on a team of 6 or more analysts.  No direct reports.  No purchase approval or budget responsibilities.

Responsibilities:

  • Perform accurate and timely analysis of in-process, release and stability samples for drug products according to current analytical procedures, SOPs, laboratory guidelines and safety requirements
  • Testing performed to include basic lab equipment and procedures, such as pH, Assay by HPLC, and Dissolution
  • Document all laboratory testing and maintain accurate and legible notebooks and records
  • Peer review of data, reports and notebooks

Education/Qualifications:

  • BS Degree in Chemistry or related field
  • AS Degree in Chemistry or related field and a minimum of 2 years of pharmaceutical product analysis experience in a cGMP-regulated lab environment accepted in lieu of 4-year science degree
  • BS Degree in non-science field and a minimum of 4 years of pharmaceutical product analysis experience in a cGMP-regulated lab environment
  • Knowledge of cGMP, USP/NF, and FDA guidelines and regulations
  • Experience in analytical methods and lab instrumentation (e.g. HPLC, GC, dissolution, wet chemistry)
  • Excellent oral and written communication skills
  • Strong organization and time management skills
  • Demonstrated ability to work as part of a cross-functional team
  • Working knowledge of Microsoft Word and Excel
  • Experience with software associated with a Laboratory Information Management System (LIMS) and a Chromatography Data System (CDS)
  • Work mainly performed in lab
  • Travel < 5%
  • Decisions require some judgment. Perform repetitive or routine duties working from detailed instructions and under standard procedures. Requires making minor decisions.
  • Individual contributor, not responsible for the work of others.
  • Primarily within department or immediate work unit: Requires contacts within the department or functional area on routine matters.  Occasionally contacts individuals outside the department or functional area.