Scientist III, Quality Control (2nd Shift, Tues-Sat 12:30pm to 9:00pm)

MannKind Corporation•Danbury, CT

35d

About The Position

At MannKind our employees are our number one asset, and we continue becoming a tight-knit community where each of us plays a critical role in our collective success. Committed to diversity, at MannKind we depend on a rich blend of ideas, backgrounds, and working styles in our quest to change the world for the better. Job Summary: Provides general support to maintain quality control systems within the company. Ensures that performance and products conform to established company and regulatory standards. Analyzes finished formulations, raw materials, in process materials, or stability samples by HPLC/GC, in support of the company's quality program. Interprets and evaluates the analyses in terms of accuracy and precision and recommends corrective action where necessary. Performs qualitative tests or quantitative assays on samples using techniques that vary from use of standard analytical equipment to highly modern and automated instrumentation.

Requirements

BS Degree in a scientific discipline with 5+ years related experience or an equivalent combination of training and experience
At least 5+ years' experience in a laboratory setting, preferably in pharma
5+ years' experience in quality control systems
EMPOWER experience is required
Good written communication skills
Understanding of GMPs and regulatory guidelines as they relate to the pharmaceutical products preferred
Good interpersonal skills
Access, Excel, Word and Power Point skills

Responsibilities

Conduct routine and non-routine HPLC/GC analysis of raw materials, in process, and finished formulations according to standard operating procedures.
Perform chemical analyses of product to ensure stability.
Compile data for documentation of test procedures that may include microbiological and/or chemical assays, stability program testing and formulation studies.
Calibrate and maintain lab equipment.
Participate in the preparation of investigations, summaries and reports.
May assist in developing testing methods.
Review data obtained for compliance to specifications and report abnormalities.
Revise and update standard operating procedures as needed.
May perform special projects on analytical and instrument problem solving.
Applies knowledge of good manufacturing practices, good laboratory practices and good record keeping practices on a daily basis.
Follows written test methods and protocols.
Process data, report data and prepare tables and graphs for the completed testing. Identify problems, e.g. out of trend data.
Responsible for observing all Company, Health, Safety and Environmental guidelines.