At MannKind our employees are our number one asset, and we continue to be a tight-knit community where each of us has a critical role in our 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.
Position Summary:
MannKind Corporation is currently seeking a Scientist III, Data Reviewer to provide general support to maintain quality control systems within the company. This position 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 companys 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.
Principal 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. Professional interactions are primarily within the QC organization.
- Responsible for observing all Company, Health, Safety and Environmental guidelines.
Duties and responsibilities are not limited to the work listed above and may include other assignments as necessary.
As a member of the Quality organization at MannKind Corp. the incumbent is also expected to use quantitative reasoning; and to be professional, committed to excellence, customer focused, detail oriented, a communicator, and a team player.
Qualifications and Education Requirements
- BS Degree in a scientific discipline with 5+ years related experience or an equivalent combination of training and experience
- A working understanding of/experience in GMPs and regulatory guidance
- Ability to think analytically along with good communication, organizational, and interpersonal skills
- Must have experience in HPLC analysis and other required techniques
- Proficient in the use of a word-processing and spreadsheet program
- Understanding of GMPs and regulatory guidelines as they relate to the pharmaceutical products preferred
- Good analytical chemistry and quantitative and qualitative analytical skills
- At least 5+ years' experience in a laboratory setting, preferably in pharma
- 5+ years experience in quality control systems
- Access, Excel, Word and Power Point skills
