Scientist III, Quality Control Specialist

4 weeks ago

Danbury, Connecticut, United States MannKind Full time

At MannKind, we value our employees as our most critical asset. Our tight-knit community relies on a diverse blend of ideas, backgrounds, and working styles to drive our mission to change the world for the better.

Job Summary

As a Quality Control Specialist, you will play a vital role in maintaining our quality control systems, ensuring that our products and performance meet established company and regulatory standards. You will analyze chemical, biological, or microbiological products, raw materials, in-process materials, or stability samples to support our quality program.

Key Responsibilities
  • Conduct routine and non-routine analysis of raw materials, in-process, and finished formulations according to standard operating procedures.
  • Develop and implement methods and procedures for new assignments, working independently to determine the best approach.
  • Perform experiments in accordance with written procedures and/or under the direction of a supervisor.
  • Manage equipment calibrations/qualifications with minimal supervision.
  • Assist in the development and training of peers and less skilled employees in the execution of analyses and/or the use of specialized equipment.
  • Compile data for documentation of test procedures, including microbiological and chemical assays, stability program testing, and formulation studies.
  • Calibrate and maintain lab equipment.
  • Participate in the preparation of investigations, summaries, and reports.
  • May lead in developing test methods.
  • Review data obtained for compliance to specifications, report abnormalities, and may lead root cause investigations.
  • Write, revise, and update standard operating procedures as needed.
  • May perform special projects on analytical and instrument problem-solving.
  • Apply knowledge of good manufacturing practices, good laboratory practices, and good record-keeping practices on a daily basis.
  • Follow written test methods and protocols.
  • Summarize and/or process data and prepare tables and graphs for submission to regulatory agencies.
  • Ability to recognize issues and develop strategy to proceed forward with supervisor's input.
  • May determine methods and procedures on new assignments and may provide guidance to other lower-level personnel.
  • Represent the group at appropriate meetings.
  • Responsible for observing all Company, Health, Safety, and Environmental guidelines.

As a member of our development organization, you will be expected to use quantitative reasoning and demonstrate professionalism, commitment to excellence, customer focus, detail orientation, communication skills, and teamwork.

Qualifications
  • BS Degree in Chemistry with 4-6 years or MS Degree with 2-4 years or PhD Degree with 0-2 years related experience.
  • A working understanding of GMPs and regulatory guidance.
  • Ability to think analytically along with good communication, organizational, and interpersonal skills.
  • Must have knowledge of Empower.
  • Must have experience in HPLC analysis and other required analytical techniques.
  • Proficient in the use of a word-processing and spreadsheet program.
  • Understanding of GMPs and regulatory guidelines as they relate to pharmaceutical products preferred.
  • Good analytical chemistry and quantitative and qualitative analytical skills.
  • An understanding of basic statistical concepts and working knowledge of one or more statistical and other technical software packages.
  • Excel, Word, and PowerPoint skills.

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