Scientist Analytical Development and QC

Location
Birmingham AL
Position Id
1037
Date Posted
4/25/2019

GeneCoda has been engaged to identify and evaluate candidates, for a Scientist Analytical Development and QC to be located in Birmingham, AL.

About Our Client:

Our client is a growing pharmaceutical company with a strong technological platform that develops compounds focusing on orphan and rare diseases. Our client has numerous collaborations and in-license relationships with premier research institutions, the US government, and global partners.

Narrative:

Our client develops internal methods, does pre-qualifications and transfers methods to contract (CMO) labs for clinical and commercial manufacturing. As part of the discovery team, the Scientist Analytical Development and QC will develop routine tests, qualify reference standards, support stability programs, and facilitate investigations. Our client is seeking a nimble analytical chemist who is interested in developing tests at the bench and in a semi-virtual drug development environment.

The Scientist Analytical Development and QC performs and oversees analytical testing of drug substance, drug products, and related materials according to standard operating procedures (SOPs) and test methods.

Key Responsibilities:

  • Preparation of standards, samples, and other laboratory solutions according to test methods.
  • Operation, calibration, and maintenance of instruments and equipment.
  • Calculation, evaluation, interpretation, and documentation of data and results; reports abnormalities internally and at the CMO.
  • Trend stability data and shelf-life experience.
  • Performs other duties to enable efficient operation of the laboratory; may include lab inventory and ordering, submission of samples to external testing facilities, and laboratory housekeeping.
  • Writes and reviews SOP’s and test methods.
  • Assists in projects with contract manufacturing organizations.
  • Oversee the analytical progress during the manufacturing campaign of a drug substance and drug product at a CMO.
  • Assures that all aspects of method development, validation, troubleshooting and laboratory compliance procedures are following regulatory guidelines.
  • Contribute towards the submission and approval of drug application dossiers, including an NDA.
  • Reviews and may evaluate other chemists’ data and results.
  • Develops and validates analytical methods; coordinated methods and technical transfers
  • Tracks down impurities and identifies them by spectroscopy techniques

Education:

BS and/or MS in chemistry or related field.

Experience:

  • Ability to perform analytical SOP’s and test methods of varying complexities generally evidenced by 2-5 years of analytical lab experience.
  • HPLC and Mass Spectrometry (MS) experience is required.
  • GMP / GLP pharmaceutical/biotechnology industry experience is preferred.
  • Data review experience.

Core Competencies:

  • Strong team player, with proven ability to contribute to a multi-disciplinary team environment.
  • Strong time management and organizational skills.
  • Detail oriented.
  • Excellent communication and collaboration skills.
  • Self-starter, results-oriented, and able to multi-task.

GeneCoda refers qualified applicants for all jobs without regard to race, color, religion, creed, age, sex, disability, marital status, national origin, pregnancy, family medical history or genetic information, sexual orientation or preference, Vietnam Era Veteran status or other protected military status or any other status protected by federal, state or local law.

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