Perform and oversee analytical testing of drug substances, drug products, and related materials according to written standard operating procedures (SOPs) and test methods.
ESSENTIAL DUTIES & RESPONSIBILITIES:
• Assure that all aspects of method development, validation, troubleshooting and laboratory compliance procedures are in accordance with regulatory guidelines.
• Operation, calibration, and maintenance of instruments and equipment according to SOPs.
• Reviews and may evaluate other chemists’ data and results.
• Develops and validates analytical methods; coordinated methods and technical transfers.
• Contribute towards the submission and approval of drug application dossiers, including an NDA Tracks down impurities and identifies them by spectroscopy techniques.
• Calculation, evaluation, interpretation, and documentation of data and results; reports abnormalities internally and at the CMO.
• Oversee the analytical progress during the manufacturing campaign of a drug substance and drug product at a CMO.
• Trend stability data and shelf-life experience.
• Performs other duties as needed to enable efficient operation of the laboratory; may include laboratory inventory and ordering, submission of samples to external testing facilities, and laboratory housekeeping.
• Writes and reviews SOPs and test methods.
• Assists in projects with contract manufacturing organizations.
• Preparation of mobile phases, standards, samples, and other laboratory solutions according to test methods.
• Maintains personal training record.
• All other duties as assigned.
EXPERIENCE & QUALIFICATIONS:
• Bachelor/Master’s/PhD degree in a scientific discipline or equivalent experience, Chemistry major preferred with 3-10 years of laboratory experience, and cGMP/GLP Pharmaceutical Industry experience.
• Excellent knowledge of and ability to perform analytical standard operating procedures and test methods of varying complexities.
• Able to work with minimal supervision.
• Details oriented with meticulous oversight.
• Able to meet deadlines, accomplish work in order of priority and adjust to new situations.
• Able to manage a heavy workload with multiple priorities.
• Able to evaluate, interpret and communicate analytical data.
• HPLC Method Development experience required.
• Excellent interpersonal skills and ability to work effectively in a team environment.
• Excellent communication skills (written and verbal).
• Excellent knowledge of standard analytical laboratory equipment, instrumentation, and associated software.
• Able to work in an organized manner, with attention to detail, and excellent documentation practices.
• Able to troubleshoot and problem-solve using analytical instrumentation, and scientific judgment.
• Participates in special teams and projects by contributing analytical expertise.
The statements in this position description are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. The manager may assign additional responsibilities and assignments from time to time.
BioCryst is an equal opportunity employer and is committed to providing equal employment opportunities without regard to age, race, religion, sex, sexual orientation, gender identity, national origin, Veterans status, disability and/or other protected class characteristics. Additionally, BioCryst is committed to achieving its business objectives in compliance with all federal, state and local law.