Manager of Analytical Development and Quality Control
Analytical Development / Quality Control
Oversee analytical testing of drug substance, drug products, and related materials internally and at CMO according to written standard operating procedures (SOPs) and test methods and other tasks as needed.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Operation, calibration, and maintenance of instruments and equipment according to SOPs.
- 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 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.
- Maintains personal training record.
- Assure that all aspects of method development, validation, troubleshooting and laboratory compliance procedures are in compliance with 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
- Oversee the analytical progress during the manufacturing campaign of a drug substance and drug product at a CMO
- Collaborates with the pharmaceutical development team to review master batch records and analytical raw data
- Excellent knowledge of and ability to perform analytical standard operating procedures and test methods of varying complexities.
- Excellent knowledge of appropriate regulations (cGMP/GLP).
- 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.
- Bachelor’s degree in a scientific discipline, Chemistry major preferred.
- 7 – 15 years of laboratory experience, cGMP/GLP Pharmaceutical Industry experience preferred.
- Excellent interpersonal skills and ability to work effectively in team environment.
- Excellent communication skills (written and verbal).
Top 3 to 5 Technical Skills:
- 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 trouble-shoot and problem-solve using scientific judgment.
- Able to contribute analytical expertise to special teams and projects.
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 laws.
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.