Analytical Scientist I

Durham, United States

BioCryst Pharmaceuticals

Posted on: January 14, 2021

Closing: February 13, 2021

Salary: Undisclosed

Position Type: Full Time

Job Description

BioCryst Pharmaceuticals discovers novel, oral, small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. Oral, once-daily ORLADEYO™ (berotralstat) is approved in the United States for the prevention of HAE attacks in adults and pediatric patients 12 years and older, and under regulatory review for approval in Japan and the European Union. BioCryst has several ongoing development programs including, an oral Factor D inhibitor for the treatment of complement-mediated diseases, galidesivir, a potential treatment for COVID-19, Marburg virus disease and Yellow Fever, and BCX9250, an ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst’s first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, and Korea. Post-marketing commitments for RAPIVAB are ongoing. For more information, please visit the Company’s website at www.biocryst.com.

 

JOB SUMMARY:

Perform and oversee analytical testing of drug substance, drug products, and related materials according to written standard operating procedures (SOPs) and test methods.

 

ESSENTIAL DUTIES & RESPONSIBILITIES:

  • Preparation of mobile phases, standards, samples, and other laboratory solutions according to test methods.
  • 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.
  • Oversee the analytical progress during the manufacturing campaign of a drug substance and drug product at a CMO.
  • Maintains personal training record.
  • Assure that all aspects of method development, validation, troubleshooting and laboratory compliance procedures are in accordance 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.
  • All other duties as assigned.

 

EXPERIENCE & QUALIFICATIONS:

  • Bachelor/Master’s degree in a scientific discipline or equivalent experience, Chemistry major preferred with 0-3 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.
  • 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.

 

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.


Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)

BioCryst Pharmaceuticals

Posted on: January 14, 2021

Closing: February 13, 2021

Salary($): Undisclosed

Position Type: Full Time

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Career Focus: Chemistry, Scientist, Analyst

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