Manager, Analytical Development & QC

Location
Birmingham, Alabama
Salary
Very competitive
Posted
Jul 21, 2021
Closes
Sep 19, 2021
Field of specialization
Analytical
Work Function
Laboratory
Job Type
Full time

<p><strong>JOB SUMMARY:</strong></p> <p>The Manager, Analytical Development &amp; Quality Control will oversee the day to day activities in our Analytical Development &amp; QC lab including analytical testing of drug substance, drug products, and related materials internally according to written standard operating procedures (SOPs) and test methods, and handle other tasks as needed. The selected candidate will oversee and support the upgrade of our laboratory.</p> <p><br /> <strong>ESSENTIAL DUTIES &amp; RESPONSIBILITIES:</strong></p> <p>• Lead the Analytical Development/QC day-to-day operation.<br /> • Lead and train a group of highly skilled scientists.<br /> • Assure that all aspects of method development, validation, troubleshooting and laboratory compliance procedures are in accordance with regulatory guidelines.<br /> • Maintains personal training record and assure the QC team training record is up to date.<br /> • Reviews and may evaluate other chemists’ data and results.<br /> • Operation, calibration, and maintenance of instruments and equipment according to SOPs.<br /> • Develops and validates analytical methods; coordinated methods and technical transfers.<br /> • Contribute towards the submission and approval of drug application dossiers, including an NDA<br /> • Tracks down impurities and identifies them by spectroscopy techniques.<br /> • Calculation, evaluation, interpretation, and documentation of data and results; reports abnormalities internally and at the CMO.<br /> • Oversee the analytical progress during the manufacturing campaign of a drug substance and drug product at a CMO.<br /> • Trend stability data and shelf-life experience.<br /> • 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.<br /> • Writes and reviews SOPs and test methods.<br /> • Assists in projects with contract manufacturing organizations.<br /> • Preparation of mobile phases, standards, samples, and other laboratory solutions according to test methods.<br /> • All other duties as assigned.</p> <p><strong>EXPERIENCE &amp; QUALIFICATIONS:</strong></p> <p>• A minimum of a bachelor’s degree and 10 years of experience required.<br /> • Graduate level degree (M.S./Ph.D.) in Chemistry preferred.<br /> • cGMP/GLP Pharmaceutical Industry experience required.<br /> • Experience in managing scientists.<br /> • HPLC Method Development experience required.<br /> • Excellent interpersonal skills and ability to work effectively in team environment.<br /> • Excellent communication skills (written and verbal).<br /> • Excellent knowledge of and ability to perform analytical standard operating procedures and test methods of varying complexities.<br /> • Excellent knowledge of standard analytical laboratory equipment, instrumentation, and associated software.<br /> • Able to work in an organized manner, with attention to detail, and excellent documentation practices.<br /> • Able to troubleshoot and problem-solve using analytical instrumentation, and scientific judgment.<br /> • Participates on special teams and projects by contributing analytical expertise.<br /> • Able to work with minimal supervision, detail-oriented with meticulous oversight.<br /> • Able to meet deadlines, accomplish work in order of priority, and adjust to new situations.<br /> • Able to manage a heavy workload with multiple priorities.<br /> • Able to evaluate, interpret, and communicate analytical data to team members.</p> <p><em>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.</em></p> <p><em>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.</em></p> <p>&nbsp;</p> <p>&nbsp; Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities</p> <p>&nbsp;</p> <p>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).</p>

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