Quality Control Director
Oversee day to day operations of the quality control, document management, raw materials and stability groups. Works closely with managers to ensure testing operations are performed, including capacity management, metrics and execution of testing. Maintains rigorous quality mindset and advocates strict adherence to compliance practices within the testing labs and facility. Possess scientific skills in the specific science area and a strong working knowledge of the technical, usp compendial testing, and current good manufacturing practice (cgmp) compliance requirements for in-process, raw materials and product quality testing. Remains current regarding product quality testing needs for biosimilars and works with the technical teams to develop / modify assays to meet requirements. Ensures that appropriate records are maintained according to and in compliance with fda guidelines for biosimilars, usp, glp, cgmp, code of federal regulations (cfr) and/or points to consider (ptc) guidelines, ich guidelines, and sops. Works closely with the analytical research and development team to receive and validation of new assays and technologies, as well as existing assays. responsibilities:
ensures quality control testing is scheduled and performed develops and manages to operational and performance metrics supervises, plans and reviews operations for assigned staff, including responsibility for training, managing and evaluating as well as coordinating, scheduling and assigning work and maintaining standards recommends hire / transfer / promotion / discharge and salary changes and acts on employee problems conducts employee performance appraisals in a timely and objective manner may act as study director for assigned assays and assumes all associated responsibilities interacts with other functional groups to discuss project planning and testing issues works with the analytical research and development team to provide strong in-house guidance on science and technology interacts with internal staff to identify assays requiring further improvement or development responsible for appropriately conducting assays in accordance with cgmps assures that laboratory personnel are following all company sops and safety rules prepares and revises technical documents (laboratory protocols, change controls, oos investigations, capas, sops, etc.) assures that test batch records and deviations, oos results, qa audits and other paperwork are completed according to cgmps and company sops
ph.D. In biochemistry/analytical chemistry with 10 years or bs or ms with 15 years quality control industry experience must have 8 or more years of experience with proteins and antibodies knowledge of cgmp and biosimilars guidelines is desirable ability to make decisions based on a wide knowledge of factors where application of advanced or technical concepts is predominantly required ability to evaluate technical data and write technical documents ability to use judgment as dictated by complexity of situation ability to work under limited supervision and to handle problems of a difficult nature ability to accomplish the described duties through the use of appropriate laboratory equipment (i.E. Biohazard hood, centrifuge, incubator, and autoclave) and computer equipment and software. (i.E. Microsoft word, outlook) +40 Other Responses
I am an aspiring novelist and i am currently working on a novel where my two main characters are a biochemistry professor and his student. Before i can fully develop my plot, i need to gain an understanding of what a 4th year university level biochemistry class is like.
A very small portion of my novel's setting takes place within the university, but i am still eager to 'get inside their heads' and fully understand the day-to-day lives of these two characters.
Any information provided will be greatly appreciated.+8 Other Responses
I am looking for an expert witness to testify regarding a variety of biochemical assays and specifically regarding the test results that these assays produce, how much effort is required to review the results of these assays, and the manner in which assay test results are reviewed and statistical analysis performed. The expert must have at least a masters or phd in biochemistry/pharmacology/cell biology or related field and expertise is drug development is preferred, as is expertise in cell-based assays to measure transcription factor inhibition. Biochemistry and pharmacology exe+16 Other Responses