Postdoctoral Associate in Pharmacokinetic Core Laboratory
Newly established PK Lab is seeking a PhD level scientist (postdoctoral associate) to join our team at BNI!
About BNI: The Barrow Neurological Institute (BNI) (Phoenix, AZ), has been ranked in the top 10 best hospitals for neurology and neurosurgery since the US News and World Reports began reporting such data. The BNI leads the largest pharmacokinetics (PK) and pharmacodynamics-driven clinical trials program for primary brain tumors in the United States. To support the clinical trial program, a centralized CAP/CLIA certified Pharmacokinetics Core Laboratory is being developed with the mission of providing state-of-the-art bioanalytic technology and a broad range of pharmacology expertise to enable evaluation of critical pharmacological endpoints in clinical trials.
Summary of Position: PK Lab is currently in the process of CAP/CLIA certification and will be supporting healthcare professionals and patients in health management through accurate, precise and state of the art testing and research.Posting here. Best wishes to those interested.
We are looking for an individual to join the PK Lab team as a postdoctoral associate (at the level I, II and III depending on the experience). The candidate should have a strong background in pharmaceutical sciences and ideally in PK with a reasonable working knowledge in translational sciences. Candidates who have worked in the regulated environment to develop LC-MS/MS-based methods and can demonstrate competence in pharmacology and toxicology will be preferred. The candidate should be highly motivated, able to work well in teams, and have excellent communication skills. Potential areas of application include: drug PK, instrumental method development and validation, biomarker analysis, drug metabolism, PK analysis and modeling, medicinal or analytical chemistry.
3. Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans and test procedures designed to assure that components, drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b)).
Your firm failed to validate the Excel spreadsheet used to perform the assay calculation for your “[redacted].” Your procedures lacked guidance on how to check and manually verify the calculation sheets. During the inspection, our investigator identified a calculation error within the spreadsheet. The incorrect formula for averaging the Internal Standard peak area was used.
There is no assurance that the associated assay results recorded are reliable and accurate.
In your response, you stated that you have retrospectively tested products in the market using correct procedures and will update the validation master plan to ensure that spreadsheets are included within the scope of validation efforts. You created a new procedure which details the approach for validating spreadsheets as well as protecting the file from accidental changes. You also stated all Excel spreadsheet calculations for your [redacted] batches have been retrospectively reviewed.
During the review, you identified another error within your Excel spreadsheets. The assay test result for [redacted] batch [redacted] was incorrect due to a transcription entry error for active peak area. Your firm used a new spreadsheet and entered the correct active peak area. The result was recalculated, and the final result was reported. The product had already been released with test results using the incorrect calculation, although the recalculated test result was still within specification. You have committed to manually check calculations until the spreadsheet has been validated.
Your firm relied on Excel spreadsheets to calculate assay and determine the reportable result for final batch release. Your computerized systems must perform their functions satisfactorily and that your firm establish a written program to ensure ongoing proper system performance.
Your response is inadequate. You have not fully assessed the potential impact of using data from unvalidated, unsecured spreadsheets for critical CGMP functions.Excel spreadsheets are so useful, and who knew they had to be validated? (answer: lots of people)
WASHINGTON (January 21, 2020) – The Chemical Activity Barometer (CAB), a leading economic indicator created by the American Chemistry Council (ACC), jumped 0.6 percent in January on a three-month moving average (3MMA) basis following a 0.1 percent gain in December. On a year-over-year (Y/Y) basis, the barometer rose 1.4 percent.
The unadjusted January data showed a 1.0 percent gain following a 0.5 percent increase in December and a 0.4 percent gain in November. The diffusion index rose to 62 percent in January. The diffusion index marks the number of positive contributors relative to the total number of indicators monitored. The CAB reading for December was revised upward by 0.33 points and that for November was revised downward by 0.22 points.
“The CAB signals gains in U.S. commerce into the third quarter of 2020,” said Kevin Swift, chief economist at ACC.Well, that's good news. Here's hoping it keeps chemist jobs safe.
Residents catch truck dumping chemical waste into Vrishabhavati river
Alert residents of a gated community caught a truck driver trying to dump chemical waste into the Vrishabhavathi river on Saturday night.
The truck was seized and the keys were taken away by the residents. But, when the residents, accompanied by the beat police, went to the police station to file a complaint, the driver vanished along with the truck.
Nagaraju, Ramaraju, M.K. Kulkarni, C.J. Prakash, all residents of GoodEarth Orchard, noticed the truck belonging to a factory trying to dump the waste and caught hold of the driver. But he managed to escape....I'm sure there was a time when this was a problem in America, but I'm guessing it's not very common now...
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| Reactor part crashed through an apartment in Spain credit: Mossos/BBC |
MADRID (AP) — A massive explosion at a petrochemical plant in northeastern Spain on Tuesday killed one person and injured at least nine others, three seriously, regional authorities said.
A press spokesman for the port city of Tarragona, where the plant is located, said a preliminary investigation indicated the force of the blast killed an individual in a nearby neighborhood.
The spokesman said he had no further details. He spoke on condition of anonymity in keeping with City Hall regulations. The regional fire service tweeted that the man had died in a building affected by the blast. They said one other person was injured in the building.
The interior minister of Spain’s Catalonia region said eight workers at the factory were injured, three seriously, and one person remained missing....The video of the explosion is pretty horrifying, and the aftermath of the plant blast is awful. As someone who works in a plant environment, I am particularly haunted by the photograph above, which is a part of a reactor who killed a man in his apartment 3 kilometers away. We work in a dangerous business. Best wishes to all involved.
The University of Georgia Department of Chemistry (chem.uga.edu) invites applications for a tenure track faculty position in computational chemistry, beginning August 1, 2020, at the level of either Assistant or Associate Professor. Tenure upon appointment is possible at the associate level. All areas of computational chemistry will be considered, but priority will be given to candidates whose research interests complement existing expertise in the Center for Computational Quantum Chemistry (ccqc.uga.edu) and who can engage in collaborations with faculty within the Department of Chemistry and other units across campus, including the Center for Drug Discovery, the New Materials Institute, the Complex Carbohydrate Research Center, the Institute of Bioinformatics, the Department of Microbiology, and the Center for Tropical and Emerging Global Diseases.
The selected candidate will be appointed in an Assistant Professor or Associate
Professor. To be eligible for tenure upon appointment, candidates must be appointed as an associate professor, have been tenured at a prior institution, and bring a demonstrably national reputation to the institution. Candidates must be approved for tenure upon appointment before hire.
To receive full consideration, completed applications should be received by February 15, 2019.Best wishes to those interested.
The American labor market completed a decade-long marathon of hiring in the final month of 2019, and still shows few signs that it is running out of breath.
Payroll gains in December capped a year of steady but slowing gains in employment, the government reported Friday, nudging the year’s total past 2.1 million jobs. That was fewer than 2018’s additions but more than enough to outpace population growth.
“We had relatively strong and steady job growth over the year despite a number of headwinds including a trade war with China, weaker global activity and heightened policy uncertainty,” Gregory Daco, the chief United States economist at Oxford Economics, said. Employers added 145,000 workers in December.
Cooling job creation is normal in the 11th year of an economic expansion and a record-breaking streak of job gains. Looking ahead, Mr. Daco said the nation’s job machine was likely to crank down further.The chemical manufacturing subsector had 861600 employees in December 2019 (down 200 since November), 564500 production employees (up 1100) and the unemployment rate was flat at 1.2%. Not too shabby since the high of 10.3% or so in 2010.
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| Credit: @difluorine |
3. Your firm failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records (21 CFR 211.68(b)).
Our investigator observed your laboratory equipment lacked appropriate controls. For example, from January 1, 2018, to June 25, 2019, audit trails from [redacted] Agilent 1260 Infinity Series II high-performance liquid chromatography (HPLC) instruments showed a pattern of aborted runs and single run entries for testing [redacted]. Single run entries included analyses of multiple peaks or split peaks without documented investigations or adequate scientific justifications. Your employees used the Agilent Service Account login, with full administrative privileges, to abort HPLC testing runs without being attributable to a specific individual.
Your response identified the number of deleted, aborted, and single runs during your HPLC testing. However, your response did not provide adequate investigations or evidence of corrective actions put in place to prevent these data integrity issues from recurring.
