|Credit: Indrek Kalvet|
(got a View from Your Hood submission? Send it in (with a caption and preference for name/anonymity, please) at firstname.lastname@example.org; will run every other Friday.)
1. HELPING CHEMISTS FIND JOBS IN A TOUGH MARKET. 2. TOWARDS A QUANTITATIVE UNDERSTANDING OF THE QUALITY OF THE CHEMISTRY JOB MARKET.
|Credit: Indrek Kalvet|
2. Your firm failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products (21 CFR 211.22(a)).
Your quality unit failed to exercise its authority to approve, release, and distribute OTC drug products before all analytical testing was completed and reviewed. In addition, your firm approved and released OTC drug products that did not meet their final specification. For example:
In your response, you provided an updated standard operating procedure and the associated training records concerning the release of OTC drug products with inadequate quality oversight. However, your response is inadequate because you have not determined the root cause of this violation.Eh, the assay probably would have shown the material to be in spec anyway... ship it!
A postdoctoral position will be opening in the Korendovych lab at Syracuse University, subject to final approval by HR. The lab’s major foci include designing self-assembling peptides for catalysis (e.g. Nat. Chem. 2014, 303; ACIE 2016, 9017 and ACS Cat. 2018, 59) and minimalist design and directed evolution of protein catalysts (e.g. JACS 2015, 14905; ACIE 2013, 6246, Nat. Commun. 2017, 14876).
Experience in peptide synthesis and characterization, familiarity with spectroscopy, biophysical characterization techniques, recombinant protein expression and ability to handle air sensitive samples are desirable. Most importantly, the Korendovych lab is looking for an energetic, motivated, critically thinking individual.
Interested candidates should contact me directly at email@example.com.Best wishes to those interested.
VISITING ASSISTANT PROFESSOR IN CHEMISTRY and INSTRUCTOR IN CHEMISTRY at DAVIDSON COLLEGE
The Chemistry Department at Davidson College invites applications for a two-year visiting position in chemistry at the Assistant Professor level and a two-year visiting position in Chemistry at the Instructor level to both begin July 1, 2019.
Details regarding the chemistry program can be found on the department website (http://www.davidson.edu/academics/chemistry). Please direct inquiries to Durwin Striplin, Professor and Chair of Chemistry, at firstname.lastname@example.org. Only online applications submitted to http://employment.davidson.edu will be considered. More detailed information can be found on the employment site at Davidson College.
At Davidson College, we believe the college grows stronger by recruiting and retaining a diverse faculty and staff committed to building an inclusive community. In order to achieve and sustain educational excellence, we seek to hire talented faculty and staff across the intersections of diverse races, ethnicities, religions, sexual orientations, gender identities, ages, socio-economic backgrounds, political perspectives, abilities, cultures, and national origins.Best wishes to those interested.
The Association of the British Pharmaceutical Industry is warning that the UK needs to fill an increasing number of science skills gaps in order to retain its prominent position for medicines and vaccines research and development....
...“We have long been concerned by the skills gap in clinical pharmacology, as identified in the ABPI’s report. These skills are crucial for leading research and clinical trials, and for ensuring the best healthcare for patients,” commented Dr Anna Zecharia, director of Policy at the British Pharmacological Society.
To help address the situation, the trade association says it is working with allied organisations, including the British Science Association, to inspire more young people to pursue STEM careers, and is involved in the development of standards for a new high-level Clinical Pharmacology Scientist apprenticeship.This situation is terrible, which is why we're (checks notes) talking to pre-college students about studying STEM, making sure that our solution is at least 4 years out?
2. Your firm failed to establish and document the accuracy, sensitivity, specificity, and reproducibility of its test methods (21 CFR 211.165(e)).I guess "uh, we'll have someone else do the QC testing" won't fly as an excuse.
Your firm did not validate analytical test methods used to determine assay for the active ingredients in your drug product before release for distribution. Your notebook and high-performance liquid chromatography (HPLC) report included different instrumentation parameters for the same active ingredient analysis. For example, in the HPLC report the flow rate and injection amount for biotin was [redacted] mL/[redacted] and [redacted] µL, while in the notebook these parameters were recorded as [redacted] mL/[redacted] and [redacted] µL.
In your response, you stated, “In the main component analysis, other components besides the main component will be subjected to quantitative analysis and qualitative analysis through an external analysis institution”.
Your response is inadequate because you did not provide sufficient information regarding the validation of your test methods, including a timeframe to complete method validation and which analyses your third-party will be conducting. You also did not provide an interim plan of action.
What's the job market like for chemists? Dude -- it's always bad.*
How bad is it? How the heck should I know? Quantifying the chemistry job market is what this blog is about. That, and helping chemists find jobs.
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(*For the literal-minded, this is a joke. Mostly.)