Warning Letter of the Week: non-uniformity edition

A love note for the CEO of Mylan Pharmaceuticals from the Center for Drug Evaluation and Research:

2. Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192). 

Your investigations into out-of-specification (OOS) results and process deviations were inadequate. Root causes did not consistently include scientifically supported conclusions.... 

B. Your firm opened two manufacturing investigation reports, No. 1071629 on December 12, 2016, and No. 1106258 on January 25, 2017, to investigate atypically high assay and high variability content uniformity results for three batches of prednisolone sodium phosphate 10 mg orally disintegrating tablets (ODT). The investigations identified a root cause of untrained or inexperienced operators [redacted]. The investigation did not fully evaluate the processing factors that contribute to variability in your finished tablets. In particular, it did not evaluate the inherent variability of the [redacted] method used for charging [redacted], and identify more robust methods for performing this critical transfer that could prevent blend segregation and tablet dose non-uniformity. It also did not ensure improvements were adequately specified in batch records to enable an ongoing state of control. We acknowledge your firm’s market recall on April 30, 2018, of all batches of prednisolone sodium phosphate ODT within expiry from the U.S. market. 

C. Your firm opened multiple manufacturing investigation reports and trending assessments from July 2016 to October 2017 related to out-of-trend and OOS content uniformity results for metolazone 2.5 mg tablets. A scientifically justified root cause had not been identified, and effective CAPA plans had not been implemented. Despite substantial non-uniformity observed in multiple batches of metolazone 2.5 mg tablets, you continued to manufacture and release this drug product up to the time of the inspection.

I don't know anything about tableting, but I bet that non-uniformity isn't a fun problem to solve.

This week's C&EN

A few of the articles in this week's issue of Chemical and Engineering News:

• Cover: "The chemical search for better white light" (by Mitch Jacoby)
• "Introducing the new Dow" (by Alex Tullo) 
• Blockchain! (by Neil Savage)
• looking forward to the American Chemical Society coming up with ACSCoin in three years
• Noramco is making synthetic THC? (by Michael McCoy) 
• Some d00d yapping about professional jealousy
• I dunno, "meta-meat" doesn't sound very tasty 

The 2019 Chemistry Faculty Jobs List: 468 positions

The 2019 Chemistry Faculty Jobs List (curated by Andrew Spaeth and myself) has 468 positions.

Want to help out? Here's a Google Form to enter positions.

On November 21, 2017, the 2018 Chemistry Faculty Jobs List had 441 positions. The latest weather report for the Faculty Jobs List is here.

Interested in how this is tracking overall? Check out these sweet graphics done by Andrew Spaeth.

Want to chat? Here's the current open thread. Here's the pre-September thread, here's the September/October thread.

Otherwise, all discussions are on the Chemistry Faculty Jobs List webforum.

The Chemical Engineering Faculty Jobs List: 49 positions

The Chemical Engineering Faculty Jobs List has 49 positions. It is curated by Lilian Josephson (@lljosephson). 

The Academic Staff Jobs List: 21 positions

The Academic Staff Jobs list has 21 positions.

This list is curated by Sarah Cady. It targets:

• Full-time STAFF positions in a Chem/Biochem/ChemE lab/facility at an academic institution/natl lab
• Lab Coordinator positions for research groups or undergraduate labs 
• and for an institution in Canada or the United States

Want to help out? Here's a Google Form to enter positions.

Want to chat about staff scientist positions? Try the open thread.

‘My friend, sorry, you must wait.’

An amusing aside in a New York Times article about luxury brands and their supply chains: 

Parterre, the British fragrance house, created its own on-site botanical garden at Keyneston Mill in Dorset, England, to grow the aromatic plants that would form the cornerstone of its limited-edition fragrances. Much the same instinct underpins the rise of cottage gardens at high-end hotels like Borgo Santo Pietro in Tuscany, Italy. Its Michelin-starred restaurant relies primarily on the organic farm attached to the property, which includes a dairy and an apiary. 

“They are securing the sources of their competitive advantage,” said Mario Ortelli, a luxury analyst with Ortelli & Company of London. “If your supplier works with 10 other luxury brands, and you’re not the most important client? When you ask for extra quantities, he can tell you, ‘My friend, sorry, you must wait.’”

It'd be interesting to know if Parterre purchased its own extraction as well? 

Kalrez o-rings

A list of small, useful things (links):

• The latest from Stellen für Chemiker
• The latest from All Things Metathesis
• Do check out the Organic Chemistry Jobs Company List - I think it's a neat idea
• At Sustainable Nano, Zack's Nano Adventure
• Ash, on an AI-in-chemistry poll
• xykademiqz on postdocs
• naturalproductman, on "The Synthesis of 12alpha-Hydroxy Steroids"
• Interesting essay on professor semi-retirement, by Richard C. Larson (submitted by friend-of-the-blog James Ashenhurst)
• 133 people have died from being pulled into a wood chipper in the last 9 years? (by Celeste Monforton)
• Interesting essay on alcoholism in graduate school (by Elizabeth A. Marchio)

An open invitation to all interested in writing a blog, a hobby that will bring you millions thousands hundreds tens of dollars joy and happiness. Send me a link to your post, and I'd be happy to put it up.

Have a good weekend!

Job posting: Director, Chemical Laboratory - NMR Lab, Auburn University, Auburn, AL

From the inbox:

The Department of Chemistry and Biochemistry at Auburn University seeks to fill the position of Director of Chemical Laboratories for Nuclear Magnetic Resonance (NMR) Lab. Responsibilities include, but are not limited to: (1) operating and maintaining the Department of Chemistry and Biochemistry's 250 MHz, 400 MHz, and 600 MHz NMR spectrometers; (2) maintaining the computers and software needed to run the NMR instrumentation and data processing stations; (3) running samples and assisting researchers with data analysis and experimental design; (4) supervising a graduate student who will assist in the operation of the laboratory; and (5) billing for services pertaining to the NMR spectrometers.   

The following are minimum qualifications: (1) a Ph.D. from an accredited institution in NMR Spectroscopy, Chemistry, Biochemistry, or a closely related field, (2) five (5) years of experience in analyzing (bio)chemical molecules and coordinating lab operations, procedures, and instruction, and (3) knowledge of laboratory techniques, safety procedures, and teaching principles. 

Full job posting here. Best wishes to those interested. 

The Medicinal Chemist Jobs List: 246 positions

The Medicinal Chemist Jobs list (curated by Joel Walker and myself) has 246 positions.

Want to help out? Here's a Google Form to enter positions, but if you want to do the traditional "leave a link in the comments", that works, too.

Want to chat about medchem positions? Try the open thread.

Positions I'm not including: positions outside the United States, computational positions (this will likely change), academic positions (likely never.)

The Analytical Chemistry Jobs List: 10 positions

The Analytical Chemistry Jobs List has 10 positions; this is curated by the ACS Division of Analytical Chemistry. Want to help out? Fill out this form. 

The Organic Chemistry Jobs Company List

Over at Organic Chemistry Jobs, a pretty neat new list: the Organic Chemistry Jobs company list.

29 new positions at Organic Chemistry Jobs

Over at Common Organic Chemistry, there's 14 new positions posted for November 14 and 15 positions posted on November 12. 

The Process Chemistry Jobs List: 245 positions

The Process Chemistry Jobs List has 245 positions.

Want to help? Here's a form to fill out.

Want to chat process jobs? Try the open thread. 

Coke dissolves road dust?

Via the New York Times, this odd little article about using food as cleaning agents, including the classic 101 uses for Coca-Cola: 

...Speaking of sticky things, our reader Peggy offers this suggestion: “I use a product called Goo Gone but its main ingredient is orange oil. If you have no Goo Gone, rub a piece of orange on the gunk from stick-on labels and Bob’s your uncle.” 

Ketchup — yes, it’s a vegetable, just go with us — can be used to polish brass and copper. But if you’re out, and you happen to have a pineapple handy, you’re in luck. 

“Whenever I trim a pineapple, I grab a saltshaker and whichever of my copper bottom pots needs tarnish removed: Sprinkle salt, rub with pineapple peel — Voilà!” wrote another reader.... 

...We noted that Coca-Cola can be used to clear a slow-moving drain, clean a toilet bowl and remove motor oil and grease from clothing and pavement. You all had many uses to add. Bill writes: “If road oil and dust have made your windshield smeary, pour Coke on it. The windshield comes clean,” and Thomas added, “Coke rejuvenates old windshield wiper blades.”

Orange oil as a handy solvent makes sense to me, but ketchup to remove metal oxides? Also carbonated sugar water for motor oil?  

This week's C&EN

A few of the articles from this week's issue of Chemical and Engineering News:

• Cover: "Making biologics on demand" (by Celia Henry Arnaud)
• This Mark Peplow piece on a rather unfortunate situation at the University of Manchester is worth a read 
• Rick Mullin with two articles on Hovione 
• I really enjoyed this profile of Diane Villax
• Anne McNeil's new website: DiversifyChemistry (article by Linda Wang)
• Finally time for antisense oligonucleotides? (article by Ryan Cross)

The 2019 Chemistry Faculty Jobs List: 458 positions

The 2019 Chemistry Faculty Jobs List (curated by Andrew Spaeth and myself) has 458 positions.

Want to help out? Here's a Google Form to enter positions.

On November 14, 2017, the 2018 Chemistry Faculty Jobs List had 429 positions. The latest weather report for the Faculty Jobs List is here.

Interested in how this is tracking overall? Check out these sweet graphics done by Andrew Spaeth.

Want to chat? Here's the current open thread. Here's the pre-September thread, here's the September/October thread.

Otherwise, all discussions are on the Chemistry Faculty Jobs List webforum.

The Chemical Engineering Faculty Jobs List: 49 positions

The Chemical Engineering Faculty Jobs List has 49 positions. It is curated by Lilian Josephson (@lljosephson). 

The Academic Staff Jobs List: 21 positions

The Academic Staff Jobs list has 21 positions.

This list is curated by Sarah Cady. It targets:

• Full-time STAFF positions in a Chem/Biochem/ChemE lab/facility at an academic institution/natl lab
• Lab Coordinator positions for research groups or undergraduate labs 
• and for an institution in Canada or the United States

Want to help out? Here's a Google Form to enter positions.

Want to chat about staff scientist positions? Try the open thread.