Warning Letter of the Week: inadequate investigation edition

A friendly note to the Executive Vice President of Zhejiang Huahai Pharmaceutical Co., Ltd. from the Center for Drug Evaluation and Research:

1.      Failure of your quality unit to ensure that quality-related complaints are investigated and resolved. 

Your firm received a complaint from a customer on June 6, 2018, after an unknown peak was detected during residual solvents testing for valsartan API manufactured at your facility. The unknown peak was identified as the probable human carcinogen N-nitrosodimethylamine (NDMA). Your investigation (DCE-18001) determined that the presence of NDMA was caused by the convergence of three process-related factors, one factor being the use of the solvent [redacted]). Your investigation concluded that only one valsartan manufacturing process (referred to as the [redacted] process in your investigation) was impacted by the presence of NDMA.

However, FDA analyses of samples of your API, and finished drug product manufactured with your API, identified NDMA in multiple batches manufactured with a different process, namely the [redacted] process, which did not use the solvent [redacted]. These data demonstrate that your investigation was inadequate and failed to resolve the control and presence of NDMA in valsartan API distributed to customers.... 

...Your response states that NDMA was difficult to detect. However, if you had investigated further, you may have found indicators in your residual solvent chromatograms alerting you to the presence of NDMA. For example, you told our investigators you were aware of a peak that eluted after the [redacted] peak in valsartan API residual solvent chromatograms where the presence of NDMA was suspected to elute. At the time of testing, you considered this unidentified peak to be noise and investigated no further. Additionally, residual solvent chromatograms for valsartan API validation batches manufactured using your [redacted] process, with [redacted] in 2012 ([redacted], and [redacted]) show at least one unidentified peak eluting after the [redacted] peak in the area where the presence of NDMA was suspected to elute....

It's never good when other people can find evidence in your own data that you missed....  

Woman chemistry professor sues University of Arizona

Via AZCentral, this news:

A University of Arizona chemistry professor has filed a class-action lawsuit alleging gender discrimination in pay and promotions at the Tucson campus. 

Dr. Katrina Miranda, a tenured associate professor in the school's Department of Chemistry and Biochemistry, claims in a lawsuit filed in U.S. District Court on Nov. 29 that there's a pattern of systematic discrimination against female faculty members in UA's College of Science. "Dr. Miranda has suffered substantial pay disparities as compared to her male counterparts, and the university has failed to promote her in an equivalent manner to these male peers," the lawsuit says. 

Miranda has worked at the university since 2002 and received tenure in 2008. The Arizona Board of Regents is named as the defendant in the lawsuit, as the board oversees UA. 

...The lawsuit estimates Miranda was underpaid by $9,000 to $36,000 per year from 2016 to 2018 compared with male professors of "similar or lesser seniority and performance." Miranda was paid about $100,000 for the 2017-18 academic year, while a male chemistry professor made $130,500 despite joining the university and getting tenure the same year as Miranda, the lawsuit claims. Another male chemistry professor with one year of experience more than Miranda made more than $136,000, according to the court filing. 

It will be interesting to see how this proceeds in court. (Isn't professor pay at public universities public? I wonder at what point this lawsuit went from "I think this is unfair" to "I'm gonna call a lawyer.") 

The 2019 Chemistry Faculty Jobs List: 502 positions

The 2019 Chemistry Faculty Jobs List (curated by Andrew Spaeth and myself) has 502 positions.

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

On December 12, 2017, the 2018 Chemistry Faculty Jobs List had 465 positions.

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

Want to chat? Here's a link to the current open thread. Here's the October/November 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: 29 positions

The Academic Staff Jobs list has 29 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.

Steel bolts

A list of small, useful things (links):

• The latest from Stellen für Chemiker
• The latest from All Things Metathesis
• At Sustainable Nano, Nano-textiles: The Fabric of the Future
• The death of the kilogram (by XiaoZhi Lim)
• Good comments at In the Pipeline about AMRI/Lilly
• Good essay about grad school depression
• Thoughts from Stu Cantrill about promethium
• Neal Anderson on smelly impurities
• Interesting post on science poetry

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 of Science and R&D, Centuria Foods, Carson City, Nevada

From the inbox:

Centuria Foods is hiring a Director of Science and R&D for our new operations in northern Nevada. If you want to make a strong impact on a thriving company that is still in its startup growth stage, this position at Centuria may be for you.  It will be challenging as goals, roles, and projects will be shifting as priorities change based on internal and external factors. This means you can and will need to adapt quickly, prioritize and begin new projects based on your own initiative, and communicate effectively with colleagues that do not necessarily think or speak as you do.  

Please review the requirements below. We are admittedly looking for a rock star. But if you happen to have the listed skills, we want to speak with you.

Strong applicable scientific knowledge:  Must have hands-on experience in large scale separation science, including the principles of partition, distillation and chromatography. An understanding of cross flow filtration and countercurrent chromatography desired.  

Problem solver: Must show adaptability to handle the random issues that plague complicated equipment.
cGMP: Is well versed in cGMP regulations as per ICH Q7 guidelines.
Aptitude for solving problems when working with equipment: Having experience in the construction and/or maintenance of large scale process equipment is preferred.
Safety is key: Have knowledge of state and federal OSHA regulations, and must demonstrate a commitment to safe practices.
Communication skills: The successful candidate must be able to translate complex concepts to non-scientist colleagues.
Leadership skills: Will be expected to lead the hiring for personnel in his/her group and train and manage them to excel.
Curiosity: Can cite past accomplishments showing natural curiosity to learn new subject matter and solve hard problems.
Startup experience: Can thrive in the controlled chaos of a startup environment
Preferred background: BS/MS process engineer or chemist from the biotech, pharma, or petrochemical industries 

CompensationMarket or above market salary depending on experience
Stock options at one of the strongest industrial hemp CBD companies in North America
Full health benefits and vacation

Link here. Best wishes to those interested. 

Job posting: fermentation scientist, C16 Biosciences, Somerville, MA

From the inbox:

Fermentation Scientist 

C16 Biosciences seeks an outstanding chemical engineer to lead our fermentation-based bioprocess efforts and to successfully scale this process from the bench to demonstration scale. 

C16 Biosciences makes lab-grown palm oil. Palm oil is a bedrock component of the modern economy ($60B/yr market size, found in 50% of consumer goods), but its production drives massive amounts of deforestation, extinction, and greenhouse gas emissions. We provide a sustainable alternative to palm oil by using microbial fermentation to convert sustainable carbon streams into lipids which match or beat the performance of palm oil.  We are a Y Combinator and venture capital backed company based in Somerville, MA.  The successful candidate will lead the development, optimization, and scaling of our full bioprocess.  

The primary focus in this role will be to lead the fermentation of sustainable carbon streams using C16 Bioscience’s proprietary microbial strains. Responsibilities include: 

• Lead, design and execute fermentation optimization and scale up experiments 
• Prioritize, plan and direct projects to ensure cost-effective and scalable bioprocess
• Define and analyze data from fermentation runs, incorporating results to improve bioprocess
• Optimize lipid extraction and purification from fermented biomass
• Manage downstream processing and derivatization of microbial oils
• Develop and optimize conditions for product validation
• Lead scale up of bioprocess and transfer to manufacturing, including development of and effective application of SOPs
• Proactively identify new partnerships and grow existing relationships with CMOs
• Develop and manage technology transfer to guarantee effective, accurate high-impact CMO pilots

Requirements:

• Degree in Chemical Engineering, Mechanical Engineering, Biological Engineering, or related field
• >5 years experience working on fermentation bioprocess development

Full ad here. Best wishes for those interested. 

The Medicinal Chemist Jobs List: 251 positions

The Medicinal Chemist Jobs list (curated by Joel Walker and myself) has 251 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. 

30 new positions at Organic Chemistry Jobs

Over at Common Organic Chemistry, there's 11 new positions posted for December 3 and 19 positions posted on November 30. 

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. 

The 2017 ACS Form 990

This was 2017's form 990. (Here are the other ones: 2016, 2015 and 2014.)

ACS executive director Thomas Connelly made $893,157 in 2016. Looks like he made $991,787 in 2017. 10.9% increase, must have been a good year.

Whoa: Rhine River shuts down BASF plant

Also in this week's Chemical and Engineering News (by Alex Scott):

Problems caused by low water levels on the Rhine River have gone from bad to worse for German chemical companies. 

BASF says it has closed its toluene diisocyanate facility in Ludwigshafen, Germany—several hundred kilometers up the Rhine from the North Sea—because record low water levels are preventing barges from delivering enough raw material. BASF says it had to shut the polyurethane chemical plant despite transferring as many shipments as it can from the river to pipeline, trucks, and rail. Restarting the plant will depend on improved water levels, BASF says, adding that it has no plans to shut any other plants. 

The low water is affecting many German chemical companies dotting the Rhine as well as firms further upriver in Switzerland. Rather than recover from low flow during a dry summer, river levels have continued to drop...

Uh, wow.  

This week's C&EN

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

• The Year in Pharma
• Don't miss Lisa Jarvis' article about Civica, a consortium attempting to solve chronic shortages in generic drugs
• I think this topic is fascinating and undercovered. 
• Is it market failure? or just a response to the difficulty of manufacturing a highly-regulated product? 
• Variability in Alzheimer's genes? This is bad, yeah? (by Megha Satyanarayana)
• Self-driving lab instruments? Students learn to use them. (by Sam Lemonick)
• The 2018 #RealTimeChem Week Awards (by Dorea Reeser)

The 2019 Chemistry Faculty Jobs List: 486 positions

The 2019 Chemistry Faculty Jobs List (curated by Andrew Spaeth and myself) has 486 positions.

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

On December 5, 2017, the 2018 Chemistry Faculty Jobs List had 456 positions.

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

Want to chat? Here's a link to the current open thread. Here's the October/November 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: 29 positions

The Academic Staff Jobs list has 29 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.

What will 2019 look like for layoffs?

Many of you heard the news about Bayer AG's layoffs last week (article via Bloomberg):  

Bayer AG plans to cut 12,000 jobs and exit its animal health business in an effort to mollify Wall Street, which has punished the company over the tidal wave of lawsuits that came alongside the $63 billion takeover of Monsanto Co. 

...Of the 12,000 job cuts, half will probably come from corporate and supporting functions while another third will be in crop science as the Monsanto integration proceeds, Bayer said. Another 1,250 positions will probably come from pharmaceuticals -- with 350 related to a new facility in Wuppertal, Germany. Another 1,100 will be cut in Bayer’s consumer health division. Baumann repeatedly declined to say how many of the reductions would be in Germany overall....

Also, there was this news last week from Chemical and Engineering News (article by Alex Scott) 

BASF has unveiled a company-wide reorganization in a bid to hike profits by $2.3 billion annually by 2021, the equivalent of increasing pretax profits by between 3 and 5% per year. The firm also aims to increase annual sales of products it claims make a substantial contribution to sustainability to $25 billion by 2025... 

...As part of its restructuring, the firm aims to enhance efficiencies in production, logistics, and R&D. This will include moving some of the firm’s centralized R&D activities into business units. Other planned changes include the wider use of digitization and automation. The firm will invest about $460 million annually on efficiency improvements—significantly more than it has spent in previous years. 

The restructuring will impact about 20,000 of the firm’s 115,000 employees, but BASF will not necessarily cut jobs, according to Brudermüller. Although efficiency improvements will be needed, more staff will be required to implement the planned growth of the business, Brudermüller said.

I feel like 2015 through 2018 were pretty good years for hiring in pharma, certainly something close to a local maxima. Here's hoping that 2019 brings good news rather than bad. Readers, what do you think?