1. Your firm failed to maintain written production, control, or distribution records specifically associated with a batch of a drug product for at least one year after the expiration date of the batch (21 CFR 211.180(a)).
You manufactured drugs at your Wuhan facility at Building [redacted], No. 5, Kangda Street, Longyang Avenue, Hanyang District, Wuhan, and then transferred drug production to your Hubei facility and closed the Wuhan facility. Your firm failed to maintain manufacturing records, raw material and finished product testing records, retain samples, stability samples, and other CGMP records for your over-the-counter (OTC) [redacted] drug products manufactured at your Wuhan facility. During the inspection at the Hubei facility, you stated that you lost CGMP manufacturing documentation and drug product samples during the transfer of your manufacturing facility from Wuhan to Hubei in May 2018.Yep, happens all the time in moves. You put your batch records in the box, the box gets loaded onto a truck, stuff gets moved around, it gets lost!
Analytical chemist (BS/MS): CONTINUUS is looking to hire a full-time analytical chemist to work on the analysis of samples (mainly HPLC) from continuous manufacturing processes for small-molecule pharmaceuticals. This represents a unique opportunity to become involved in the development of next generation drug manufacturing technologies as a key member of a fast-growing company. The individual must thrive in a fast-paced environment, be adaptable and motivated by the opportunity to learn new technologies.
Flow chemist (PhD): CONTINUUS Pharmaceuticals is seeking a highly qualified flow chemist who will be responsible for developing creative solutions for small molecule drug candidates manufactured via continuous processing. This scientist will provide process analytical technology and continuous manufacturing expertise, devising synthetic routes and developing new technologies to enable continuous processing.Full ads here and here. Best wishes to those interested.
Postdoctoral Position in Chemical Biology of Natural Products The Burkart lab is seeking a natural product scientist to support chemical and structural biology studies of biosynthetic enzymes. Applicants should have a Ph.D. (or anticipated) in chemistry, biochemistry, or microbiology and have experience with molecular biology of metabolic pathways in Streptomyces or related microorganisms. This is a paid, full time, postdoctoral position based in the Department of Chemistry and Biochemistry at the main campus of University of California, San Diego in La Jolla, CA. For immediate consideration please send a cover letter and resume to Prof. Michael Burkart at mburkart@ucsd.edu.
GREENSBORO, N.C. — A Western Guilford High School student is in the hospital after an explosion in her chemistry class Wednesday. Aimee Green, 16, is a junior at the high school. She is listed in good condition at Wake Forest Baptist Medical Center, according to a spokesperson.
“Please pray for our beautiful daughter Aimee Green. She was in chemistry today, and the teacher was doing an experiment. It went badly and exploded. The explosion went right onto Aimee, and caught her hair, face, chest and arm on fire,” Aimee’s mom, Alicia Coverston Green, wrote on Facebook.
The experiment involved ethanol, alcohol and salt, Green said.
Green said her daughter was admitted to the burn ICU on Friday for fluid resuscitation, pain control and wound care.
Another student was injured but not as badly, officials with the school district said.Other reports indicate that it could not be confirmed that the student was wearing PPE.
According to the State Department, China has between 160,000 and 400,000 chemical companies operating legally, illegally or somewhere in between — an expansive estimate that reflects both the vastness of the industry and the scarcity of the information available. Some of these facilities manufacture tons of chemicals every week, or more than a million pills per day. In 2016, the industry made up 3 percent of China’s national economy, with over $100 billion in profits annually. Most of these companies are members of the vast pharmaceutical underclass, pumping out huge quantities of inexpensive generic drugs and pharmaceutical ingredients. It’s a low-cost, low-profit business, but the barriers to entry are minimal, and the market is immense: The basic pharmaceutical ingredients that China produces are needed by more advanced drug companies everywhere in the world — including the United States — for synthesis into more complex and profitable medicines.
The agency responsible for overseeing production of drugs and detecting malfeasance in China is understaffed and overwhelmed: As of 2017, there were around 2,000 inspectors at the agency, and they conducted a total of only 751 inspections that year, a minuscule figure compared with the enormousness of the industry. In the United States, law enforcement and prosecutors have the tools to react quickly to the rise of new copycat drugs that could be used for illicit purposes. Under the Controlled Substance Analogue Enforcement Act, passed in 1986, any new compound that is “substantially similar” to an already banned, or scheduled, drug can be treated as if it were chemically identical. But chemicals banned in the United States often remain legal in China, where the process for controlling chemicals is slow and cumbersome, especially for substances like fentanyl that exist in the purgatory between legitimate pharmaceuticals and illicit drugs.By comparison, an EPA web page last updated in 2016 indicates there are 13,500 chemical manufacturing facilities, with 9000 companies that own them. That's quite a difference.
As Amgen rides the wave of hype and hope for its early-stage KRAS effort as well as other cancer assets in its pipeline, this is pushing out its work on neuroscience.
To that end, the biopharma company is looking to slim down its efforts in that area, which could see nearly 200 jobs at risk, as it moves away from its neuro work in Cambridge, and focuses more on its R&D on the West Coast.Also, from last month in the Philadelphia Inquirer:
Merck, the international pharmaceutical giant, announced mass layoffs that will hit its sales personnel based in suburban Philadelphia.
About 500 people affiliated with Merck’s offices in Lansdale and Upper Gwynedd will lose their jobs in permanent reductions in force, the company said in a required letter it filed Wednesday with the Pennsylvania Department of Labor and Industry... Earlier this month, Johnson & Johnson said it planned to eliminate 297 employees at its Wayne facility, in a similar letter sent to the Department of Labor.
The American jobs engine has been beaten and battered, but it just keeps chugging along.
Employers added 128,000 jobs in October, the Labor Department said Friday, and revisions to prior months’ data tacked on another 95,000. The figures for October would have been stronger had it not been for the strike at General Motors, which shaved close to 50,000 workers from the employment rolls, and for the layoff of some 20,000 temporary census workers.
The unemployment rate ticked up to 3.6 percent, still near a half-century low.If we're going to have a classic recession, we'll see decreases in jobs in November and December. While my intuitions are entirely leaning towards the thought that there will be a recession of some kind next year (i.e. visible declines in the topline jobs numbers and/or negative quarters of GDP), we haven't seen those signs yet in the broader economy. It will be very interesting to see if we see evidence of declines in hiring in the chemistry/pharma market.
BACKGROUND
We are a fast-moving, high-growth chemical technology startup that is developing a process to turn old clothing into new textiles. Our highly dynamic, collaborative team is composed of the world’s brightest and most unique scientists and engineers.
THE JOB
We are looking for a highly motivated scientist who will develop and scale our technology for making brand new yarns from old clothing.
You will be working with senior leadership to understand and prioritize process improvements, design experiments to make those improvements, and execute these plans in the laboratory. You will develop analytical methods for R&D as well as scale-up, and develop new products within our R&D team. You will use your chemistry know-how to work with engineers and scale-up processes.
You are detail oriented and highly enthusiastic about science and scaling a first-in-kind sustainable process. Ideally, you have a strong experimental background and commanding knowledge of physical, organic, and polymer chemistry.
Specific techniques required: GPC/SEC, DSC, GC/MS, working knowledge of elemental analysis. Adequate safety know-how is an absolute must. You must be comfortable in a fast-paced, open environment with minimal direction.Contact information here. Best wishes to those information.
Junior Process Chemist, Quanta BioDesign
Quanta BioDesign is a research and manufacturing company committed to the development of a full range of discrete polyethylene glycol (dPEG®) PEGylation reagents for applications in diagnostics, therapeutics, peptide synthesis, oligonucleotide synthesis, and nanotechnology.
To meet our growing business demands we are currently seeking to fill the position of a junior Process Chemist. The Process Chemist position entails being an essential part of our process and scale-up activities, supplying key intermediates, optimizing existing processes and exploring a growing range of new processes for making our unique dPEG® products.
The process Chemist interacts with chemists both in and outside their group, and will be a vital link in the development of the dPEG® technology. As a result, excellent planning and problem-solving skills are a critical aspect of this position. Also, since this is a manufacturing position the Chemist must be capable of lifting up to 50lbs on a regular basis.
Qualifications
JOB DESCRIPTION
The Anagnostopoulos Research Group at the Department of Chemistry at the University of Central Florida seeks to hire a postdoctoral researcher in the field of radiochemistry and environmental radiochemistry.
This is a multi-faceted project that focuses on the oxidative dissolution of sparingly soluble radioactive phases, as well as synthesis, characterization and stability studies of mineral phases for the incorporation of anionic contaminants.
REQUIREMENTS
Applicants should have a Ph.D. in chemistry or closely related field. Prior demonstrated experience with spectroscopic analysis of solids and solutions (e.g. XPS, FIB, SIMS etc.) and processes such as solubility, complexation and modelling and speciation will be viewed favorably.Full ad here. Best wishes to those interested.
