Life Scientists:Looking for a Job? Consider the Cannabis Industry

Posted in BioBusiness, Career Advice

According to a recent article, the 2013 to 2014 US market for legal Cannabis (medical and recreational) grew 74% from $1.3 billion to $2.7 billion. Industry analysts predict that the legal marijuana industry is (and will continue to be) the fastest-growing industry in the US over the next 5 years with annual revenues topping $11 billion by 2020.  And, as the industry grows so will employment opportunities. At present, salaries associated with various job functions in the Cannabis industry range from $50,000 to $90,000. As many businesses that support the Cannabis industry continue to grow, the competition for qualified employed will intensify and salaries will concomitantly rise. Currently,, there aren’t enough trained job candidates to fill the many job openings at Cannabis companies. I am sure that many of you who hold graduate degrees in the life sciences are wondering why I am pitching jobs in the Cannabis industry.

First, traditional jobs for PhD-trained life scientist are getting scarcer and the election of Donald Trump suggests that this trend will not be reversed anytime soon.

Second, consider that growing and cultivating marijuana and extracting cannabinoids (the pharmaceutically active molecules in Cannabis buds) require a background in laboratory methods, chemistry, biology and in some cases plant science. For those of you who may not know, the medical Cannabis market is focusing almost exclusively on cannabis extracts and vaporization of these extracts (rather than smoking) is the preferred delivery methods. This suggests that those of you with backgrounds in biomedical engineering and medical devices  can leverage your expertise and skills to obtain jobs in the delivery side of the cannabis industry.  

Third, the expansive growth and sheer economic size of the Cannabis industry suggests that other jobs that require a life science background are likely to emerge. These include quality control/assurance jobs for strain identification, diagnostic jobs to determine THC levels/intoxication, molecular biology and bioinformatic jobs to continue to explore and unlike therapeutically relevant molecules from the Cannabis genome and synthetic biology jobs to increase cannabinoid yields and reduce production costs. Finally, there is currently a dearth of qualified job candidates with scientific backgrounds to fill entry level grow and extraction jobs in the Cannabis industry.

At present, the industry is mainly dominated by long time Cannabis growers, people who use marijuana on a regular basis and some moxy business people/investors who see an an enormous upside for the Cannabis industry. Put simply, now is the time to get in on the ground floor of an industry that is exploding and will ultimately become a legal multibillion dollar a year industry. While I’m sure that neither you nor your parents/family envisioned a career in Cannabis, the jobs are there and ripe for the picking (pun intended).

Until next time…

Good Luck and Good Job Hunting!!!!!!!!!!!

Regulatory Affairs Update; FDA 483 and Warning Letters Trends for 2012

Posted in BioEducation

Those of you who manufacture products approved by the US Food and Drug Administration (FDA) are well aware of the importance of complying with Current Good Manufacturing Practices (cGMP) during FDA mandated inspections of your manufacturing facilities. Failure to comply with cGMP requirements during an inspections results in the issuance of 483s. And if you fail to adequately address the concerns of the agency outlined in 483s, it may ultimately result in issuance of warning letter to your company.

FDA is more vigilant and aggressive than ever before with its 483 and warning letter enforcement procedures. In the words of Commissioner Margaret Hamburg, FDA is quick, visible and vigilant.  With this in mind, it may be worthwhile to participate in a webinar offered by Expert Briefings.com entitled “Top Compliance Trends for 483 and Warning Letters for 2012—Based on Rare FDA Data.”

The webinar will be held on March 8, 2012 from 2:00-3:30 PM EST and Dennis Moore, Managing Partner, AUK Technical Services and a 28 year veteran FDA investigator will lead it. 

Topics to be covered include:

  • Top warning letter trends for 2012, such as more 806 enforcement
  • The Top 10 QS 483 Observations for 2010 and 2011
  • Most common quality system failures for drugs for 2010
  • Top drug and device citations in 483s for 2010
  • Top drug and device warning letter citations for 2010
  • Total 2010 BIMO inspections for CDER, CBER, CDRH, and CVM
  • Details on clinical investigator, sponsor/monitor and IRB audits for 2010
  • Most common sponsor deficiencies for 2010
  • The rising trend of ‘cease to market’ letters, one of which hit a NY pharma company in 2011
  • The total number of 483s issued in 2010 and 2011 – an all time high
  • Total CAPA 483 observations in 2010
  • How long to receive a warning letter, based upon which offices issues it
  • 483 inspection targets for drugs and devices for 2010, 2011, and 2012
  • Total warning letters issued by drug and device category in 2010
  • Which district offices write the most warning letters
  • How long to receive a warning letter, based upon issuing office
  • Warning letters issued by QS system for 2010
  • 483s broken down by QS subsystem for 2010
  • Warning letters by CFR section
  • Top device 483 observations for 2010
  • Details on process validation observations for 2010
  • Design control 483 observations by category for 2010
  • Click here to visit Expertbriefings.com.

Click here to visit Expertbriefings.com.

I hope to see (hear ?) you at the webinar!

 

Abbott Slashes 700 Jobs From Its Medical Devices and Diagnostics Unit

Posted in BioEducation

Chicago-based Abbott Laboratories today announced that it would lay off 700 employees from its medical devices and diagnostics division as part of an ongoing restructuring effort. 

Most of the layoffs will take place in the Chicago area and affect employees that manufacture the company’s cardiovascular stents and diagnostic tests. According to a company spokesperson approximately 500 persons who work in stent manufacturing and 200 who work in diagnostics will lose their jobs.

The restructuring of Abbott’s manufacturing operations began several years ago and about this time last year the company layed off about 1,900 employees in Lake County, Illinois.

In October, Abbott surprised investors and analysts with the announcement that it would spin off its branded drug business, including Humira (psoriasis and rheumatoid arthritis) it’s largest selling branded pharmaceutical product. Company executives argued that the split would allow stakeholders and investors to separately and more accurately value Abbott’s other less risky businesses which include nutritional (baby) formula, generic drugs and medical devices and diagnostics.

Despite signs of economic recovery, it appears that layoffs are still occurring at a pretty good clip at many pharma and biotech companies. It now appears that medical devices and diagnostic company employees, who were once immune to downsizing and reorganization, are now fair game.

Until next time…

Good Luck and Good Job Hunting!!!!

 

Maximizing Patient Engagement During Clinical Trials

Posted in BioBusiness

Recruiting, retaining and managing patients that participate in clinical trials for approval of new medicines and devices have becoming very challenging in the past decade or more. Ironically, the ready availability of experimental new medicines in the US for certain therapeutic areas including oncology, neuroscience and vaccines have forced life sciences companies and CROs to conduct many Phase I and Phase II trials outside of the US. In turn, the globalization of clinical trials has forced many sponsors to increasingly rely on e-based and mobile solutions for patient recruitment, retention and compliance.

The Advance Learning Institute’s conference entitled “Patient Recruitment, Compliance And Retention For Clinical Trials: Integrating The Latest Technologies With Traditional Tools To Maximize Patient Engagement” that will be held in Manhattan on October 24-26, 2011 will provide attendees with insights into the best practices to maximize patient engaged in clinical trials. Presentations will be given by a variety of pharmaceutical companies, CROs and academic institutions including Pfizer, Merck Research Laboratories, Shire Pharmaceuticals, Celgene Corporation, Quintiles, Omniscience Mobile, Albert Einstein College of Medicine and the Michael J. Fox Foundation for Parkinson’s Research. A complete agenda for the conference can be found here.

Those of you who mention BioJobBlog or BioCrowd when registering for the conference will receive a $200 registration discount.

See you at the meeting!!!!!!!

Until next time…

Good Luck and Good Job Hunting!!!!!!!

 

Why Transforming FDA Makes Sense

Posted in BioBusiness

During the Bush Administration I, along with many others, was a harsh critic of the US Food and Drug Administration (FDA). The criticisms that I levied against the agency were mainly based on its inability to adequately maintain the safety of the American drug and food supply and Bush’s repeated attempts to politicize the organization and render it useless. That said, it is amazing how much has and will change at the agency during the Obama Administration. To wit, Margaret Hamburg, the current FDA Commissioner yesterday announced plans that would dramatically transform the agency and largely change the way it does business.

In an unusually rare special report entitled “Pathway to Global Product Safety and Quality” Hamburg points out the monitoring problems currently facing the agency and proposes a four-point plan on how to fix them. To understand the importance of this document it is necessary to point out some little know facts about the American food and drug supply.

First, almost two-thirds of all fruits and vegetables and nearly 75 percent of all seafood consumed by Americans is imported. This year the number of these types of food shipments is expected to grow to 24 million through 300 or more ports. A little as a decade ago, the agency was responsible for overseeing and policing six million shipments annually. Second, it is estimated that over 80 percent of the active pharmaceutical ingredients (APIs) found in approved drugs are made in manufacturing plants found mainly in China, India and Latin America. Because of funding and “manpower” shortages, most of these API manufacturing facilities are rarely inspected for regulatory compliance. According to the report, many kinds of antibiotics, oncology drug and other medications are no longer produced in the US or in many cases anywhere in the Western world. Finally, roughly 50 percent of all approved medical devices sold in the US are made in foreign production facilities.

In 2008, government officials determined that the agency would need approximately 13 years to inspect all foreign drug manufacturing plants, 27 years to check every foreign medical device production facility and a whopping 1,900 years to check every foreign food production plant! This is because FDA has only several hundred inspectors who are empowered to perform these inspections. Consequently, only a fraction of the food and APIs imported to the US are inspected. For example, less than one pound in a million of imported seafood gets as much as a “visual inspection” to determine whether or not it is fit for American consumption. This led the report’s authors to contend that “the safety of America’s food and medical products remain under serious threat.”

Yet, despite this ongoing threat, Republican lawmakers last week voted to cut the agency’s budget rather than increase it to perform the necessary number of food and drug inspections. Further, the same lawmakers oppose any corporate or consumer fees, whether voluntary or forced, to help to underwrite the inspections calling them an unacceptable tax. This has forced the agency to enlist the help of regulators in other nations to create a global coalition or network to perform the required inspections to insure the regulatory compliance and safety of foods, drugs and devices imported into the US. While the FDA has limited cooperation agreements with regulators in Europe and other Western countries, it just recently stationed its own inspectors in emerging markets like China, India and Central America. In theory this should work. However, in the past, some of the governments of these countries have refused to fully cooperation with FDA. Further, and perhaps more problematic, is that regulatory agencies in some other countries are largely corrupt or nonexistent. Finally, some outspoken former FDA employees and critics contend that improvements in the communication between FDA in Washington and its field offices in US states may be necessary before the agency can effectively enlist the cooperation of foreign regulators.

There is no doubt that contaminated foods, counterfeit medical devices and tainted drugs are increasingly finding their way into the US. It is FDA’s legislated responsibility to insure that all foods and drugs sold in the US are safe and effective for all Americans. Republican lawmaker’s refusal to increase FDA’s budget to allow the agency to fulfill its mandate is unconscionable and indefensible. The safety and health of all Americans is critically important for the well being of the nation and ought to take precedent over budget shortfalls and a looming US trade deficit.

Until next time…

Good Luck and Good Job Hunting!!!!!!

 

Medical Device Giant Medtronic Will Shed 2,000 Jobs

Posted in BioJobBuzz

Medtronic one of the world’s largest medical devices manufacturer earlier this week announced that it will cut its workforce by 5 percent which translates into 1,500 to 2,000 fewer jobs. Most of the cuts will come from the company’s struggling external heart defibrillators unit (Physio-Controls) which it would like to sell. Revenues from pacemakers and defibrillators, Medtronic’s largest selling products, fell 2 percent in the last quarter. 

In a statement, the Minneapolis-based Medtronics will cut 4 percent to 5 percent of its employees with voluntary programs, retirements and layoffs. 

Until next time…

Good Luck and Good Job Hunting!!!!!!!

 

Study Finds Pharma Wrongdoing on the Rise

Posted in BioBusiness

In a first-of-its-kind study, researchers at the Public Citizen’s Health Research Group tracked the civil and criminal financial penalties levied against the pharmaceutical industry for wrongdoing over the past 20 years. 

The main findings of the study revealed:

  1. Of the 165 settlements comprising $19.8 billion in penalties during this 20-year interval, 73 percent of the settlements (121) and 75 percent of the penalties ($14.8 billion) have occurred in just the past five years (2006-2010).
  2. Four companies (GlaxoSmithKline, Pfizer, Eli Lilly, and Schering-Plough) accounted for more than half (53 percent or $10.5 billion) of all financial penalties imposed over the past two decades. These leading violators were among the world’s largest pharmaceutical companies.
  3. The practice of illegal off-label promotion of pharmaceuticals has been responsible for the largest amount of financial penalties levied by the federal government over the past 20 years. This practice can be prosecuted as a criminal offense because of the potential for serious adverse health effects in patients from such activities.
  4. Deliberately overcharging state health programs, mainly Medicaid fraud, has been the most common violation against state governments and is responsible for the largest amount of financial penalties levied by these governments. This type of violation is also the main factor in the considerable increase in state settlements with pharmaceutical companies over time.
  5. Former pharmaceutical company employees and other “whistleblowers” have been instrumental in bringing to light the most egregious violations and have been responsible for initiating the largest number of federal settlements over the past 10 years. From 1991 through 2000, qui tam (whistleblower) cases made up only 9 percent of payouts to the government, but from 2001 through 2010, they comprised 67 percent of total payouts.

The companies, their missteps and the fines imposed are shown below:

The authors conclude:

"Over the past two decades, especially during the past 10 years, there has been a marked increase in both the number of government settlements with pharmaceutical companies and the size of the accompanying financial penalties. Given the relatively small size of current financial penalties when compared to the perpetrating companies’ profits, both increased financial penalties and appropriate criminal prosecution of company leadership may provide a more effective deterrent to unlawful behavior by the pharmaceutical industry."

Interestingly, about a month ago officials at the US Food and Drug Administration signaled that were willing to prosecute company executives to the fullest extent possible (including criminal prosecution) to reduce the incidence of fraud, off-label marketing and manufacturing violations that have become commonplace in the pharmaceutical industry in the past five years.

Until next time….

Good Luck and Good Job Hunting!!!!

BioJobs: So You Think You Want to Be a Regulatory Affairs Professional?

Posted in BioJobBuzz

Regulatory affairs professionals (RAP) are by far some of the most important employees at pharmaceutical, biotechnology and medical devices companies. Without RAPs, the requisite regulatory documents would not be filed and new drugs and devices would not be approved for marketing and sale.

Unlike other life sciences disciplines, a career in regulatory affairs is highly industry- specific and rarely taught at most academic institutions. In other words, if you are considering a career in regulatory affairs, don’t expect to get the training that you need in a PhD or postdoctoral training program; you will have to get it elsewhere!

A recent report compiled by the Regulatory Affairs Professionals Society (RAPS) entitled the “2010 Scope of Practice & Compensation Report for the Regulatory Profession” highlights the growing value and importance of regulatory affairs personnel in the life science industry. The report was compiled from the results of a survey of over 3000 regulatory affairs employees in 55 different countries.

The results show regulatory professionals are taking on a wider range of responsibilities, including becoming increasingly involved in critical business functions. Despite the economic downturn since the previous survey in 2008, overall compensation continued on an upward trend, although it grew at a slightly slower pace. The report also points to the continuing globalization of the profession, increased involvement with multiple product types and 6% higher compensation for professionals with Regulatory Affairs Certification (RAC).

Other important findings included in RAPS’ report include:

  • US respondents with the RAC credential reported average total compensation that was 6% higher than their peers without the RAC. Forty-four percent of all survey respondents are RAC certified.
  • The percentage of RACs is especially high in Canada (54%) and the US (47.2%). A little more than 21% of European-based respondents reported having the RAC.
  • Overall, about 34% of respondents said they were involved in comparative effectiveness research and reimbursement, up from 23% in 2008.
  • Half of all senior-level respondents reported being involved in government affairs.
  • About 70% of respondents said their work is either global in nature or focused on multiple regions of the world.
  • More than 68% reported involvement with multiple product types, a 6.3% increase from 2008.
  • Overall, just 5.7% reported working with biosimilars, a product category that was added to the survey for the first time, but 22% of respondents from Asia and Latin America reported involvement with biosimilars.
  • Nearly all respondents have a university degree; many have advanced degrees. The percentage of respondents whose highest degree earned is a master’s is up to 37.5%, a 17.2% increase from 2008. The percentage of respondents with MBAs and postgraduate certificates also increased.
  • Respondents reported significant professional experience outside regulatory, an indication that many have transitioned into regulatory from another, related field. Most have educational backgrounds in life sciences, clinical sciences or engineering.

If this sounds like a career option for you, I highly recommend that you visit the RAPS website. If you already have a PhD, masters’ degree or even a bachelor’s degree, getting RAC certification will certainly increase the likelihood of landing a regulatory affairs job in the life sciences industry. One caveat: the RAPS courses are not inexpensive and may require a substantial amount of time in order to pass the RAC examination.

If the RAC route doesn’t seem realistic or reasonable, try getting an entry-level job with the US Food and Drug Administration. Being an ex-agency employee will guarantee employment in the life sciences industry until you retire!

Until next time….

Good Luck and Good Job Hunting!!!!!!!!!

 

Biotechnology and Related Health Sciences Jobs Rank Highest for College Graduates in 2010

Posted in BioJobBuzz

A recent study conducted by University of California San Diego Extension ranks careers in the health and life sciences fields at the top for recent college graduates. Sandy Bloom of GreatDegree.com recently wrote an article (see below) that provides insights and tips on how recent college graduate may be able to “snag” one of these up and coming hot jobs!

Hot Careers for College Graduates in 2010

By Sandy Bloom

For college graduates, landing a first job can be daunting, especially in hard economic times. But a recent report released by UC San Diego Extension, “Hot Careers for College Graduates in 2010,” shows that for certain career paths, finding a job may be easier than you think.

Nearly half of the top careers listed in the study stem from the health and bio fields, including the areas of health information technology and health law.

After earning a health degree or online biology degree, you can soon be working in one of these hot jobs, too.  Here’s how:

Health Information Technology

The report ranks careers in health information technology at the top because physicians and hospitals must update their medical records systems to be completely electronic in the coming years. Health information technicians are responsible for organizing these medical records, ensuring the records are accurate and complete, and updating the patients’ files electronically. According to the Department of Labor, employment of medical records and health information technicians is expected to increase by 20 percent over the next eight years.

Those looking to work in this high-demand profession should earn an associate’s degree with coursework in health information. Most employers prefer hiring credentialed medical record and health information technicians who have passed a credentialing exam. Experienced medical records and health information technicians advance their careers by earning bachelor’s or master’s degrees in biology, math, chemistry, health, and computer science.

Clinical Trials Design and Management For Oncology

The second ranked “hottest” career is clinical trial managers, specifically for cancer drugs. According to the report, “as the population ages, diseases are becoming more prevalent” and cures for those diseases are in demand. Clinical trial managers must oversee researchers who dedicate years to researching and testing before getting experimental drugs approved and brought to the market.

To become a clinical trial manager, you should earn a bachelor’s degree in chemistry, biology, or another life science. Then, receive a post-baccalaureate certificate to be certified by the Academy of Clinical Research Professions. Those working toward this in-demand career should partake in observation study courses or internships to observe a clinical trial in progress. Lastly, sign up to take online computer science courses to become familiar with Clinical Trial Management Systems.

Geriatric Health Care

According to last census in 2000, some 14 million seniors ages 65 and older report some level of disability that needs extra care. That means there is a huge demand for elder care professionals such as nurses, doctors, and nursing care professionals specializing in geriatric health care. In addition, because of the increasing incidence of mental illness among the aging, there is also a high demand for psychology professionals trained to treat older patients.

Training to be a nurse, a doctor, or psychiatrist or psychologist requires a bachelor’s degree in science as well as completion of board exams and residencies.

Occupational Health and Safety

Occupational Health and Safety Specialists (OHSS) analyze work environments to prevent injury by studying trends or patterns of injury and illness. They then suggest policy changes and develop and implement programs to improve conditions or practices that are dangerous. Environmental health and safety officers, ergonomists, health physicists, and industrial hygienists all perform this type of work.

To become an occupational health and safety specialist, you should earn a bachelor’s degree in a science or engineering discipline or a Master’s degree in science or in public health. All specialists must be trained on the law and inspection procedures through classroom and on-the-job training.

Other careers to consider include synthetic biology, regenerative medicine, stem cell research and medical devices including molecular diagnostics.

Hat tip to GreatDegree.com

Until next time…

Good Luck and Good Job Hunting!!!!!!!