The CMC Essentials
"I recently joined this team - developing a really amazing cure for Cancer... Sometimes it's hard for me to follow all the jargon and acronyms, and I can't stop them and ask for explanations all the time... I wish I could speak this language more fluently!"
"I need to hire new team members in junior positions, but I need them to know the industry basics beforehand because I have very limited time available to teach them..."
- R&D Director at a Biotech startup
"I recently graduated and go to job interviews where I politely nod at the recruiter telling me what they do, but I really have no idea what all these things mean!"
-Recent Biotech graduate
"I am almost finishing my PhD, and considering if to pursue a post-doc and shoot for an Academic career or do the jump into the industry... But not sure what is waiting for me out there..."
-PhD student in the life-sciences
Do any of these resonate with you?
Hope I can be of help!
What is CMC?
CMC is the umbrella term we use in the industry to describe all the aspects of making our pharmaceutical products, in pharmaceutical grade and in compliance with Good Manufacturing Practices (GMP) and other regulations.
CMC Essential concepts - from start to end, no prior professional knowledge is assumed.
We will understand nuances that pertain different kinds of drugs and therapies, like biologicals and cell therapies.
We will discuss the ways pharmaceutical products are manufactured- either in-house or at contract manufacturing organizations (CMOs), and touch the key aspects in science and technology, as well as the daily management of manufacturing development: selection of CMOs, process development, selection and control of raw materials, cell banks and more. We will also briefly introduce the concepts of process validation.
We will understand the concept of quality and controls- from analytical methods, in-process controls and validation, all the way to quality by design. We will imagine where the field is going with some thoughts about Pharma 4.0 and an overview of the current industry thinking on Machine learning, AI, blockchain and more.
We will learn of the regulatory framework that outlines the work in CMC- from written words in laws and guidelines to the less-formal expectations and industry-standards, and we will see how the CMC requirements evolve over the course of pharmaceutical development.
Here is a quick introduction to the course content:
Who is this for?
This is an entry-level course, meaning no prior professional experience in CMC assumed.
Young professionals in CMC-related departments, such as Manufacturing, Quality, QC and Regulatory - in need of a comprehensive orientation to the Pharma-CMC world
Experienced CMC professionals, looking for additional perspectives to pass on to their teams
Students in Science and Engineering, approaching the end of their studies and considering a career in Pharma
Non-CMC professionals within Drug Developing companies (e.g., R&D, Medical experts, finance, technicians and management)
Professionals from other fields, interested in joining in the Pharmaceutical Development world, and are interested in a wide-overview of the Manufacturing aspect.
Is this only for people with life-science / chemistry background?
Not at all! The Pharma field is stepping quickly into the world of Pharma 4.0 which will harness the power of Machine learning, AI, blockchain and more. So the as it evolves there is a huge demand for Computer and Data scientists, and Engineers of diverse backgrounds.
Should I get a PhD before going to the industry?
This is a big topic- but in short- not a must. There are many career paths to follow, many of which require professional experience just as much as scientific expertise. If you are not in love with the scientific life, I encourage you to consider stepping out of the academia and start your career, wherever you are. I did this transition and survived to tell!
The course runs twice a year- subscribe below to get notified.
Can't wait? Recording of previous cohort is available to watch on-demand- register today and watch it, until we meet live.
The course comprises of 10 sessions, 1.5 hours each (~15 hours total).
Certificate of completion will be awarded to students who fulfilled the course requirements
Students get fulll access to course contents and to the Tree of Knowledge for 6-months (for extended access, please E-mail us