Head of CMC (full time)

Head of CMC (full time)

Full time @Hybridize Therapeutics in Life Sciences
  • Zuid-Holland, Netherlands The, Rijnsburgerweg 10, Leiden, the Netherlands, 2333AA View on Map
  • Post Date : January 13, 2022
  • Apply Before : February 7, 2022
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Job Detail

  • Job Type Full-time
  • Experience 8 Years +
  • Industry Life Science
  • Qualifications Master’s Degree

Job Description

About us 

“Do you want to join us on our journey to change the lives of millions of kidney patients?”

 Kidney disease is a major problem. Worldwide 1:10 people are suffering from chronic kidney disease (CKD). A progressive clinical unmet need that results in kidney failure with a growing number of people needing to rely on dialysis to survive. It is therefore the 8th leading cause of death in Western society.

We are Hybridize Therapeutics. We are a growing Biotech start-up on the forefront of developing innovative RNA-based therapies for kidney patients. We are driven to make a difference and prevent people from ending up with the severe consequences of kidney failure. We believe RNA therapeutics are the perfect modality to treat kidney disease. Our deep expertise & network in the field of RNA therapeutics will help us be pioneers in this field. Will you join us on our mission?

We are looking for extraordinary people who:

  • Are inspired by our mission: to prevent people ending up with kidney failure
  • Love to be creative, but are also critical thinkers, real pioneers
  • Want to work in a fast paced, start-up environment with a strong focus on R&D
  • Are looking for a tight and close team, who also love an occasional drink or dinner

Vacancy

Position: Head of CMC (full time, partly remote)

Role description

The Head of CMC enables the production of RNA-based investigational products for kidney diseases and the writing of the associated IMPD/IND. We are looking for a hands-on person that likes to work in a start-up environment. The role involves the from scratch development of a supplier network and strategy for delivery of Hybridize’s first investigational product.

We are looking for a Head of CMC with a broad background in chemistry, who can, alongside CMC, think along with the research team on rational design and delivery of RNA therapeutics for kidney diseases.

 What we offer you

  • A fun place to work!
  • A competitive salary and benefits package
  • Flexible working arrangements
  • Standing at the frontline of developing RNA-based therapies for kidney patients
  • An opportunity to hone your skill set in a start-up environment
  • Team-focused dynamics
  • Social events

Key responsibilities

  • Development of CMC strategies and implementation plans, in close partnership with both internal and external resources to achieve Hybridize’s strategic and tactical goals
  • Delivery of IMPs for clinical trials.
  • Delivery of IMPD/Module 3, in line with clinical/regulatory objectives.
  • Work with own network and other internal and external resources to engage and select suppliers.
  • Is responsible for representing the company with regulatory agencies, addressing the CMC/Quality aspects of Hybridize’s development programs.
  • Enable the production of RNA for research purposes.
  • Contribute to rational design of RNA for kidney diseases.
  • Contribute to the preparation of abstracts, presentations and manuscripts.
  • Contribute to the further development and maturation of Hybridize Therapeutics.

 Your experience / qualifications

  • MSc degree (preferably Ph.D in organic chemistry or biochemistry)
  • >10 years of experience in pharma/biotech environment, preferably including startup experience
  • Familiar with current GxP and CMC guidelines
  • Highly skilled in vendor management and communication
  • Flexible, enjoys constantly changing environment
  • Works hands-on and independent

If you would like to know more about Hybridize Therapeutics, this position and our offer, feel free to contact us via info@hybridizetherapeutics.com. Or have a look at our website: www.hybridizetherapeutics.com.

Attached Files

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