RA CMC Director for CGT - Exciting Pipeline for both Gene Therapy and CAR-T treatments

Reference: SII533

Expiry Date: 26-04-2023

Categories Biotech, Regulatory Affairs

Salary: On Application

Job Type: Full Time

Middlesex County
United States
Remote Working

Apply for position

Job Description

Adv Talent Partners are excited to present a brand-new RA CMC Director role with huge potential, where you can be involved in all stages of  development from P1 to BLA – so a full project lifecycle role!

Our client is an exciting organisation because of their Data, Leadership Team and Technology Platform and this will be the  right company for you, if you are looking for the opportunity to work on new meds in early dev with a unique technology of genome editing, which allows for the speedy approval of a new class of therapies for patients with genetic and oncological diseases.

The current data on their pipeline programs in Phases 1 and 2 is very exciting and the role offers the opportunity to work on both Gene Therapy and CAR-T treatments.  The Head of Regulatory CMC is very passionate and committed, and highly experienced  in  CGT projects, for both for early and late-stage development projects, and he will mentor and support you in decision making and strategic input & leadership, ensuring you have a clear pathway for progression.

Stability is key in the CGT sector, and our has a client market capital of over 3 billion USD and has grown rapidly to almost 500 people. They are also consistently rewarded for having the best working environment and company culture in the CGT sector and are universally seen as one of the rising stars to watch in Cell and Gene.

The teams on all levels consist of pro-active professionals dedicated to their field of work, who are all very welcoming of inspired and innovative newcomers and the culture is focused on positive collaboration, and enjoying the challenge of being first to market.

By joining,

  • You will become the RA CMC Lead for your assigned NMEs which are all cutting edge and lead your own sub-team under the support and guidance of the line manager to BLA
  • You will get to drive adherence to CMC regulatory guidelines relevant for the development of both gene therapy and CAR-T products
  • You will lead the development of manufacturing strategies for the company’s therapeutics, including assessing proposed manufacturing process changes, providing strategic regulatory guidance, and participating in the development of regulatory processes and standards
  • You will be working under an exciting and highly regarded leadership team, with the knowledge and experience in  how to bring assets through the pipeline to registration, consisting of pioneering executives known for their breakthrough approach in Cell and Gene Medicines and Genome editing
  • You will receive a strong total package including RSU’s, Stock Options, yearly bonus and competitive basic salary; the benefits and holiday allowance are graded well and could be described as generous
  • The company is headquartered in Massachusetts, but the role is fully remote, to provide you with a quality work-life balance.

You will need in have RA CMC experience for IND’s in either CGT or for Biological projects and  have led and/or supported a BLA.


To Apply!

To apply for this role, please contact me, Theo Moore on US 587 216 9302 or my colleague Ivan Nash on US 908 378 8980 or press the red “Apply for position” button or send a full CV to Ivan.Nash@AdvTalent.com and we will reply by return. We will support you throughout the interview and on-boarding experience.

GDPR & Data Protection: Your information is safeguarded for GDPR, and you will have the right to edit, amend or delete and ’’be forgotten’’ at any time after your initial registration.