Regulatory CMC Director *** US Remote or Northbrook, IL ** Take a new mAb & 2 NMEs through Dev. and Lifecycle ***

Reference: KLM514CR

Expiry Date: 01-11-2022

Categories Biotech, Manufacturing / Production, Regulatory Affairs

Salary: On Application

Job Type: Full Time

Cook County
Съединени щати
Remote Working

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Job Description

My client is different, in a good way, they have a small but polished pipeline of NMEs and have recently acquired a company with a mAb development platform, and your role will be as the GRL for CMC RA, in a company which is smaller, but more stable than most (they have been in existence for 70 years plus).

You will have experience in BLA or sBLA submissions preparation, ideally starting with the RA CMC strategy and building out to the full CMC package; alternatively, you will have RA CMC lifecycle management and want to gain more development experience – my client can offer both!

About My Client:

  • Smaller pharma with many existing marketed products (small molecules) now expanding their mAb platform.
  • The company is consensus driven not hierarchy driven.
  • The team and the management are inclusive, but as mAbs are now a new modality for them, they want someone who can, “teach a man to fish” – you will help stakeholders and peers, as well as other teams understand how to develop and market from a technical CMC perspective, mAbs.
  • The company offers 8 weeks off a year as holiday so they really value work-life balance and are willing to show it in real terms.
  • The company is offering remote or they will relocate you at their cost to WA or IL, as you choose, the company does not have a preference, remote is just as good - it is your choice!
  • The company offers a decent salary plus bonus and LTIs in an environment where people are valued!
  • They have been named as Employer of the Year in employee surveys and really do look after their people!

Your skills:

  • You will have experience in leading CMC regulatory planning and submissions from a strategy and HA liaison point of view
  • Experience with the US is a must, any experience with International countries like China or Japan is useful and attractive
  • You will be collegiate, like working in niftier companies with low politics and objective focused decision making (can-do attitude)
  • You will have a good education but want to learn and develop, so you can grow into a larger role
  • You will like working with other people showing them what you know and bringing more expertise to the group


To Apply!

To apply for this role, please contact me Theo Moore on US 908 348 6714 or press the red “Apply for position” button. I will support you throughout the interview and on-boarding process!

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