Vice President CMC Regulatory mAbs ** USA / US Remote or Europe (Various) ** Build out a new team to support mAbs - West Coast

Reference: KLM2207A

Expiry Date: 18-10-2022

Categories Biotech, Manufacturing / Production, Regulatory Affairs

Salary: On Application

Job Type: Full Time

San Francisco County
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Job Description

The Role

My client has retained me to identify and assess as well as successfully hire a capable, motivated VP of Regulatory CMC.  You will have vision of what you can build in terms of the Regs CMC platform / MSAT / CMC overlay and will inherit a team of several FTEs based world-wide.

This role is not for someone who wants to sit at home, and although remote is offered, there is a fair amount of travelling to do to build the stakeholder relationships, work through the existing pipeline of both small and large molecules, and redevelop the capabilities, systems and processes, resources and filing plans for their lead mAb molecules and lead NCE filings: with you brining new expertise in the area of mAbs to supplement their existing capabilities in small molecule IMP development and Marketed Products portfolio.

About My Client

This is not a start-up, the company has existed for more than 50 years, and has an existing portfolio with presence in more than 50 markets, but it is still a medium-sized R&D based bio-/pharma, with around 5000 employees. You will support DS and DP, manufacturing and supply, as well as QA and the technical teams deliver a new first in class molecule as the transforming agent for the company to deliver multiple mAb therapeutics word-wide. The company has several programs in mid to late phase to run after this.

The organization invests a healthy 20 plus percentage wise R&D budget yearly, has a stable stock listing, and has little debt. The leadership is credible, supportive and experienced, coming mostly from big pharma’s and now wanting to have a less political, more impactful type position, this idea will also appeal to you.

Package & Bens

PTO, holidays, and company culture are (way) better than the norm, and if I had to say how their culture looks to me, they are incredibly respectful and err to non-hierarchical with strong emphasis on consensual decision-making and collaborative work-streaming. You will have strong visibility in this role.

Package and benefits are within market norms, and the company will consider buying out stock plans and bonus losses for the right individual.


To Apply!

To apply for this role, please contact me, in the first instance, Matt Greig, on US +1-908.332.9157 or if you are in Europe, UK Direct +44.2078013386 – I accept calls until 4 pm Eastern time daily, and also Saturday and Sunday AMs, or press the red “Apply for position” button. I will support you throughout the interview and on-boarding process!

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