Process Development Lead *** rAAVs / Viral Vector NBEs

Employer
Advanced S&S (Medical / Clinical)
Location
Remote then Mainland Europe Post-Covid
Salary
On Application
Closing date
26 Sep 2020

View more

Discipline
Manufacturing, Engineering, Process, R & D , Biotechnology, Genetics and Genomics
Hours
Full Time
Contract Type
Permanent
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Adeno Associated Viral Vector (rAAVs) Process Development Lead

Note: This role is located in Belgium. Post-Covid a full and generous relocation package is available. Until then home working is offered as standard!

Note: My client has committed to do Digital Hiring and Digital On-Boarding process in place to allow a smooth transition during the outbreak. During the next period, new hires will be allowed to work from home, until such a time occurs when normal working returns. At this point, if you are not residing in Belgium the role will require you to relocate to Brussels, which is fully paid for by my client, but until this time, this and many other roles are using remote working.

This role can be a Director or Associate Director grade, dependent upon your experience and capabilities!

About the Client

This role is with a biotechnology pharmaceutical company with global impact where people are encouraged and developed:-

  • Has many successful marketed products and more than 15 years of experience since they were early adopters of mAb’s, now they intend to expand the portfolio to include (rAAVs).
  • They have invested already in VVs and expect this discovery and research pipeline to move soon to the clinical phases, this is where this role is pivotal!
  • My client is growing by around 15-20% year-on-year, and has invested steadily in R&D by >21% of T/O over last 5 years for a number of therapies areas including rare diseases, and wider disease targets.
  • The company was to bring in more advanced therapies into the portfolio, and have an established licensing and alliances team to establish future research collaborations.

About the role:

My client is looking for a process development leader / senior scientist background with PhD or Masters (MEng, MBio) and 5-8 years of industrialization experience (could be less with Post Docs) in process development for biotechnology products, and 2-3 years specifically on Adeno Associated or Lentiviral development, including process characterization, scale-up for Viral Vector NBEs. The candidate will be the leader of new research and improvement projects and will be part of the core team bringing these molecules into and through IMP development, P3 scale up and eventual commercial manufacture.

You will consider this role if you have previous experience in:

  • Expertise in co-developing / leading new manufacturing processes completed for mfg campaigns on Viral Vectors (could be from a CDMO/CMO, or for a Biotech)
  • You will be someone who designed experiments not just ran them!
  • PD for Phase 1/2 IMPs on VVs and scale-up, however for the P3 scale up, if not on a VV then at least one or more biological(s)
  • Strong capabilities in PD for upstream, mid and downstream engineering including characterization as well as support for risk, TQPP and CQA, etc.
  • Good understanding of FDA and EMA requirements for CMC packages for ATMPs 
  • Ability to work in close knit teams internally with analytics, quality, project management, sterile packaging, clinical supply, and with external CDMOs MSAT teams.

This role is fundamental to execute process development programs to bring for clinical study rAAVs materials and support the regulatory fillings related to them. You will be part of a core team which evaluates technology investments, to support multiple VV NBEs in the project pipeline.

Package & Benefits

This role is based in Brussels, Belgium and comes with full relocation, including disturbance allowances, temporary high-quality apartment, schooling if needed as well as a tax reduction package (for non-Belgium Nationals). The role comes with a car, bonus and stock plan, and there is ample opportunity to grow in this organization. During the Covid outbreak, you will work from home in your country of origin until travel restrictions are lifted!
 

To Apply!

To learn more and apply for this role, please send your CV with a covering note to cv@advtalent.com. You can also contact Javier Monfort or Matt Greig on +44 (0)207 801 3385 or +44 (0)207 801 3386 for an initial discussion about the role and other projects.

About Advanced Search & Our Network

Advanced Search, has a network of affiliated companies including ADV Regulatory, and ADV Talent Partners. Together, we are specialists in Regulatory Affairs and Life Sciences recruitment especially around mAbs and biologicals for roles in R&D and Commercialization and have been established and hiring in this area since 2005.

Our team know our subject matter areas and our mission is to help you grow your career each and every step of the way. We have helped many of today's leading companies develop strong regulatory sciences functions and are known for hiring complimentary teams that work well with each other, at owner-contributor, strategy leading and people management levels.

We provide a high level of service because we believe this matters.

Contact us today to see how we can help you, make that next career move on

+44 (0)20 7801 3380

All applications are kept in confidence and we invite applications from all members of the Academic, Research & Development based bio-/pharmaceutical community.

Advanced Regulatory is a new recruitment organisation. Our consultants are industry known and highly experienced in Regulatory Affairs recruitment. We have assembled a team with competencies in databased contingency recruitment, Search & Selection as well as Creative & Campaign management. Our specialism is Regulatory Affairs. We know that successful submissions are underpinned not by one but many people, all working in cohesion. Whether you require a new career position or a new recruit at junior, mid or senior level, we would like to assist you. Our remit is to provide Regulatory Affairs professionals at all levels to pharmaceutical, regulatory consulting, biopharmaceutical and clinical research organisations.

Contact Us
  • Suite 8, Penhurst House
  • 352-356 Battersea Park Road
  • SW11 3BY
  • GB
  • +44 (0)20 7801 3388
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