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CMC Leader 

Location: Amsterdam
Start: ASAP (aim on May/June)

Our client is dedicated to bring innovative therapies or unmet medical needs to patients. In doing so each function in the company is directly or indirectly responsible for the lives of patients. This responsibility should be part of our day-to-day working life by (i) living up to high quality standards and (ii) recognizing the sense of urgency in areas of high medical need.

 

Purpose of the role

The purpose of the role is to lead all drug development (drug substance and drug product) activities required for a gene therapy program to transition to first in human clinical phase. You will be guiding a multidisciplinary team of experts through initial phases of development of regulatory approval – also called CMC or “Chemistry, Manufacturing and Controls”. In this role you will be responsible for defining strategy and timeliness for all CMC development activities of a specific gene therapy program. You will be ultimately accountable for delivering of investigational drug and associated development documentation needed for regulatory filings.

Key result areas (major duties, accountabilities and responsibilities) 

  • Developing strategy and timeliness for all CMC development activities
  • Guiding and coordinating all in house and external CMC development activities
  • Providing scientific expertise and leadership to the CMC team(s)
  • Taking active part in preparation of briefing documents and responses to regulatory quarries
  • Taking active part in teleconferences and face -to- face meeting with regulatory authorities as needed
  • Establishing a CMC development record tracking system
  • Interacting with the research groups to provide insight and optimize transition of research programs to development activities
  • Establishing good communication and collaborative relationship with cross-functional colleagues
  • Aiding technology transfer for both process and analytics
  • Developing junior team members by providing technical guidance and support

 

Qualifications & Skills

  • Holds a PhD (Bio-sciences e.g. biotechnology, virology, biochemistry, molecular biology) with at least 10 years of relevant experience. Alternatively, in certain circumstances, holds MSc with 15+ years of relevant work experience
  • Possesses extensive experience (+7 years) in development of ATMPs
  • Understands regulatory framework regarding ATMPs (EP, USP, ICH, EMA/FDA guidelines)
  • Proven track record of involvement in successful IMPD/IND filings
  • Possesses experience in process or analytical development of ATMPs
  • Experienced in multiple areas from the following: insect cells/BEVS bioprocessing, rAAV, gene therapy is an advantage
  • Outstanding scientific writing skills
  • Fluent in English.


Core competencies

  • Delivery oriented with a strong ability to lead
  • Autonomous thinker with a sense of urgency
  • High level of ownership of the assigned programs
  • Leader team player with an attitude to mentor others
  • Flexible to act in a highly dynamic and demanding environment
  • Proven ability to work interdisciplinary
  • Able to build and lead highly performing teams
Neem contact op

SIRE® LIFE SCIENCES B.V.

Staten Bolwerk 1
2011 MK Haarlem
The Netherlands
+31 (0) 20 658 9800

SIRE® STAFFING SOLUTIONS B.V.

Keizersgracht 440A
1016 GD Amsterdam
The Netherlands
+31 (0) 20 658 9804