Associate Director - CMC

Location Leiden
Discipline: Biotechnology, Pharmaceutical
Job type: Temporary/Freelance
Contact name: Gemma Dozy

Contact email: g.dozy@panda-int.com
Job ref: 12202
Published: 3 days ago

One of our leading Biotech clients has an opening for an Associate Director – CMC / Sr. Technical Integrator in Leiden. This position starts with a 7 month contract, however extension is expected.

Responsibilities

  1. Contributes to dossier strategy/complex product development plan creation at a compound level and to limited degree at a functional level
  2. Communicates and executes dossier strategy/product development plan with high level of autonomy and accountability
  3. Direct responsibility for project budgets
  4. Leads and supervises dossier authoring activities for early and late stage projects with limited or no guidance from manager 
  5. Identifies business improvement areas and leads implementation of improvements
  6. Drives structured improvements of functional processes (quality, cost, time, asset utilization) in line with business or operational strategy.
  7. With limited or no guidance, interfaces directly with CMC/Tech team members, Regulatory, JSC, external service providers and internal VPAD customers
  8. Interfaces with internal and external functional stakeholders
  9. Influences or persuades others to accept new ideas, approaches or concepts or gains alignment on divergent issues with limited guidance and occasionally at multiple levels of management
  10. Combines technical expertise with management skills. May select and manage external consultants
  11. Manages several complex projects with potentially accelerated priority OR leads complex Phase 3 clinical programs
  12. Challenges status quo and identifies innovative approaches to improve products/processes
  13. Scope is a mix of incremental and transformational innovation, within own dept/team and function
  14. Independently resolves isolated cross-functional issues
  15. Appropriately identifies and manages key stakeholders and escalates when needed to obtain senior management support. With limited guidance, takes day-to-day decisions on operational priorities for his/her team, and allocates resources accordingly
  16. Works independently on a day to day basis, checks in with supervisor as needed for identified high-priority issues
  17.  Manages functional or project teams with up to 15 members
  18. Strong input on promotions, recruitment strategy and team structure
  19. Acts as a mentor to one or more individuals
  20. May coach project teams

 

Education & Experience

  • PhD with Post-doc experience with 6+ years relevant experience
  • OR University degree with 8+ years relevant experience
  • OR Equivalent by experience
  • +5 years experience with CMC

 

Start Date

  • ASAP

 

Project Duration

 

  • 7 months (extension optional)

 

Interested?

 

If you are interested in the above description, apply with your CV

PS: Did you also know that we offer an attractive referral scheme?

For more information please contact Gemma Dozy on +31 (0)20 20 44 502