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CMC Technical Integrator



Introductie

Do you have extensive analytical development experience in the pharmaceutical industry and do you have excellent project management skills? Then this position might be interesting for you! As a CMC Technical Integrator you will ensure the technical representation of the line organization of the Analytical Development Department in CMC (Chemistry, Manufacturing & Controls) project teams.

Het bedrijf / The company

Pharmaceutical company specialized in the development of vaccines. You will represent the Analytical Development Department on the CMC team.



De functie / The role

Do you have extensive analytical development experience in the pharmaceutical industry and do you have excellent project management skills? Then this position might be interesting for you! As a CMC Technical Integrator you will ensure the technical representation of the line organization of the Analytical Development Department in CMC (Chemistry, Manufacturing & Controls) project teams.


As a CMC Technical Integrator you will ensure the technical representation of the line organization in CMC project teams

  • You will coordinate the project deliverables in close collaboration with the CMC Team Lead and functional line management.
  • You maximize the generation and use of knowledge to not only support project objectives but also grow departmental functional expertise. (re-useable knowhow)
  • Responsible for functional budget alignment
  • You will lead a functional sub-team containing other functional reps and Subject Matter Experts
    (SME) and are responsible for the planning and executing of functional project deliverables in close collaboration with the line to the desired cost and quality level
  • Responsible for successful functional process technology transfer to the plant/CMO including
    process-fit-to-plant activities


Het profiel / Your profile

For the position of a CMC Technical Integrator we are looking for an enthusiastic and communicative candidate.

  • 8+ years pharmaceutical industry experience preferably in a biopharmaceutical drug development environment and/or manufacturing environment
  • Project management experience (2-3 yrs)
  • GMP and regulatory process experience is required
  • Experience in Analytical Development and in particular in analytical method development and validation, interaction with
    regulatory agencies (IND/IMPD, MAA/BLA, briefing documents, etc) and ICH
    stability studies
  • Knowledge of other CMC activities (Drug substance/Drug product)
  • Ability to lead multidisciplinary teams of professionals and foster team productivity in a matrix environment
  • Proven organizational sensitivity and conflict resolution and planning skills


Het aanbod / The offer

  • Secondment via Checkmark Labrecruitment for 1 year. Longer term anticipated
  • Salary indication from €4500,- based on fulltime
  • Fulltime position (40 hours/week), 32 hours discussable
  • Ability to work on site at least 3 days oer week


Reactie / Reaction

Neem voor meer informatie contact op met Jurjen Wilschut: 088 00 211 22 // 06 3024 7453

Vacaturenummer: 6676




Solliciteer hier
Indien solliciteer hier u verwijst naar een ongeldig webadres, is de vacature (hoogstwaarschijnlijk) inmiddels vervuld. Attendeer FMF hierop

Uw referentie aan www.fmfvacatures.nl wordt gewaardeerd.
Your referral to www.fmfvacatures.nl is appreciated.


Gegevens

Werkgever:
CheckMark Labrecruitment
Vacaturesteller:
CheckMark Labrecruitment
Standplaats:
Leiden

Geplaatst op FMF: 21 juli 2020

Branche: Farma & Biotech, Healthcare
Functie: R&D, QC / Laboratory, Management
Opleidingsniveau: HBO / BSc
Werkervaring: 2-5 jaar, 5-10 jaar