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CMC Biologics Specialist

Île-du-Prince-Édouard, Canada; Nouvelle-Écosse, Canada; Virtuel Numéro de demande186
22 juin 2020

BioVectra Inc. has an opening for a CMC Biologics Specialist. This is a permanent, full-time position with the successful candidate having the flexibility to be based out of Windsor NS, Charlottetown PE, or work remotely. 

 

The candidate will be responsible for:

 

  • Acting as the departmental representative accountable to Project Teams for all CMC aspects (strategic and operational) for assigned projects.
  • Defining the Product Definition and CMC Strategy documents with appropriate input from internal and external cross-functional team members.
  • Leading development of the CMC plan (activities and timelines) and ensure proper integration and alignment with the overall project plan.
  • Maintaining the CMC plan and timelines; monitor and control deliverables and scope.
  • Collaborating with functional representatives to anticipate and identify project risks and develop action and resolution plans
  • Preparing monthly status reports and internal team documents.
  • Interfacing with project governance bodies (internal and external) as required.
  • Coordinating with Operations to align efforts with clinical and commercial supply strategy.
  • Preparation of CMC sections for regulatory submissions.
  • Adhering to Quality Agreements with external parties
  • Maintaining a high level of knowledge in biological product manufacturing and characterization methodology through familiarity with scientific literature
  • Collaborating with other departments to develop biologic processes for clinical and commercial production.

 

The successful candidate for this position should have:

 

  • Master of Science degree in Chemical Engineering, Molecular Biology, Pharmaceutical Sciences or equivalent.
  • Ten years’ experience in the pharmaceutical or biotech industry with a strong knowledge of one or more areas of CMC development.
  • Experience with early-stage CMC development and clinical manufacturing of biologics.
  • Knowledge of all phases in the drug development process.
  • Experience with CMC development, from early through late stage into commercialization.
  • Demonstrated capability to efficiently manage multiple concurrent programs.
  • Demonstrated ability to work with cross-functional teams in a matrix environment.
  • Excellent communication skills, both oral and written.
  • Direct experience with CMC technical content for regulatory submissions an asset.

 

 

BioVectra offers a competitive salary and benefit package. Interested candidates are asked to apply by choosing the “Apply Now” button.

 

Closing Date July 6th 2020

Autres détails

  • Type de paie Salaire
  • Île-du-Prince-Édouard, Canada
  • Nouvelle-Écosse, Canada
  • Virtuel