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CMC Biologics Specialist

Nova Scotia, Canada; Prince Edward Island, Canada; Virtual Req #186
Monday, June 22, 2020
BioVectra Inc. is a leading bio-science business in Prince Edward Island and Nova Scotia, focused on contract manufacturing and product development of active pharmaceutical ingredients, pharmaceutical intermediates, and bioreagents.

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

We thank all applicants for their interest but wish to advise that only those selected for an interview will be contacted.

Other details

  • Pay Type Salary
  • Nova Scotia, Canada
  • Prince Edward Island, Canada
  • Virtual