CMC Biologics Specialist
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
- Type de paie Salaire
- Île-du-Prince-Édouard, Canada
- Nouvelle-Écosse, Canada