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Project Manager, CMC

Xenon Pharmaceuticals Inc


Location:
Burnaby, British Columbia V5G 4W8
Date:
09/06/2017
2017-09-062017-10-06
Job Type:
Employee
Job Status:
Full Time
Xenon Pharmaceuticals Inc
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Job Details

Xenon is a clinical stage biopharmaceutical company focused on developing innovative therapeutics to improve the lives of patients with neurological disorders. Building upon our extensive knowledge of human genetics and diseases caused by mutations in ion channels, known as channelopathies, we are advancing – both independently and with our pharmaceutical collaborators – a novel product pipeline of ion channel modulators to address therapeutic areas of high unmet medical need, such as pain and epilepsy.

We are seeking a Project Manager to join our CMC team.  This is a permanent full-time, office-based position at either of Xenon’s Burnaby or Boston offices.  The Project Manager will be required to work flexibly across a number of small molecule drug development programs with an emphasis on managing outsourced oral formulation development projects and cGMP drug product manufacturing campaigns.

RESPONSIBILITIES:

  • Manage, in whole and/or in part, multiple concurrent CMC-related projects at Xenon’s Contract Development and Manufacturing Organizations (CDMOs).  These projects may include one or more of:
  1. Pre-formulation and formulation development (for toxicology, clinical and/or commercial use)
  2. Manufacturing process development
  3. cGMP drug product manufacturing campaigns
  4. Analytical method development and validation
  5. ICH-compliant stability studies
  6. Clinical packaging, labeling and distribution
  • Assist with the drafting and quality control of the CMC (drug product) sections of regulatory submissions (e.g., INDs, CTAs, NDAs).
  • Perform CDMO contract-related activities (issuance of Requests for Proposal, negotiation, contract change control, performance monitioring, accepting deliverables, managing invoices and tracking accruals) within the scope of the Xenon’s contract management systems and policies.
  • Participate in CDMO audits and site visits as required.

Requirements

QUALIFICATIONS:

  • A university degree in organic/physical organic/analytical chemistry, pharmaceutics, pharmacy or pharmaceutical sciences.  Graduate degree strongly preferred.
  • A minimum of 5 years experience in the pharmaceutical industry, directly related to oral formulation development and/or cGMP manufacturing of small molecule oral drug products.
  • Good knowledge of modern oral formulation technologies, including those for solubility enhancement, controlled release and reducing stability risks.
  • Good knowledge of project management methodologies and practices as pertinent to outsourced R&D and manufacturing (including management of risk, scope, budget and schedule). Formal project management certification (e.g., PMP®) desirable.
  • Good knowledge and understanding of cGMP and of the US, Canadian and EU regulatory environments; previous experience with IND and CTA CMC submissions preferred.
  • Excellent written and oral communication skills, including the ability to communicate with scientific and non-scientific personnel.
  • Excellent attention to detail and commitment to providing accurate, high quality work.
  • Good organizational skills and the ability to manage multiple competing priorities.
  • Strong interpersonal and team skills to work both independently and collaboratively as part of a multidisciplinary team.

To apply for this position, please e-mail your resume and cover letter to careers@xenon-pharma.com and include “Project Manager, CMC” in the subject line. All attachments must be saved as one file and be named: “Your Full Name – Project Manager, CMC.” We thank all applicants for their interest; however, due to the volume of applicants, only those chosen for interview will be contacted.

Xenon is a clinical stage biopharmaceutical company focused on developing innovative therapeutics to improve the lives of patients with neurological disorders. Building upon our extensive knowledge of human genetics and diseases caused by mutations in ion channels, known as channelopathies, we are advancing – both independently and with our pharmaceutical collaborators – a novel product pipeline of ion channel modulators to address therapeutic areas of high unmet medical need, such as pain and epilepsy.

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