Director, Formulation, CMC and Manufacturing

Location
Vancouver, British Columbia (CA)
Posted
May 11, 2021
Required Education
Doctorate/PHD/MD
Position Type
Full time

XYON Health Inc. (“XYON”) is a digital health company that plans to upend the men’s health and vitality market offering unique services and innovative consumer product offerings. XYON is at the leading edge of e-health and e-commerce having developed a high end brand and best-in-class topical formulation offerings. Our topical products are developed in partnership with leading formulation development and manufacturing firms world-wide. 

We are seeking a Director, Formulation, CMC and Manufacturing to join our team at an exciting stage.  You will be part of the founding team, joining seasoned experts and in a well-capitalized corporation. This is a permanent full-time, office or home office-based position.  The incumbent will be required to work flexibly across a number of development programs with an emphasis on sourcing, managing outsourced topical formulation development projects, outsourced cGMP drug product manufacturing and packaging campaigns and with contributions to intellectual property generation.

 

Responsibilities:

  • Manage, in whole and/or in part, concurrent CMC-related projects at XYON’s Contract Development and Manufacturing Organizations (CDMOs). These projects may include one or more of:

  • Pre-formulation and formulation development (for toxicology, clinical and/or commercial use)

  • Manufacturing process development

  • cGMP drug product manufacturing campaigns

  • Analytical method development and validation

  • ICH-compliant stability studies

  • Packaging, labeling and distribution

  • Perform CDMO contract-related activities (issuance of Requests for Proposal, negotiation, contract change control, performance monitoring, accepting deliverables, managing invoices and tracking accruals).

  • Draft the CMC (drug product) sections of any regulatory submissions (e.g. INDs, CTAs, NDAs).

  • Participate in CDMO audits and site visits as required.

  • Assist with formulation development activities with an emphasis on topical formulations.

  • Assist with managing intellectual property arising from formulation and manufacturing work.

  • Assist with the generation of dashboards for project reporting and development of summaries or slides for corporate presentations and board meetings.

 

Qualifications:

  • A Ph.D. degree (or equivalent) in organic/physical organic/analytical chemistry, pharmaceutics, pharmacy or pharmaceutical sciences.

  • A minimum of 10 years experience in the pharmaceutical industry, directly related to formulation development and/or cGMP manufacturing preferably in small molecule drug products.

  • Experience with topical drug product development is a major asset.

  • Strong track record of successfully managing outsourced formulation development and manufacturing projects.

  • Good knowledge of modern formulation technologies, including those for modulating skin penetration, 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).

  • Good knowledge and understanding of cGMP and of the US and Canadian regulatory environments.

  • 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 and communication skills and the ability to manage multiple competing priorities.

 

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