Responsible for day-to-day management of external Contract Manufacturing Organization(s) (CMO) specializing in Good Manufacturing Practices (GMP) manufacturing of Drug Substance and Drug Product of early and late-stage clinical programs.

Act as point of contact for contract research organizations (CROs) performing GMP drug product release and stability testing.

Create project artifacts, such as project plans, measures, team and stakeholder communications, status reports, and resource and time management.

Write project reports related to regulatory filings.

Establish and review process documentation, including batch manufacturing records, agreements, Certificate of Analysis (CoAs), deviations, change controls, etc.

Work with the Chemistry, Manufacturing, and Control (CMC) lead to project Active Pharmaceutical Ingredient (API) and Drug Product (DP) needs for preclinical and clinical programs (with the clinical team) and associated budgets (with the finance team).

Work with CMC lead to manage supply chain and logistics supporting clinical studies.

Manage and oversee International Council for Harmonization (ICH) stability studies for Cybin products.

Provide current reports on the inventory of DS and DP.

Manage CMC Development information to support regulatory filings.

Generate stability reports on Drug Substance (DS) and DP lots.

Manage and organize CMC workload for current and future goals to meet our milestones.

Follow current and emerging regulatory requirements and guidelines in the CMC field to advise other internal functions on possible implications.

Liaise with key stakeholders for scientific writing where needed and perform critical reviews of pre-Investigational New Drug (INDs), INDs, Investigational Medical Product Dossier (IMPDs), to ensure a high-quality regulatory submission.

Represent the company in regulatory authority communications or meetings as required.

Assist in encouraging continuous improvement across the functions.

Represent the company at project team meetings and provide expert technical advice to stakeholders.

Analyze and report data to our expected standards.

Ensure all activities follow standard operating procedures and/or protocols as required.

Work with other departments to resolve issues and implement corrective actions.

Ensure all interactions and engagements are carried out with the highest ethical and professional standards and that all work is accomplished with the highest quality.

Carry out other reasonable tasks as required by the line manager and handle special projects and initiatives as needed.