Lead Process Chemistry efforts in facilitating drug substance development and manage CDMOs across all stages of drug development.
Compensation
The expected salary range for the role of Director, CMC Process Chemistry is $206,000 - $254,000.
Responsibilities
Lead Process Chemistry efforts in facilitating drug substance (DS) development by managing multiple CDMOs across all stages of drug development
Author and review technical development reports, batch records, campaign reports, change controls, corrective and preventative actions, deviations, and investigations
Author and review necessary technical sections in IND/IMPD/NDA documents supporting global CMC regulatory submissions
Represent DS/CMC and participate in cross functional project teams and manage multiple priorities in a fast-paced, dynamic environment
Collaborate closely in cross-functional teams including Medicinal Chemistry, DMPK, Analytical Chemistry, Formulation, Toxicology, Quality, Project Management, CMC Regulatory, Development Sciences, and Clinical Pharmacology
Requirements
Ph.D. in Chemistry
M.Sc. in Chemistry
Nice to have: late phase and commercial experience
Nice to have: small molecule ADC payload/linker manufacture
The Supervisor, Production is responsible for all aspects of a specific business unit within the Liquid Dose Production facility, including ensuring that all work is performed in compliance with Safe Work Practices, cGMP, Standard Operating Procedures, and company policies.
Compensation
The hiring range for this position is $83,958.00 - $139,930.00 CAD per year. The final agreed-upon salary may vary based on factors such as job-related knowledge, skills and experience.
Responsibilities
Provide results oriented leadership that drives continuous improvement consistent with the Operations Business Objectives
Co-ordinate, assign and supervise all production activities and outcomes for area of responsibility to ensure production schedule/agreed upon goals and objectives are met
Use systems and metrics to guide the initiation and execution of safety, quality, productivity and continuous improvement initiatives in support of the Operations Business Objectives
Provide strong leadership to the team that fosters personal development, interaction and participation, including coaching and administration of the Apotex Compatibility Process where necessary
Provide leadership as a member of the Production leadership team, building and maintaining positive relationships with the key business partners within and outside of Production
Requirements
Post-Secondary Diploma or Degree in Pharmaceutical Sciences, Engineering or related field
Nice to have: Previous experience in the Food, Consumer Packaged Goods or Pharmaceutical industry
Provide leadership and oversight for manufacturing operations within Cell Therapy while ensuring a safe, compliant, and efficient production environment.
Compensation
Compensation for this role will be determined by the candidate’s qualifications, skills, experience, and relevant knowledge.
Responsibilities
Provide a safe, controlled work environment and ensure site safety objectives are communicated and understood by all manufacturing personnel.
Lead manufacturing teams and serve as the subject matter expert for assigned operations, including areas such as Cell Growth, Drug Product Filling, and related manufacturing processes.
Provide in-suite oversight during critical manufacturing activities such as harvest, vial filling, visual inspection, and other key production operations.
Support technical transfer activities, including process execution, methods transfer, engineering runs, training runs, water runs, and qualification activities.
Collaborate with Quality Assurance and cross-functional teams to establish procedures, quality systems, and manufacturing strategies for new and existing programs.
Requirements
Bachelor’s degree
Nice to have: automated drug product filling systems
Nice to have: RABS
Nice to have: isolator technology
Nice to have: automated or manual visual inspection systems
Lead and own process and equipment systems across the full lifecycle, providing technical leadership, design reviews, vendor coordination, and ensuring compliance with GxP and regulatory requirements.
Compensation
The expected base salary range for this position at hiring is $135,000 - $160,000. In addition to base salary, total compensation for this role may also include incentive compensation and equity.
Responsibilities
Own assigned process and equipment systems across the full lifecycle
Translate process, product, regulatory, operational, maintenance, and safety needs into user requirements, technical specifications, system risk assessments, design criteria, and acceptance requirements
Provide technical leadership and documented owner input during process, equipment, piping, automation, facility-interface, constructability, operability, maintainability, contamination-control, and safety reviews
Coordinate technical interfaces among internal functions, A/E partners, equipment vendors, integrators, and construction/CQV teams
Plan and support vendor document reviews, FAT, SAT, commissioning, troubleshooting, qualification, punch-list resolution, turnover, and package closeout
Requirements
Bachelor’s degree in an Engineering or Science discipline
Nice to have: technical experience with plasma or biological-material thawing
Nice to have: container opening
Nice to have: liquid pooling and transfer
Nice to have: automated material handling/robotics
Senior Specialist, Clinical Supplies Quality, Global Development Quality responsible for supporting the Clinical Supply Chain for clinical development programs, ensuring reliable availability, quality and regulatory compliance of clinical supplies.
Compensation
$106,200.00 - $167,200.00
Responsibilities
Provide in-depth technical and quality expertise regarding clinical supply operations and integration
Develop and execute quality and stakeholder strategies
Evaluate and disposition clinical supply materials
Coordinate and support investigation of deviations and significant quality events
Identify trends and lead resolution of significant quality issues
Lead the transformation of Vertex’s global Quality operations through AI, data, and technology, driving strategic vision, roadmap, and execution across multiple business units.
Compensation
$256,000 - $384,000
Responsibilities
Develop and communicate a clear vision for AI-powered Quality technology solutions across Vertex’s global operations
Shape a strategic roadmap applying generative AI, agentic AI, machine learning, data products, and data-driven automation to transform Quality processes
Partner with Quality leadership to accelerate portfolio and commercial priorities while enabling operational excellence
Lead strategic thinking across Quality oversight, inspection readiness, batch release, compliance, and related global Quality activities
Influence stakeholders across a broad internal and external ecosystem to identify and prioritize opportunities for innovation
Requirements
Bachelor’s degree in a relevant field (e.g., Business, Computer Science, Engineering)
Nice to have: Experience leading AI, data, or technology transformation in a global pharmaceutical Quality organization
Nice to have: Experience supporting clinical and commercial supply operations
Nice to have: Experience working across CMC, Manufacturing, Supply Chain, Quality, and R&D functions
Nice to have: Experience partnering with external technology suppliers and service providers in highly regulated environments
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