Director, Validation

Applied Pharmaceutical Innovation (API) brings life-saving research to the real world by helping life science innovators bridge the gap between academic research and commercial product development. We are driven compassionate and laser focused on making a dramatic positive impact with everything we undertake.

When you join API you are part of a rapidly growing team that is creating collaborative opportunities to commercialize Canadian life sciences discoveries increasing the amount of commercial research and development in the country and supporting Alberta as a key pillar in Canadas life sciences sector.

You will be part of one of APIs most important projects the Canadian Critical Drug Initiative (CCDI). The CCDI is a project led by API in partnership with the University of Alberta. It aims to establish an integrated research commercialization and manufacturing cluster in the Edmonton Metropolitan Region.

One aspect of the project involves upgrading the Biotechnology Business Development Centre (BBDC) in the Edmonton Research Park. The upgrade will include GMP-certified manufacturing suites for API-manufacturing chemical-physical testing and Health Canada-approved warehousing capacity.

The second part of the project is the Critical Medicines Production Centre (CMPC) which will be a new 83000 square-foot manufacturing facility located on a 7-acre plot of land in the center of the Edmonton Research Park. This facility is set to be Canadas largest and best-equipped of its kind. The CMPCs focus will be on producing small-molecule product solutions conducting sterile aseptic fill and finishing traditional and biologic drugs to meet drug shortages needs.

** Please note this position requires full-time on-site presence.

Key Responsibilities include but are not limited to:

Validation & Compliance top

• Set up validation strategies.
• Set up cleaning validation strategies and processes.
• Define cleaning limits for API-reaction vessels and formulation tanks with help of using the MACO-principle HBEL limits.
• Write and review validation protocols and reports in collaboration with the team.
• Write and review cleaning validation protocols and reports.
• Assist with and review media fill plans and reports.
• Ensure regulatory compliance and operational efficiency throughout process development and manufacturing scale-up.
• Prepare for and support regulatory inspections with global health authorities.
• Defend validation and technology transfer strategies during inspections.

Process Implementation & Scale-Up

• Responsible for commercial implementation of customer products or products transferred from Translational Services Division.
• Responsible for Product areas: Chemical-API-production (small to mid scale) and sterile liquid injectable products from Formulation Filling Terminal sterilization Inspection Packaging.
• Work closely with the Translational Services Division and R&D-departments to transfer new or generic products.
• Assist the Project Manager in project-planning and material and personnel resource capacity in Technical Operations.
• Support analytical method transfers and process implementation activities.
• Optimize manufacturing parameters to improve efficiency robustness and scalability.
• Define Critical process parameter for the production processes.
• Set up engineering batches and improvements until commercialisation.
• Perform process gap analysis fit-to-plant assessments equipment/process characterization and scale-up activities.
• Conduct FMEA-based risk assessments to support robust manufacturing processes.
• Implement SOPs and tools to support repeatable and efficient product implementation projects.

Manufacturing & Technical Operations

• Lead technical investigations and problem-solving activities supporting commercial manufacturing operations.
• Collaborate closely with the Translational Services Division Engineering Operations and Commercialization teams to identify suitable equipment vendors and process flows.
• Support layout design throughput optimization safety standards and facility fit considerations.
• Work with Procurement team together for implementation of Drug Substance and Drug Product material supply strategies including vendor and project management.

Documentation & Quality Systems

• Author and review technical documentation related to manufacturing activities including:
  • Development protocols and reports
  • Manufacturing batch records
  • SOPs
  • Change controls
  • Deviations
  • Regulatory submissions
  • Product impact assessments
• Draft and review production batch records in collaboration with Production teams.
• Interface with Production Quality Control and Compliance functions for:
  • In-process support
  • Analytical method transfers
  • Raw material release
  • Product release
  • Stability programs

HSE:

• Ensure the HSE- standards in the development laboratory.
• Evaluation of potential hazards and potential safety risks for new products and processes.

Qualifications - (Education Certification Degree Skills Knowledge etc.)

Education

• Minimum Masters degree in Chemistry Pharmacy Chemical Engineering or similar.
• Additional education in SixSigma principles or similar education is an asset.

Experience:

• Thorough knowledge of GMP FDA Health Canada and EU regulations (API-production and sterile manufacturing) and guidances combined with the ability to adopt best practices by responding quickly to a changing regulatory environment.
• 10 years experience in pharmaceutical validation process qualification and Product implementation within a GMP-regulated manufacturing environment.
• Deep knowledge in calculation cleaning limits based on the MAC principle under usage of HBEL is a must. Understanding PDE ADE and NOAEL dependencies.
• Demonstrated experience in sterile manufacturing including formulation filling visual inspection and packaging.
• Deep knowledge in pharmaceutical drug development chemical synthesis and pharmaceutical technology.
• Experience preparing for and supporting regulatory inspections with global health authorities.

Personal Competencies

• Strong oral and written communication skills with the ability to handle confidential information and frequent internal and external interactions.
• Strong project leadership and people management experience.
• Ability to manage time effectively and prioritize tasks in a fast-paced environment.
• Occasional moderate physical activity including laboratory work in a chemical synthesis laboratory standing walking lifting and keyboarding.
• Ability to meet deadlines and troubleshoot problems efficiently.
• Technically adaptable flexible and forward-thinking.
• Proficiency in Microsoft Office applications (Word Excel Outlook) and business-related software.

Working Conditions:

• Required travel between Edmonton API sites.
• This position requires you to be on site.
• Exposure to production environment.
• Work in production and office settings.

Additional Required Documents to Support Application

• Applications submitted without a resume AND cover letter will not be reviewed.

Perks and Benefits at API

Comprehensive Health Coverage: At API we prioritize the well-being of our employees. We offer a comprehensive health coverage plan. Our premiums are 100% covered ensuring that you and your dependents receive the necessary healthcare support.

Retirement Savings: API offers a RRSP Matching Program. Employees may be eligible to participate with API matching of contributions up to 13% of base salary in accordance with program terms.

Professional Development Opportunities: We foster a culture of continuous learning and growth. API provides access to various professional development opportunities including training programs workshops conferences and certifications. We encourage employees to enhance their skills broaden their knowledge and stay updated with the latest advancements in the life sciences industry.

Collaborative and Inclusive Environment: At API we believe in the power of collaboration and diversity. We foster an inclusive work environment that values and respects individuals from all backgrounds. We promote teamwork open communication and a supportive atmosphere where everyones contributions are valued.

Generous Paid Time Off: We understand the importance of taking time off to recharge and maintain a healthy work-life balance. API offers a generous paid time off (PTO) policy that includes vacation days medical/personal days and holidays. We encourage our employees to prioritize their well-being and enjoy quality time away from work.

Green Transit Allowance: Employees based out of an office are eligible to enroll in our green transit program which promotes the use of environmentally friendly modes of transportation. By participating in the program you commit to making green transit your primary mode of transportation for at least 75% of your commute to and from work. Green transit includes walking biking carpooling and public transportation.

Work From Home: Eligible employees are entitled to 20 Work from Home days this is subject to job function company needs and manager approval.

How to Apply

Interested applicants must submit a resume and cover letter expressing their interest in the position and why they believe they are a strong candidate.

We appreciate all applicants interest and will only contact those selected for interviews.

If you have any questions about the application process or require accommodations during the hiring process please contact .

Our team clients and stakeholders come from a variety of recruiting for our team we welcome the unique contributions that all people bring to the workplace in terms of varied lived experiences education culture gender race sexual orientation religious or ethnic background neurodiversity and cognitive and physical ability.

Before employment successful candidates will be required to meet the requirements of a pre-employment screening which includes background reference checks educational credential verification and criminal reference checks.

This position will remain open until filled.

Required Experience:

Director

Employment Type : Full-Time
Experience: years
Vacancy: 1