Manager Product Transfer

Applied Pharmaceutical Innovation (API) brings lifesaving 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 GMPcertified manufacturing suites for APImanufacturing chemicalphysical testing and Health Canadaapproved warehousing capacity.

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

** Please note this position requires fulltime onsite presence.

Key Responsibilities include but are not limited to:

Process Development & ScaleUp

• Responsible for scaling benchtop processes to pilot scale and commercial production (API and sterile production) optimizing manufacturing parameters and supporting process validation.
• Drive the scaleup activity for sterile product & API development turning technical product specifications and manufacturing specifications into implementable action plans.
• Design and implement standard scaleup process templates and transfer SOPs and tools that can be utilized across different product implementation projects ensuring repeatable success and efficiency in scaling operations.
• Perform process gap analysis fittoplant evaluations equipment and process characterization scaleup and FMEAbased risk assessments.

Technology Transfer & Implementation

• Lead the endtoend tech transfer process from Development to Operations.
• Develop tech transfer plans and validation studies including critical process parameters critical quality attributes and production readiness criteria.
• Define the process production implementation and transfer process together with the Technical Operations team.
• Primary process development leader to ensure smooth transitions of technology transfer.
• Act as the project manager for product transfer and implementation integrating internal and external team members activities into the operating plan and presenting plans and progress to the Senior Leadership Team.

CrossFunctional Collaboration

• Work closely with Engineering Operations and Commercialization teams to identify suitable equipment vendors and process flows (layout design throughput optimization safety standards).
• Collaborate with Regulatory and QA colleagues to plan coordinate and execute internal and external drug product development and manufacturing.
• Interface with Production Quality Control and Compliance teams including inprocess and analytical method transfers raw material release production product release stability and analytical method transfers.

Regulatory & Compliance

• Ensure regulatory compliance and efficiency across all phases of process development and manufacturing scaleup.
• Prepare for and support regulatory inspections with global health authorities defending validation qualification and tech transfer strategies.
• Author and review technical documentation including development and transfer protocols and reports manufacturing batch records SOPs change controls deviations regulatory submissions and product impact assessments.
  

Manufacturing Support & Strategy

• Evaluate manufacturing options scale product & process development and oversee commercialization and tech transfer to operations.
• Oversee the development and implementation of overall Drug Substance and Drug Product material supply strategies and manage associated vendors and project plans.
• Lead technical investigations and problemsolving in support of commercial manufacturing.

Leadership & Department Management

• Manage department activities including administrative tasks resourcing planning training and performance management.
• Maintain key performance indicators aligned with departmental and product supply goals.
• Use continuous improvement principles to identify and evaluate opportunities to improve KPIs in the production environment.

Health Safety & Environment (HSE)

• Ensure HSE standards are maintained during the development and transfer of new products.
• Evaluate potential hazards and safety risks for new products and processes.

Quality & Culture

• Help drive a quality GMPdriven culture by teaching and coaching others within the organization.

Qualifications (Education Certification Degree Skills Knowledge etc.

Education

• Minimum Masters degree in Chemistry Pharmacy Chemical Engineering or similar field
• Preference will be given to candidates with an advanced degree. (PhD)
• Additional education in Six Sigma principles or similar education is an asset.
• PMP certification an asset.

Experience:

• Thorough knowledge of GMP FDA Health Canada and EU regulations (especially sterile manufacturing) and guidances combined with the ability to adopt best practices by responding quickly to a changing regulatory environment.
• 5 years experience in pharmaceutical validation process qualification and technology transfer within a GMPregulated manufacturing environment.
• 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 fastpaced environment.
• Occasional moderate physical activity including standing walking lifting and keyboarding.
• Ability to meet deadlines and troubleshoot problems efficiently.
• Technically adaptable flexible and forwardthinking.
• Proficiency in Microsoft Office applications (Word Excel Outlook) and businessrelated software.

Working Conditions:

• This position requires onsite presence
• 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 wellbeing 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.

Payment in Lieu of Pension: API provides an additional 15 of your annual base salary as an alternative to traditional pension benefits.

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 worklife 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 wellbeing 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 10 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 backgrounds. In 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 preemployment screening which includes background reference checks educational credential verification and criminal reference checks.

Application Deadline: May 6 2025