Position Status

This is a permanent fulltime position.This job posting reflects a current vacancy within the organization. The position is active, approved, and intended to be filled as part of our staffing needs. This posting is for an existing and currently open position.

General Description

Responsible for transfer in and development for all new products coming into the Mississauga site, full drug development including Pre-formulation/Formulation development and method development; Analytical method transfers and validation; All aspects of Technical Transfers including development and GMP Manufacturing, packaging, cleaning and process validation, and oversight of Development QA. Working with Business Development team to support and assist in securing new customers. Ensuring that all Technical Aspects for products in commercial are managed well through the validation lifecycle.

Key Responsibilities

• Working with Business Development to secure new business across the network, through identifying fit to plant to manufacture & package, looking critically at RFPs and joining in the financial reviews on costs. Largely an external client facing role.
• Full accountability for agreed revenue targets for new business and management of the MSAT P&L, promoting growth opportunities for the site and adhering to opex budget.
• Maintain department by recruiting, selecting, orienting, and training employees; maintaining a safe and secure work environment; developing personal growth opportunities of team. Development of staff to have a secure succession plan for department.
• Maintains professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; benchmarking practices.
• Maintains compliance with all relevant EHS and cGMP regulations with the department.
• Contributes to site leadership team by engaging and influencing strategic decisions for the site.
• Management of Pilot plant area as a new business unit on site for manufacturing and packaging.
• Own the strategy and execution of process validation (PPQ) and continued process verification (CPV) for new and existing products at the site. Ensure risk-based validation approaches using tools such as FMEA, risk assessments, and control strategy development.
• Lead the site strategy for analytical method qualification, validation, transfer, and lifecycle management for in-process, release, and stability methods.
• Accountability for all Technical aspects for commercial business, including manufacturing, packaging and customer or new product changes.
• Ensure new product introductions are executed in compliance with cGMP requirements, and changes to existing products are effectively managed in accordance with cGMP standards.

Experience and Skills

• 10 years of pharmaceutical manufacturing in Technical function or elsewhere within the industry.
• High level of experience in Product Lifecycle Management, Technical Transfer and Product Development, within a pharmaceutical contract manufacturing organization.
• Specialist Technical competence and unit dose knowledge in Oral Solid Dose, liquid and semi solid dose forms.
• Operational Management skills and experience.
• Proven capability to lead teams (both line and matrix) to deliver business solutions and benefits.
• Proven ability to communicate and influence effectively at all levels within the organization.
• Ability to use and interpret data to drive decision-making at both tactical and strategic levels.

Education

Required:
Bachelor's or Master's degree (B.Sc. or M.Sc.) in a scientific or engineering discipline.

Preferred:
Master's degree or other postgraduate qualification in Chemistry, Engineering, Pharmaceutical Sciences, or a related discipline.

Working Conditions

• Primarily office-based role with occasional presence required in manufacturing and production areas.
• Minimal travel may be required based on business needs.

Additional Information

In accordance with Ontario's pay transparency requirements, candidates will be notified when they are no longer under consideration or once the vacancy is closed. Updates regarding application status may be communicated via email or through the online applicant profile, where applicable.

As part of our recruitment process, we may use technology-assisted tools, including automated systems, to support the review and assessment of applications. These tools do not make final hiring decisions. All decisions related to screening, interviewing, and selection are made by our Talent Acquisition and hiring teams.

Benefits Include:

We offer a comprehensive benefits package designed to support our employees' wellbeing, including:

-Competitive salary and performance-based incentives

-Comprehensive health coverage including medical, dental, and vision insurance

-Retirement savings plans with employer contributions

-Paid time off and flexible work arrangements

-Professional development opportunities

-Employee wellness programs and resources

-Employee Assistance Program and Mental Health Resources

At Bora, our values guide everything we do - from how we solve challenges to how we support our people. We lead with a solutions-first mindset, strive to do the right thing, stay proactive, and above all, respect everyone.