Director - Manufacturing, Science and Technology (MSAT)

Bora Pharmaceuticals•Mississauga, ON

2d•Hybrid

About The Position

Bora Bora Pharmaceuticals is a premier international contract development and manufacturing organization (CDMO) specializing in formulation development, clinical and commercial manufacturing, and packaging of complex oral solid dose, liquid, semi-solid, biologics, and sterile injectable pharmaceutical products. From our world-class sites in North America and Asia, we deliver drug products with unparalleled quality to more than 100 markets around the world. Bora’s teams, technologies, and facilities work seamlessly together to enable our clients to deliver much-needed therapeutics to patients worldwide. At Bora Pharmaceuticals, we see it as our mission, our duty, our responsibility, to make our success and our customer’s success more certain. 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. 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.

Requirements

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

Nice To Haves

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

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.