Reference No. R2786140
Position Title: Head of Drug Substance Manufacturing
Department: Manufacturing and Supply CA
Location: Toronto, Ontario
About the Job
We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.
The Head of Drug Substance Manufacturing is responsible for leading the drug substance manufacturing value chain for the Sanofi Manufacturing & Supply organization in Toronto, Canada. The span of responsibility covers all drug substance production across multiple production buildings. The Head of Drug Substance Manufacturing ensures that operation of the people, equipment, and processes are compliant and meet the regulatory requirements. This includes leading programs to improve employee safety, improve quality, increase production efficiencies, reduce costs, and increase employee engagement as per established goals. This position also plays a key role in development and implementation of medium and long-term strategic plans, anticipates future business and customer’s needs, driving a quality and continuous improvement mindset on the operations floor, teamwork across all functions, and people and team development to reach the goal of high performance for the Toronto site.
We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?
Main Responsibilities:
Accountable for all drug substance production facilities on site to ensure that sufficient product is manufactured at the appropriate level to meet supply chain requirements
Manage manufacturing performance to meet Corporate Strategic and Operation objectives through establishing, approving, and analyzing manufacturing activities
Ensure all product operations are conducted in compliance with cGMPs, and regulations
Interface with MSAT to ensure Manufacturing processes are validated
Lead start-up efforts for new manufacturing capacity, including ensuring regulatory approvals. Develop product introduction strategies, staffing plans, and work plans that deliver new capabilities to timelines defined by business strategy
Responsible for investigating and correcting deviations or departures from expected performance levels
Provide leadership and direction to ensure Inspections, Deviations, Change Control, CAPAs and Regulatory commitments are met on time with the highest standards of quality
Working closely with the Head of Site Quality, share responsibility for the inspection, investigation, and taking of samples, to monitor factors which may affect product quality
Establish programs, processes and the right culture to ensure an effective Safety culture
Ensure all Manufacturing operations operate in compliance with Health, Safety and Environmental regulations
Responsible for engaging, investigating, and correcting departures from expectations to ensure the highest safety standards are maintained
Deliver financial results in accordance with plan and forecasts
Meet all cost of goods targets by managing manufacturing performance through establishing, approving, and analyzing operational expenses, headcount, capital appropriations and inventory levels
Establish programs, practices and processes to drive a high-performance culture across Safety, Quality, Delivery, Cost and Involvement via the Sanofi Manufacturing System (SMS)
Develop and lead an agile, highly trained organization, from shop floor technicians, through the Toronto Manufacturing & Supply SLT and respects company values and culture
Build a high-performance leadership team and ensure strong alignment and coordination of all functional groups on site
Serves as a member of the Manufacturing & Supply Senior Leadership Team and works cross-functionally to respect the needs of business partners within Manufacturing, Supply Chain, Quality, MSAT and Engineering and Maintenance
Ensures continuous Manufacturing Improvements are defined and implemented
Systematically identifies facilities, equipment, utilities and processes that require improvements and ensures these improvements and/or investments are budgeted and effectively implemented
About You
Qualifications:
Bachelors or Masters degree in Engineering or other Science related discipline
Masters level degree in technical field (i.e. chemical/mechanical engineering) or MBA with solid business training, is desirable
15+ years direct experience in pharma/biotech manufacturing, and quality environments/organizations
10 years demonstrated leadership in behavioral competencies
Strong GMP background including working knowledge of GMP
Good understanding of continuous improvement methodologies and experience working within a lean production system
Diverse business, quality, and industrial manufacturing knowledge base
Strong technical and leadership skills required to lead production units
Strong cross-functional working skills to cut across organizational boundaries within and outside of manufacturing
Demonstrated proficiency in strategic thinking, organizational change management, ability to influence is preferred
Direct management and transversal management skills
Fluent in English, both written and spoken
Strong abilities to coach and animate to drive transformation
Ability to take timely and data-based decisions in a fast moving and complex environment to drive performance and progress
Demonstrated ability to develop employees to reach their highest potential
Excellent communication skills and ability to inspire and motivate is preferred
Strong collaboration skills
HSE requirements
Supervises and monitors compliance with employment and health and safety legislation to ensure that employees work within the policies, procedures and regulations applicable to their work.
Participates in the investigation of incidents and work-related illnesses
Responds promptly to all health and safety concerns or incidents and completes the appropriate documentation in a timely manner
Takes every reasonable precaution to ensure the health and safety of staff
Ensures that protective equipment and clothing required is used by staff
Cooperates and assists the Joint Health and Safety Committee in carrying out its functions
Advises staff of any potential or actual health and safety hazard of which they are aware
Why Choose Us?
Bring the miracles of science to life alongside a supportive, future-focused team.
Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs
The opportunity is a REPLACEMENT.
Sanofi is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. We welcome and encourage applications from all qualified applicants. Accommodations for persons with disabilities required during the recruitment process are available upon request.
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