Head of Drug Substance Manufacturing

Reference No. R2786140 

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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