Full-Time

Operations Manager

Media, Washing and Sterilizing-Vaccines

Posted on 11/18/2024

Sanofi

Sanofi

10,001+ employees

Develops pharmaceuticals and life-saving vaccines

Biotechnology
Healthcare

Senior

Toronto, ON, Canada

Category
Healthcare Administration & Support
Medical, Clinical & Veterinary
Requirements
  • Minimum BSc in Microbiology/Biochemistry/Engineering or Related Science(s)
  • At least 5 years of experience in pharmaceutical industry/manufacturing (people management experience preferred)
  • Business and/or management training would be an asset
  • Experienced with manufacturing automation (e.g., DeltaV) and/or electronic batch records would be an asset
Responsibilities
  • Participate in the design, commissioning, startup, and troubleshooting of MWS processes (Raw Material receipt/handling/storage, Weighing & Dispensing, Buffer Preparation, Decontamination, Washing & Sterilizing) and equipment operations through all stages of project (C&Q, IQ/OQ, Engineering and Consistency runs, full operations)
  • Manage the procurement process and readiness of small equipment within Operations for engineering runs and start-up
  • Review and approve technical and quality related documentation (P&ID, IOQ, PPQ, and design documents)
  • Provide troubleshooting and problem-solving guidance for daily project and manufacturing issues, and implement preventative/corrective actions
  • Participate in and support the incorporation of digital technology (e.g., electronic batch records and e-logbooks) into manufacturing process in the new facility to reduce costs and to improve quality and delivery capability
  • Develop and execute production schedules from project through full scale manufacturing, ensuring that project support and production activities are executed as per defined schedules
  • Lead operations team execution on the shop floor for equipment, processes, and facilities. Monitor and communicate team and project performance with respect to deliverables using visible metrics.
  • Support development of operating budget and staffing for operations and project related activities from design to start-up
  • Develop communication approach for operations topics to ensure project milestones are met (e.g., escalation, cascading)
  • In collaboration with OQ, ensure compliance with GMP requirements, develop quality continuous improvement initiatives, develop staff quality culture and GMP knowledge.
  • Ensure that all Operating Procedures, training plans, and manufacturing documentation are current, developed in adherence to global and site policies, and completed in a timely manner.
  • Through appropriate shop floor oversight, ensure that facilities & equipment are compliant, and that process and environmental deviations are addressed in an expedited and compliant manner.
  • Support internal and external regulatory audits/inspections and coordinate appropriate responses
  • Organize and develop staff to ensure a high performing team. Provide individual feedback on staff objectives and development, coaching each team member on personal development milestones.
  • Contribute to the B200 Operations management team, communicate and co-operate cross-functionally to achieve project and operational goals.
  • Hire and on-board new employees, manage team attendance and performance.
  • Develop and oversee technical training plan to ensure training compliance for all shop-floor staff
  • Implement lean management systems and continuous improvement of processes established for IA.
  • Challenge status quo: identify and lead initiatives to increase process efficiency, quality, and/or yield.
  • Implement solutions or changes via change control, plan and manage facility and organization improvements
  • Provide metrics and other reports as requested, including the scheduling of PM plans, spare parts, BOMs
  • Ensure that employees work within the policies, procedures and regulations including responding promptly to all health and safety concerns or incidents; critical incidents and accidents are reported to the appropriate authorities; potential safety and health hazards are identified and known by staff and that protective equipment and clothing are required and are used; continuous HSE awareness and improvement by integrating team with site and Bulk initiatives
  • Cooperation with and assistance to the HSE management and Joint Health and Safety Committee in carrying out their functions
  • Ensure complete and comprehensive safety training of staff
  • Must have full understanding of all Hazard and Operability Analysis (HAZOP) and awareness of all Hazard Identification (HAZID) pertaining to Operations equipment and processes

Sanofi provides healthcare solutions through its pharmaceutical and biotechnology products, focusing on treatments and vaccines for various medical conditions. The company conducts extensive research and development to create new therapies and improve existing ones, particularly in areas like immunology, oncology, and rare diseases. Sanofi's products include prescription medicines, over-the-counter items, and vaccines, which are distributed to patients, healthcare professionals, and governments. What sets Sanofi apart from its competitors is its strong emphasis on scientific innovation and strategic partnerships, allowing it to maintain a diverse product pipeline and a global presence. The company's goal is to enhance health outcomes and improve the quality of life for individuals worldwide.

Company Stage

Grant

Total Funding

$2B

Headquarters

Paris, France

Founded

N/A

Growth & Insights
Headcount

6 month growth

0%

1 year growth

0%

2 year growth

0%
Simplify Jobs

Simplify's Take

What believers are saying

  • Sanofi's strong financial performance, as evidenced by its raised 2024 outlook, indicates robust growth and stability.
  • The company's strategic investments in innovative biotech firms, such as Ventyx Biosciences, enhance its pipeline and potential for breakthrough therapies.
  • Sanofi's Dupixent receiving a positive recommendation for expanded use in children demonstrates its leadership in addressing unmet medical needs.

What critics are saying

  • The highly competitive pharmaceutical market requires Sanofi to continuously innovate to maintain its market position.
  • Regulatory challenges in different regions could delay product approvals and impact revenue streams.

What makes Sanofi unique

  • Sanofi's extensive R&D efforts and strategic partnerships, such as with Orano Med for radioligand therapies, set it apart in the competitive pharmaceutical landscape.
  • The company's global reach and focus on patient-centric solutions allow it to effectively navigate diverse regulatory environments and deliver innovative treatments worldwide.
  • Sanofi's investment in sustainable initiatives, like SureChill's 'Cooling as a Service' model, highlights its commitment to addressing healthcare challenges in emerging markets.

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