Full-Time

B100 Operations Manager-Vaccines

Posted on 11/16/2024

Sanofi

Sanofi

10,001+ employees

Develops pharmaceuticals and life-saving vaccines

Biotechnology
Healthcare

Junior, Mid

Toronto, ON, Canada

Category
Public Health
Biology Lab & Research
Biology & Biotech
Requirements
  • Preferred post-graduate in Microbiology/Biochemistry/Engineering or Related Science
  • Minimum BSc in Microbiology/Biochemistry/Related Science with experience and additional business and management training.
  • 2-3 years people management + cGMP experience
Responsibilities
  • Supports the design of B100 relevant operations through remaining stages of project
  • Review and approve technical and quality related documentation.
  • Administration of Miscellaneous equipment (user access, periodic review, audit trail management)
  • Development and ownership of production schedules to support validation, engineering runs and full scale manufacturing
  • Manages scheduling of preventative maintenance plans, spare parts, BOMs.
  • Supports development of manufacturing recipes
  • Supports execution of validation activities related to equipment, process and facilities
  • Ensures project support and production activities are executed as per defined schedules
  • Monitors & communicates team performance with respect to deliverables using visible metrics
  • Supports operations execution on the shop floor (MES, PCS)
  • Responsible for development and life cycle management of documentation related to manufacturing operations (eBPR, Logs, etc)
  • Supports development of operating budget and staffing for operations and project related activities.
  • Develop communication approach for operations topics to ensure project milestones are met (escalation, cascading)
  • Works with QOOQ, QOSA and RA to ensure compliance with GMP requirements, develop quality continuous improvement initiatives, develop staff quality culture and GMP knowledge
  • Leads development and maintenance of operating procedures in adherence to global and site policies
  • Ensures compliance of facilities & equipment; minimize process deviations and environmental incidences, identify root cause and implement corrective/preventative actions.
  • Supports the development of lesson plans, ensure training is completed in a timely manner. Ensure lesson plans are updated appropriately and training remains current.
  • Conducts inspections for manufacturing operations (GEMBA, MSV)
  • Point of contact (lead) for internal/external audits, regulatory inspections, regulatory responses
  • Organizes and develops staff to ensure a high performing team; establishes, monitors and provides individual feedback on staff objectives; ensures training of staff according to training plans and to continue to develop their competencies; coach staff on personal development goals and document follow up
  • Contributes to the B100 management team, communicates and co-operates with other departments to obtain consensus and ensure appropriate service levels
  • Hire new employees and follow company’s procedures; responsible for attendance management and time reporting system.
  • Implement and execute lean management systems established for Bulk; ensures continuous improvement of processes; troubleshoot and lead resolution for manufacturing issues
  • Identify and lead initiatives to increase process efficiency, quality and/or yield; implements solutions or changes via change control; plans and manages facility and organization improvements
  • Provides metrics and other reports as requested
  • Ensures that employees work within the policies, procedures and regulations including responding promptly to all health and safety concerns or incidents
  • Ensures all critical incidents and accidents are reported to the appropriate authorities; potential safety and health hazards are identified communicated to staff as lessons learned
  • Ensures that that personal protective equipment and clothing are available and appropriate for the tasks
  • Ensures continuous EHS awareness and improvement by integrating team with site and Bulk initiatives
  • Cooperation with and assistance to the EHS management and Joint Health and Safety Committee in carrying out their functions.

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%
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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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