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Production Manager, Adsorptions - (Toronto, Ontario, Canada)

Sanofi

 -
Toronto - Canada
Full-Time Job Apply Method - External site
Posted Date - February 26, 2020 Expiry Date - N/A
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Job Description
  • Production Manager, Adsorptions Full Time Opportunity Position Summary: The incumbent is responsible for the adsorption of CP products and Diphtheria/Tetanus in compliance with cGMP, and is accountable for the administration and supervision of the Adsorption Department in Bulk Manufacturing.  The incumbent is responsible for the preparation of all necessary documentation required to release the products to Formulations, and is responsible for supervising the activities of the staff in the department.  This includes being accountable for the efficiency and accuracy of the formulation processes and documentation; adherence to SOPs, cGMPs and safe work procedures; quality assurance and improvements; maintenance of the Adsorption facility and effective scheduling and control of expenses. The incumbent will act as a core member of the Autonomous Production Team (APT) and participate in all cross-functional activities to support the B90 APU. Key Accountabilities: Supervise the aseptic formulation activities including cP Antigen adsorption, Diphtheria and Tetanus adsorption (25%): Plan daily work schedule for 2 cleanrooms/ 2 shifts. Ensure SOPs, BPRs are adhered to, oversee maintenance of production equipment and clean rooms. Plan detailed schedule for the area to ensure delivery of product to meet demand. Co-ordinate and monitor document review of batches manufactured. Perform supervisory roles & hiring, & maintain a high level of performance from employee reports. Plan work schedule with Divisional Planner to meet SAP requirements (20%) : Work with planner, scheduler & formulation departments to meet delivery times. Maintain, and update BOMs, recipes and material master data. Coordinate activities to ensure cleaning, validation, EM requirements, training, maintenance and safety programs are met. Maintain manufacturing cycle times & improve on time deliveries based on customer requirements.   Maintain documentation including BPRs, SOPs, Process Descriptions and Test Requirements with the relevant QO and MTech department personnel to meet cGMP documentation requirements (20%): Review and approve documentation for all products produced in Adsorption department, including BPRs, SOPs, filter integrity tests, equipment records, log books, particle counts and Deviation investigations. Update and approve revisions to master batch records, in compliance with change control procedures. Maintain high level of security & document integrity for all files in orderly manner for review & retrieval. Participate in special projects to assist development goals, maintain stability programs and improve production processes to simplify procedures, meet new GMP requirements or reduce costs to division (15%): Execute validation protocols to maintain compliance, while reducing manufacturing costs without compromising product or licenses. Meet with other departments to assist projects needed for product licensing, cGMP improvements and better customer service.                                               Maintain 2 clean rooms to meet cGMP requirements including aseptic validation, personnel training, daily cleaning and environmental monitoring activities (10%): Maintain clean room requirements during manufacturing operations; ensure log books are up to date on a routine basis. Schedule routine and emergency maintenance with Technical Services, including certification of HEPA filters, particle counters, scales, weight & integrity testers as per QO policies.        Lead regulatory inspection tours in the area, and respond promptly to all regulatory requests.                       Maintain large controlled inventory for manufacturing (10%): Maintain inventory in controlled refrigerator units to meet cGMP cold chain; maintain 4 refrigerators. Ensure safe transport of products to Formulations weekly. Responsible for approving purchase orders and following approved budget.                                  Scope and Dimensions: As a core APT member, plans the strategy and execution of the production schedule in collaboration with a team including QO, MTech, Maintenance, Supply Chain, and other production members. Oversees the preparation of all adsorbed components for bulk formulations - APW, CP Adsorbed antigens, T & D Adsorbed antigens, including all licensed products and new formulations as required for worldwide product distribution. Education and Experience: Preferred MSc in Microbiology/Biochemistry/Related Science 36 months in Aseptic Manufacturing in a pharmaceutical clean room environment Must be able to lead through example and possess managerial skills for handling a group of individuals (building/leading/training a team) Good knowledge of cGMP in pharmaceuticals/biological is essential Understanding of key activities including sterile manufacturing and aseptic techniques Experience in validation, aseptic processing, sterilization & disinfection, sterile broth fills & formulations Good problem solving skills and documentation skills, clear written and oral communication Ability to lead a group handling high value products Knowledge of Excel, Word, Outlook and PowerPoint Sanofi Pasteur: The world’s leading vaccine company Sanofi Pasteur, the vaccines division of Sanofi, is the largest company in the world devoted entirely to human vaccines. Our driving goal is to protect people from infectious diseases by creating safe and effective vaccines.  Our company distributes more than 1 billion doses of vaccine each year, making it possible to vaccinate more than 500 million people across the globe.  Sanofi Pasteur offers the broadest range of vaccines in the world, providing protection against 20 bacterial and viral diseases. Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.  With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Sanofi is an equal opportunity employer committed to diversity and inclusion. Our goal is to a ttract, 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. Thank you in advance for your interest. Only those candidates selected for interviews will be contacted. Sanofi, Empowering Life #GD-SP #LI-SP At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

 

About Sanofi
Sanofi is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, Sanofi transforms scientific innovation into healthcare solutions, in human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes and cardiovascular solutions and consumer healthcare. More than 110,000 people at Sanofi are dedicated to make a difference on patients’ daily life, wherever they live and enable them to enjoy a healthier life.

 

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