Job Description

Reference No. R2683956

Position Title: Manager, QC Immunochemistry

Department: Immunochemistry & Sample Management

Location: Sanofi Pasteur Limited, Toronto

Sanofi Vaccines

Sanofi\'s global vaccines business unit partners with the public health, medical and scientific communities to improve access to life-protecting vaccines and increase vaccination coverage, while striving to develop new and improved vaccines to enhance health and well-being.

At Sanofi, we chase the miracles of science to improve people\xe2\x80\x99s lives. We believe our cutting-edge science and manufacturing, fueled by data and digital technologies, have the potential to transform the practice of medicine, turning the impossible into possible for millions of people.

Position Summary:

Manage high volume Quality Control testing of vaccines by teams of analysts, in compliance with cGMP and Quality Systems; Manage regulatory commitments; Organize resources and test methods to meet testing demand forecast in the context of cutting edge technologies.

Key Responsibilities:

Supervise and coordinate daily operations to ensure on time testing while ensuring compliance:

Co-ordinate staff daily activities and work schedules to ensure prompt and accurate testing.

Establish and communicate testing priorities within area of influence in a timely manner.

Monitor workloads and re-assign tasks to ensure on time testing of product.

Monitor assay performance and accuracy through trending.

Maintain inventory control and ensure test continuity through reagent qualification within regulatory approval requirements.

Troubleshoot and resolve testing issues while ensuring regulatory and QA compliance is maintained. Brainstorm root cause and implement changes.

Ensure that test protocols and SOPs are implemented and followed in accordance with cGMP guidelines.

Conduct meetings to cascade information and present a venue for open communication and problem solving.

Address issues with staff such as job postings, hiring and performance management.

Ensure facility and equipment are properly maintained and validated.

Ensure that company safety and security policies are implemented and followed.

Accountable for ensuring optimal scheduling and capacity planning of work groups to maximize efficiencies. Participate in annual budgetary preparation and budget monitoring providing insight into department requirements current and future:

Ensure that daily activities and work schedules are effective for on time delivery of test results to meet product to market and license commitments.

Develop, refine and implement process changes to ensure optimal scheduling and capacity planning is maintained.

Work closely with SAP planner to identify testing priorities and ensure on time testing of products.

Ensure adequate equipment, staff, facilities are maintained for testing.

Monitor, track and review test forecast and testing recipes for accuracy and scheduling.

Identify budget capital needs.

Approve and review test results and documentation for accuracy and compliance with current testing procedures and regulations. Accountable for ensuring on time delivery of completed test documentation. Responsible for implementing and maintaining Quality Systems within the department in order to align with divisional objectives:

Ensure accuracy and compliance with cGMP.

Ensure documentation is expedited in a timely manner to facilitate the release of product to market.

Review and refine SOPs.

Maintain validation status of test methods.

Implement and maintain all Quality Systems within area of influence to ensure compliance within the department.

Ensure all staff have completed current cGMP training.

Respond to internal and external audits in a timely manner.

Focus on staff development; promote individual responsibility for personal and departmental improvement through the use of objectives and training initiatives. Establish development plans for staff to maximize current and future capacity requirements:

Establish \xe2\x80\x9cOn the Job Training Plans\xe2\x80\x9d for QC Immunochemistry staff so that the training is scheduled to maximize testing capabilities and ensure on time testing of products to meet company objectives.

Ensure proper training, orientation and probationary reviews of new employees.

Revise and update job booklets for all staff to reflect current duties and responsibilities.

Assess skill requirements for current and new test procedures.

Ensure that sufficient number of staff is qualified for test procedures to meet the testing needs of the company.

Provide coaching, guidance and monitor staff performance.

Promote teamwork and company values to sustain a productive working environment.

Cascade pertinent information in a timely fashion (e.g. Hold regular lab meetings).

Advise staff on growth and career development.

Investigate and develop new procedures and techniques to maximize efficiencies within the department. Improve and optimize testing procedures through test modifications and replacement, while investigating cost reduction measures.

Refine and optimize test procedures to ensure most cost effective and efficient means are being utilized while ensuring compliance.

Keep aware of current and novel techniques and processes to improve current practices.

Benchmark with others in the industry to gain knowledge of standard practices being utilized.

Actively network with global counterparts in the US and France on common issues.

Co-ordinate and monitor parallel testing, studies and projects.

Develop investigative protocols for process improvements.

Ensure compliance and communicate with QA and RA as required.

Relay technical information related to testing.

Plan, co-ordinate and execute activities related to identified process improvements.

Proactively scan external environment for new techniques, refined test methods.

Implement and follow all safety procedures and guidelines to ensure a safe working environment is maintained:

Ensure staff are educated and trained in safety procedures within the work place.

Responsible for ensuring that all staff attend required Health and Safety courses, e.g. WHMIS

Responsible for ensuring the availability and enforcement of the use of appropriate P.P.E. Implement Processes and procedures to ensure proper use and maintenance of PPE and safety equipment.

Ensure that safety audits are carried out on a monthly basis and that deficiencies are reported and dealt with in a timely fashion.

Ensure SDS sheets are current.

Ensure that staff immunizations are appropriate and up to date.

Troubleshoot and resolve repetitive testing issues. Actively seek out new types of equipment and or devices to improve current safety procedures.

Responsible for addressing and responding to Joint Health and Safety audit issues in a timely fashion.

Scope and dimensions:

Breadth of responsibility (global/regional/country/site):

On site test management and approval for product release to global markets.

Key dimensions: headcount (direct and indirect) budget, doses, Capex\xe2\x80\xa6 - Key indicators on which the job holder will be evaluated:

Supervises 4-10 union analysts or co-op positions.

Is responsible for project leadership, assignment and assessment of work performed by individuals or small groups of analysts as required within the department.

Provides technical and scientific support to other scientists and/or technical staff site wide and globally.

Supervises approximately 6,000 vaccine release tests per year.

Key Requirements:

Specific degree, duration of experience (Required to hold the job):

Master of Science in Immunology or a related field, such as Biochemistry, Biomedical Sciences or Molecular Biology, with 5 years previous relevant experience.

Alternatively, a Bachelor of Science degree and 8 or more years of previous experience in a high volume laboratory setting is required.

Cooperate Transversally.

Develop People.

Act for Change.

Sound knowledge and experience working in the field of Immunology and biological testing are essential to daily operations. This allows for the accurate assessment of test issues resulting in effective corrective actions to be derived, and is essential for optimization of current and novel testing procedures.

Sound knowledge and experience in animal testing is critical in understanding the capabilities and limits of the test procedures and in exploring new test methods.

Sound knowledge of the vaccine manufacturing process and critical quality attributes is essential to critically assess accuracy of tests in quantitation of product at various steps of manufacturing.

Sound statistical knowledge is critical to manage and refine test controls.

Organizational competency is key to maintain inventory control and schedule reagent qualification within regulatory approval requirements.

Ability to troubleshoot issues in an effective and timely manner as they arise on a daily basis.

Literacy in computer software programs pertaining to activities such as LIMS test information management, SOP maintenance, worksheet and log sheet administration, SAP functions and change control.

Ensure compliance and adherence to cGMP requirements, and have a working knowledge of applicable regulations and procedures, as they apply to the job functions, in order to ensure quality work and safety of self and co-workers.

Ensure that the Division level Quality Systems are adhered to at all times as they apply to the job functions.

Communicate clearly with laboratory staff and other customers and services to ensure smooth running of the laboratory. Deal with customers as issues arise.

Work with different groups of people to obtain the desired goals, within the department, division, and globally to ensure project goals and timelines are met.

Bring forth ideas for improvement and cost effective changes, surfs the net for new ideas, benchmark and network with industry peers.

Ensure compliance and adherence to cGMP requirements according to relevant SOPs. Accuracy in reporting (written), communication (oral).

Complete all scheduled activities within time frames allotted.

Complete work in a timely, accurate manner with minimal supervision.

Ability to train current and new staff and upgrade own skills as required.

Ability to recognize problems, identify possible solutions and inform Director and/or designate without delay.

Ability to work independently as well as part of a team.

Organizational skills, flexibility and efficiency are essential.

Pursue Progress

Discover Extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn\xe2\x80\x99t happen without people \xe2\x80\x93 people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let\xe2\x80\x99s be those people.

Watch our and check out our Diversity, Equity and Inclusion actions at !

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.

Thank you in advance for your interest.

Only those candidates selected for interviews will be contacted.

#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.

Sanofi