Downstream Process Development Jobs in Ontario (NOW HIRING)

Main Responsibilities: 

Execution of Media, Buffer, Washing, and Sterilization & inoculation preparation activities

• Assist in review of Records, SOP, logbooks, and monitoring charts for completion and ensure accuracy of all documents as per GMP guidelines.
• Train and ensure technical staff comply to GMP, HSE, and SOP requirements.
• Participate in daily meetings and report findings to management.
• Participate in deviation investigations and root cause analysis.
• Coordinate with units within department (MWS, Upstream and Downstream)
• Provide training to personnel.
• Execute and verify IQ/OQ/PQ validation and cleaning verification protocols.
• Perform other duties as assigned by department management throughout all stages of drug substance manufacturing related to (MWS, Upstream and Downstream processes).

Preparation of media, washing and sterilization, inoculum, analytical testing, area monitoring, maintenance, material handling, warehouse

• Perform activities and documentation involved in MBWS and Upstream including, in buffer preparation, washing and sterilizing, inoculation preparation, infectivity testing, and material handling.
• Perform production calculations, measurements, and release checks. Ensure each cleaning meets standards set in SOP, records, and in accordance with GMP.
• Observe in detail and report any process deficiencies, perform visual inspection of equipment for impurity and damage before and after cleaning.
• Perform utility sampling and environmental monitoring as required and ensure the completion as adhered to schedule.
• Provide guidance to technical staff on problem solving and trouble shooting.
• Ensure area is inspection ready. Knowledgeable to guide inspectors.
• Material handling, movement an organization and storage. Reorder parts as per guidance from TGL's.

Administration of data for drug substance operations and preparation of trending reports for analysis

• Document and review production and monitoring activities for drug substance manufacturing
• Complete SAP transactions in a timely, accurate manner.
• Draft, review and revise cGMP documents (SOPs/SWis, batch records, protocols, change controls, reports and other manufacturing supporting documents).
• Ensure all data is completed timely and accurately in LIMS, Master, Change Request Forms, PCS and EM svstem.

Health, Safety, and Environment and maintenance of GMP environment

• Participate in keeping the production area and office areas in a tidy, GMP manner, following 5S guideline or equivalent and supply materials as required
• Disinfect area as required in SOP.
• Assist to ensure loading dock and hallways are clean and unobstructed by materials or equipment, garbage is discarded daily to designated area outside production.
• Use proper PPE when performing tasks.
• Follow HSE SOP's, identify and minimize risks, promote safety culture.
• Ensure chemicals are stored as per HSE requirement and has MSDS available.

Process improvement, development, and preparation of trending reports for SPC analysis

• Assist implementation of facility, equipment, and process improvement projects
• Assist in writing specifications, protocols and reports related to facility, equipment, and process improvement of production process
• Modification of SOPs and BPR's for new processes in accordance with change control policies
• Perform activities involved in IQ, OQ, and PQ for new equipment
• Initiate Deviations, CCR, CAPA in Quality system as needed and assist until completion as per committed due dates
• Collaborate with other departments for root cause analysis and assist with implementation of corrective actions

No employee has a proprietary right to an activity or group of activities. Activities may be changed or reassigned to meet the needs of the operations.   

About You 

​Minimum Qualifications: 

• Minimum 3  years College Diploma in Science or Engineering (Biochemistry, Microbiology, Bioengineering, Biotechnology, Chemistry, Chemical Engineering, Pharmaceutical Sciences, other Life Science or equivalent education), plus a minimum of 18 months of previous relevant work experience.
• Preferred 4 years Bachelor's degree in Science or Engineering (Biochemistry, Microbiology, Bioengineering, Biotechnology, Chemistry, Chemical Engineering, Pharmaceutical Sciences, other Life Science or equivalent education), plus a minimum of 12 months of previous relevant work experience.

Hours Of Work: 

• Inclusive from Monday to Friday 6:00AM - 2:00PM

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​This is subject to change at any time and it should not be construed as limiting the right of the company to make such a change to meet the requirements of the operation. 

Mandatory Application Requirement: Your Workday application form must be complete, and a copy of your resume MUST be attached in the Workday application form, at the time you submit your Workday application, otherwise your application will not be considered for this position.

Pay rate - $48.02 per hour

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.  

Applications received after the official close date will be reviewed on an individual basis.​ 

AI Usage 

"Artificial Intelligence” refers to any systems that use automated processes, including algorithms and machine learning, to analyze data and make predictions, inferences, decisions, or recommendations without direct human involvement. These systems may process personal information to identify patterns, improve services, or support decision-making. The Company may use Artificial Intelligence for purposes including, but not limited to, resume screening and hiring, scheduling interviews or meetings, conducting surveys, matching skills with potential job openings, interview scoring, ensuring compliance with regulations applicable to our industry, and activities related to performance evaluation. Information collected and processed by the Company’s Artificial Intelligence systems may include the personal information detailed above and calendar availability. It excludes the information collected and processed for monitoring purposes. You should contact Human Resources if you have a question or concern regarding your personal information. You can also contact Canada’s Privacy Officer via Sanofi’s data subject request portal,  Data Subject Rights Webform. The Data Subject Rights Webform can also be used to request access or correction of your personal information and file a complaint. 

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.

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