Reference Number: Position title: B100 DT Upstream Technologist
Duration: Fixed Term Contract - 3 years
Location: Toronto, ON
Main Responsibilities: Execution of Upstream activities of drug substance - Assist in review of Records, SOP, and logbooks for completion and ensure accuracy of all documents as per GMP guidelines.
- 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.
- Participate in IQ/OQ/PQ validation and cleaning verification protocols.
- Ensure all equipment, instruments and systems are properly assembled, installed, tested and maintained.
Preparation of inoculum, analytical testing, area monitoring (utility sampling, environmental monitoring), maintenance, material handling, warehouse- Perform activities and documentation involved in Upstream including, in buffer preparation, inoculation preparation, fermentation, harvest, FIM antigen related processing and material handling using MES/PCS system.
- 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.
- Ensure area is inspection ready.
Administration of data for drug substance operations and preparation of trending reports for SPC analysis- Document, review production and monitoring activities for cP & DT drug substance manufacturing
- Complete SAP transactions in a timely, accurate manner.
- Draft, review and revise various cGMP documents (SOPs/SWls, batch records, protocols, change controls, reports and other manufacturing supporting documents).
- Analyze, enter & verify data on paper based or electronic documents.
Health, Safety and Environment and maintenance of GMP environment- Participate in keeping the production area and office areas in a tidy, GMP manner, following SS 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 SDS available.
Participate in process improvement and equipment improvement, and Quality and Inspection readiness initiatives.- 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 Qualifications:- Minimum (3) three years College diploma (Biochemistry, Microbiology, Bioengineering, Biotechnology, Chemistry, Chemical Engineering, Pharmaceutical Sciences, other Life Science, or equivalent) plus a minimum of (2) two years of previous relevant work experience.
- Preferred (4) four years Bachelor's degree (Biochemistry, Microbiology, Bioengineering, Biotechnology, Chemistry, Chemical Engineering, Pharmaceutical Sciences, other Life Science, or equivalent) plus a minimum of 18 months of previous relevant work experience.
- Fermentation Process for cP bacteria, Production Equipment
Aseptic Technique - Current Good Manufacturing Practices (cGMPs)
- Knowledge and experience in Chemistry, Microbiology, Biochemistry
- Mathematics, Computer, Mechanical Aptitude, Technical Writing, Quality and Improvement, Safety
Hours Of Work:- Inclusive from Monday - Friday 2:00PM to 10:00PM
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 hourAI 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.
#GD-SP
#LI-SP
#LI-Onsite
