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CMC Tech Writer
Yoh, A Day & Zimmermann CompanyVaughan, OntarioClaims Adjuster
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Yoh, A Day & Zimmermann CompanyVaughan, OntarioPrimary Duties : The vision of vaccine CMC Development & Supply (VCDS) is to be the best in class in R&D and to contribute to the timely delivery of quality clinical trial materials for new vaccine candidates. Sanofi takes pride in a world where no one suffers or dies from a vaccine-preventable disease and contributes to chasing the miracle of science. To work towards this vision, VCDS' mission is to develop manufacturing processes to provide quality material for pre-clinical and clinical experimentation. This involves developing manufacturing processes by relying on scientific and technological innovations while integrating international pharmaceutical requirements and investing in quality by design. VCDS is one of Canada's few biopharmaceuticals R&D groups to host a fully equipped process development and cGMP facility, supporting clinical research and testing of those materials for quality release. Together, Vaccine CMC Development & Supply (VCDS) employees work to prepare, test, and deliver vaccines and documentation for pre-clinical and clinical studies according to project timelines and the best international quality standards.
Responsibilities include but are not limited to :
- Manage, plan, develop, and coordinate CMC (Bioprocess Development & Manufacturing) portions of the Module 3 Regulatory submissions, i.e., Investigational New
- Drug (IND) submissions and Clinical Trial Applications (CTA). Manage, plan, develop, and coordinate CMC strategic and technical documents for R&D projects.
- Continuous process improvement of preparing Module 3 CMC submissions, project strategies, and technical documents related to Bioprocess Development and Manufacturing activities. Project-related meetings and provide input on regulatory submissions and technical documentation.
- Work in alignment with partners and other CMC members to ensure appropriate data is available for inclusion in the documentation.
- Work within the policies, procedures, and regulations as required by the Company and under the Occupational Health & Safety Act.
Key Sk ills, Abilities, and Competencies :
Estimated Min Rate : $40.00
Estimated Max Rate : $48.00
Note : Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Visit to contact us if you are an individual with a disability and require accommodation in the application process.
For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.