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Pharmascience is seeking a highly skilled Scientific Specialist to drive cross-functional teams in developing and executing strategies to control nitrosamine impurities in commercial drug products. The ideal candidate will devise risk management approaches and perform risk assessments to ensure alignment with Health Authority regulations while maintaining global product marketing and distribution continuity.
Responsibilities:- Evaluate and prepare robust risk assessments for API manufacturing, excipients, and finished product manufacturing, packaging, and storage for the presence of nitrosamines and NDSRIs.
- Identify and develop testing strategies for 'at risk' products.
- Investigation of root causes for impurity formation in finished products and devise risk mitigation strategies to ensure acceptable levels are achieved and meets regulatory compliance.
- Collaborate with Toxicology teams to establish appropriate acceptable intake levels for nitrosamines based on SAR, read-across and other permissible regulatory design approaches.
- Prioritize and schedule analytical method development and validation activities for commercial products in collaboration with Royalmount Laboratories and/or third-party testing facilities.
- Review analytical findings and prepare strategies for control, mitigation or remediation activities.
- Prioritize and schedule remediation activities with Global Operations Technical Services for affected products.
- Collaborate with Global Regulatory Affairs to ensure the continued compliance of products marketed locally and internationally.
- Collaborate with Procurement and Global Operations to manage product life cycle site and source changes.
- Initiate and manage product Change Controls from raw material vendors.
- Become subject matter expert to assess all aspects of nitrosamines.
- Keep abreast of nitrosamine current literature and regulatory guidelines.
- Excellent background in organic and analytical chemistry.
- Bilingual French and English. Spoken and written fluency in English due to communication with international regulatory authorities and external partners.
- Strong project management skills.
- Strong analytical, planning and strategic thinking skills.
- Strong leadership skills to effectively lead and influence.
- Excellent interpersonal, organizational and presentation skills.
- Strong communication skills and the ability to encourage others.
- Work in agile mode to provide clear direction and make risk-based decisions.
- Knowledgeable in toxicology assessments.
- Experience as a change Leader.
- Autonomous, self-assured and self-motivated.
- Ability to prioritize and work multiple projects simultaneously with cross-functional teams.
- 5 years experience in the Pharmaceutical manufacturing field with practical experience in Toxicology.
- PhD or better in Chimie - Chemistry or related field.
