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Scientific Impurities Specialist
3 months ago
As a Scientific Impurities Specialist at Pharmascience, you will play a pivotal role in steering interdisciplinary teams to formulate and implement strategies aimed at managing nitrosamine impurities in our pharmaceutical products. Your expertise will be crucial in developing risk management frameworks and conducting thorough risk evaluations to ensure compliance with Health Authority standards while safeguarding the continuity of global product marketing and distribution.
KEY RESPONSIBILITIES:
- Conduct comprehensive risk evaluations for the manufacturing of active pharmaceutical ingredients (APIs), excipients, and finished products, focusing on the potential presence of nitrosamines and NDSRIs.
- Design and implement testing protocols for products identified as 'at risk'.
- Investigate the underlying causes of impurity formation in finished products and formulate risk mitigation strategies to achieve regulatory compliance.
- Collaborate with Toxicology teams to determine acceptable intake levels for nitrosamines, utilizing structure-activity relationships (SAR), read-across methodologies, and other regulatory frameworks.
- Coordinate analytical method development and validation for commercial products in partnership with Royalmount Laboratories and/or external testing facilities.
- Analyze findings and develop strategies for control, mitigation, or remediation efforts.
- Manage remediation initiatives with Global Operations Technical Services for impacted products.
- Work alongside Global Regulatory Affairs to maintain compliance for products marketed both locally and internationally.
- Partner with Procurement and Global Operations to oversee product lifecycle management and source modifications.
- Initiate and manage product Change Controls with raw material suppliers.
- Become a subject matter expert on nitrosamines.
- Stay updated on current literature and regulatory guidelines concerning nitrosamines.
REQUIRED SKILLS AND QUALIFICATIONS:
- Strong foundation in organic and analytical chemistry.
- Bilingual proficiency in French and English, with excellent written and spoken English for communication with international regulatory bodies and external stakeholders.
- Exceptional project management capabilities.
- Robust analytical, planning, and strategic thinking skills.
- Proven leadership abilities to effectively guide and influence teams.
- Outstanding interpersonal, organizational, and presentation skills.
- Strong communication skills with the ability to motivate others.
- Adept at working in an agile environment to provide clear direction and make informed, risk-based decisions.
- Knowledgeable in toxicological assessments.
- Experience as a change leader.
- Self-motivated, confident, and autonomous.
- Ability to prioritize and manage multiple projects concurrently within cross-functional teams.
- A minimum of 5 years of experience in the pharmaceutical manufacturing sector, with practical exposure to toxicology.
- PhD or higher in Chemistry or a related discipline.
