Manager, Toxicology
About this role
- Conduct literature searches and author expert reports, scientific position papers, safety and toxicological risk assessments (TRA) for pharmaceuticals, extractables and leachables (E&L), excipients, impurities and other chemicals.
- Establish health-based exposure limits (e.g., PDE, OEL) for manufacturing plants.
- Perform in silico (Q)SAR evaluations for mutagenicity, irritation, sensitization; derive acceptable intake limits and justify higher impurity levels using alternate toxico-regulatory approaches.
- Conduct n-nitrosamines/NDSRI safety assessments.
- Explore and implement novel alternative methodologies to replace traditional toxicology/PK/PD studies using appropriate systems.
- Provide nonclinical support for integrated product development, including NDA 505(b)(2) andA applications and complex generics across injectable, ophthalmic, inhalation, oral and topical products.
- Design, organize, monitor and resolve issues for outsourced preclinical toxicology, pharmacokinetics (PK), pharmacology and tissue distribution studies with external CROs.
- Plan, outsource, monitor and interpret Enhanced Ames Test (EAT) and other in vitro and in vivo mutagenicity studies at external CROs.
- Collaborate proactively within global cross-functional teams (Regulatory Affairs, Analytical R&D, Formulation R&D, Project Management, Clinical, Quality, Manufacturing).
- Ensure scientific integrity and animal welfare in all activities.
- Maintain technical and professional expertise by staying current with industry developments and sharing knowledge internally.
- Demonstrate sound understanding of Good Laboratory Practice (GLP) regulations.
- Use of AI for improved efficiency in routine work
Additional Responsibilities:
Company at a glance
Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) is guided by a simple belief: essential medicines should be accessible to everyone. What began as a promise to deliver high-quality, affordable medicines has evolved into a diversified portfolio spanning complex generics and injectables, biosimilars, and specialty medicines, including more than 290 products, with scale and capabilities that help reach patients across the healthcare system while combining world-class precision with a deep sense of personal responsibility for every dose we deliver.
Content is for informational purposes only and 3rd party content does not reflect Amneal’s opinions.
Amneal has the right to remove comments that violate another’s copyright or intellectual property, mention an Amneal product, use profanity or are defamatory, promote and solicit for third-party sites, initiatives, or products, or are factually inaccurate or misleading or spam.
Amneal recommends that you consult with your healthcare provider regarding personal health matters. To report a product complaint or adverse event related to an Amneal product, contact Drug Safety at 877-835-5472, option 3 or [email protected]. If you are currently experiencing a life-threatening event, please immediately contact 911.
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