About the Company
Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. With a commitment to science and a focus on transforming patients’ lives, BMS is a leader in oncology, immunology, cardiovascular, and fibrosis. Join a team dedicated to making a difference in healthcare.
Job Description
We are seeking a highly motivated and detail-oriented Drug Safety Chemist with a strong focus on Regulatory Affairs to join our dynamic team. In this hybrid role, you will be instrumental in ensuring the safety and compliance of our pharmaceutical products by applying your expertise in chemistry and regulatory guidelines. This position offers Work From Home (WFH) options, allowing for flexibility while maintaining collaborative engagement with our New Port Richey site.
Key Responsibilities
- Conduct chemical safety assessments for new and existing pharmaceutical compounds, identifying potential hazards and risks.
- Review and interpret analytical data, stability studies, and chemical properties relevant to drug safety.
- Prepare and review regulatory submissions (e.g., INDs, NDAs, MAAs) focusing on the chemical aspects of drug safety data.
- Collaborate with cross-functional teams including R&D, Clinical Operations, and Regulatory Affairs to ensure comprehensive safety evaluations.
- Maintain up-to-date knowledge of global drug safety regulations, ICH guidelines, and chemical safety best practices.
- Respond to regulatory agency inquiries regarding the chemical safety profile of products.
- Develop and implement robust strategies for the chemical evaluation components of pharmacovigilance.
Required Skills
- Strong understanding of organic and analytical chemistry principles.
- Proficiency in interpreting chemical structures, reaction mechanisms, and degradation pathways.
- Familiarity with global drug safety regulations (e.g., FDA, EMA) and ICH guidelines.
- Excellent written and verbal communication skills for preparing scientific reports and regulatory documents.
- Proven ability to work independently and collaboratively in a fast-paced environment.
- Strong analytical and problem-solving capabilities.
Preferred Qualifications
- Experience with toxicology and pharmacology principles.
- Familiarity with drug development processes from discovery to post-market surveillance.
- Experience utilizing safety databases and data visualization tools.
- Advanced degree (M.S. or Ph.D.) in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field.
Perks & Benefits
- Comprehensive health, dental, and vision insurance.
- Generous paid time off and holidays.
- 401(k) retirement plan with company match.
- Tuition reimbursement and professional development opportunities.
- Employee wellness programs and on-site fitness centers (where applicable).
- Flexible work arrangements, including Work From Home options.
- Opportunity to work on cutting-edge therapies that impact millions of lives.
How to Apply
If you are interested in this position, please click the "Apply Now" button below. To ensure your application is properly considered, please prepare the following:
- An up-to-date Resume or CV
- A brief cover letter summarizing your experience and motivation
Applications are reviewed on a rolling basis. Only shortlisted candidates will be contacted for an interview.
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