Viatris Canonsburg PA United States
2 months ago
1000 Mylan Inc.
At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs...
Viatris empowers people worldwide to live healthier at every stage of life.
We do so via:
• Access - Providing high quality trusted medicines regardless of geography or circumstance;
• Leadership - Advancing sustainable operations and innovative solutions to improve patient health; and
• Partnership - Leveraging our collective expertise to connect people to products and services.
Every day, we rise to the challenge to make a difference and here's how the Pharmacologist/Toxicologist role will make an impact:
Key responsibilities for this role include:
• Serves as Scientist in Global Pharmacology and Toxicology for developmental programs for Complex products/Injectable/OSD drug products or as needed based on Company's strategies.
• Work with the Pharma/Tox team to develop optimal strategies to address specific safety issues and partner with the project team to select and advance development of compounds.
• Designing, planning and overseeing the conduct of pharmacology, safety pharmacology and toxicology studies at external CROS.
• Assists in the selection and approval of contract testing facilities used for nonclinical studies.
• Provide input during protocol development, and to ensure appropriate timely initiation, overseeing the conducti of studies progression, and completion of studies per projects timelines.
• Ensuring data quality and integrity from preclinical sites. Critically analyze data, interpret data and communicate the results and conclusions to the project teams.
• Understand and provide support in the research and construction of regulatory study documents, technical scientific analyses and positional papers (i.e., IND/NDA and other regulatory documents).
• Understand and perform toxicological risk assessments for various health-based exposure limits (HBELs), such as ADEs, PDEs, ADIs, OELs, etc. Perform environmental risk assessments (ERAs) and oversee the conduction of environmental studies to support such assessments.
• Understand and assist in resolving impurity, degradant and device-related qualification issues including the assessment of extractables and leachables and ICH M7-compliant genotoxicity evaluations.
• Comprehension of relevant Viatris Standard Operating Procedures (SOPs) and compliance with Laboratory SOPs and other relevant policies.
The minimum qualifications for this role are:
• Candidates must possess an earned doctoral degree in Toxicology, Pharmacology or related field and 2+ years of experience in toxicology and pharmacology from pharmaceutical/biotech industries, or an earned master's degree in an appropriate field with at least 6+ years of full-time professional post-baccalaureate experience (or part-time equivalent thereof) in toxicology and pharmacology, or must possess an earned bachelor's degree in an appropriate field and have at least 8+ years professional post-baccalaureate experience (or part-time equivalent thereof) in toxicology/pharmacology.
• Must possess knowledge of the biological impact of drug product materials (APIs, excipients, impurities, etc.) in the human body.
• Some knowledge of applicable world health authorities' regulations, standards and guidelines covering drug development is essential. The knowledge and application of GLP and ISO/ICH/OECD regulations is required.
• Must possess effective oral and written communication, organizational and computer skills. Must be able to interact with a diverse workgroup in a team-oriented environment with the ability to communicate performance expectations in a clear and concise manner.
• Must have experience in toxicology/pharmacology, familiarity with pharmaceuticals as well as experience in determination of health-based exposure limits.
• Ability to read and interpret comprehensive and intricate research documents. Ability to write scientific reports and technical correspondence. Ability to work and communicate abstract concepts. Ability to present to a high level of the organization and groups outside of the organization.
• Ability to solve equations, apply technical mathematical concepts, and perform complex computations.
• Ability to solve problems with complex variables through non-standardized solutions that require independent judgment and analysis. Ability to draw inferences and use deductive reasoning with no prescribed procedures to solve complex problems.
• Typically sitting at a desk or table. Intermittently sitting, standing, walking or stooping. May be required to stand; walk; stoop; bend; kneel; and climb steps. May require use of hands and use of arms. Sedentary lifting requirements. Periodic travel is required.
• Normal office situation.
• Proficiency in speaking, comprehending, reading and writing English is required.
Exact compensation may vary based on skills, experience, and location. The salary range for this position is: $77,000.00 - $148,000.00 USD.
At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.
Viatris is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, gender expression, disability, or protected veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations.
Mylan offers competitive salary, excellent benefits and an environment conducive to professional growth and advancement. All qualified applicants will receive consideration for employment without regard to their disability or protected veteran status. Mylan is an Equal Opportunity Employer, Minorities/Female/Disabled/Veteran.Â
Canonsburg PA USA
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