Lead Scientist

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 Lead Scientist role will make an impact:

Lead Scientist position will provide senior level scientific development and validation support for quantitative pharmacokinetics and immunogenicity assays to support studies conducted within the Bioanalytical Laboratory.

Key responsibilities for this role include:

Working in the Bioanalytical Laboratory at our world-class Research and Development Center with access to a broad suite of cutting-edge instrumentation, the incumbent will:

• Develop and validate analytical methods for the quantitation of small and large molecule drugs and metabolites (including peptides, proteins/antibodies, oligonucleotides and gene therapies) in biological matrix such as plasma, serum and tissues using LC-MS/MS, or hybrid immunoprecipitation LC-MS/MS technologies, in support of both pre-clinical and clinical studies that are compliant with the applicable regulatory guidance's.

• Manage Scientists and other laboratory personnel in the performance of method development and validation experiments within the Bioanalytical Laboratory, as assigned.

• Serve as a scientific leader in designing, performing and evaluating new methodologies, and in training/coaching junior level scientists/associates.

• Evaluate, summarize and present analytical results and progress to Bioanalytical Laboratory management and clinical program teams as required for specific methods and drug product programs.

• Serve as a bioanalytical subject matter expert (SME) to clinical operations program teams.

• Document laboratory activity in accordance with established procedures.

• Write, review and approve Bioanalytical Laboratory reports.

• Assist in troubleshooting analytical problems encountered during study sample analysis within the Bioanalytical Laboratory.

• Serve as a scientific/technical information resource for junior laboratory staff.

• Review data and associated documentation for scientific soundness and compliance with Standard Operating Procedures and regulatory guidelines.

• Write, review, and approve analytical methods and standard operating procedures within the Bioanalytical Laboratory.

• Present scientific work within and across functions, and in professional symposia/conferences.

The Preferred qualifications for this role are:

• A Doctorate and 6 years of experience, a master's and 8 years of experience or a bachelor's degree and 10 years of experience preferred. However, a combination of experience and/or education will be taken into consideration.

• Must possess in-depth knowledge of laboratory analytical theories, techniques and instrumentation employed in the quantitation/analysis of drugs and metabolites such as HPLC, triple quadrupole and high-resolution mass spectrometry, and automated sample processing equipment. A capability of using other types of analytical instruments (e.g., ELISA/MSD, qPCR, flow cytometry, etc.) would be a plus.

• Must have extensive hands-on experience in developing and validating LC-MS/MS based bioanalytical assays.

• Must be a team player, and possess excellent communication (oral and written), analytical and organizational skills. Experience and skill set in team management are highly desired.

• Must be able to multi-task and drive multiple projects and assigned responsibilities.

• Must possess the ability to write comprehensive technical reports and communicate complex concepts to colleagues across functions.

• A general understanding of current regulatory policies applicable to pharmaceutical industry practice and health authority regulations and expectations.

• Proficiency in speaking, comprehending, reading, and writing English is required.

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.