ViatrisSenior Lead Scientist
Mylan Pharmaceuticals 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 Senior Lead Scientist role will make an impact:
Key responsibilities for this role include:
Overall assessments of alternate API suppliers for commercial products by working with R&D API sourcing team and other related groups to support commercial products manufacture.
Possess knowledge/skill to discuss and/or perform analytical testing on a range of API sourcing samples using a variety of testing methods and techniques including NMR, HPLC, LC-MS/MS, GC, DSC, TGA, CD, UV, and IR spectroscopy.
Critically evaluate and audit data.
Write API sourcing reports for alternative supplier source selection.
Interface with CMOs and cross-functional teams to define analytical method transfer strategy and provide routine project updates.
Lead and coordinate the end-to-end process of transferring analytical methods across external sites.
Develop and support analytical method transfer and execution, including providing method transfer materials, preparing AMT protocol, report and auditing AMT results across Donor and Recipient sites.
Lead and participate in scientific investigations and trouble-shoot process issues that arise during analytical transfer, or scale-up.
Work with Human Relations in interviewing, performing employee appraisals, directing disciplinary actions, and resolving employee issues.
Serve as department representative internally to other departments or subsidiaries and externally to third-party laboratories, manufacturers, and/or regulatory agencies.
Act as a scientific resource for the Company.
The minimum qualifications for this role are:
Minimum of a Bachelor's degree (or equivalent) and 6-10 years of experience. A Master's degree (or equivalent) and 4 years of experience or a Doctorate (or equivalent) preferred. However, a combination of experience and/or education will be taken into consideration.
Must possess knowledge of the wide variety of analytical methods common to the pharmaceutical industry, industry practices, and health authority regulations and guidances.
Must possess strong analytical chemistry background including familiarity with the wide variety of methods common to the pharmaceutical industry.
Subject matter expert (SME) for Analytical Method Validation and transfer
Must maintain comprehensive and meticulous records of experimental protocols, results, and data analyses, ensuring data integrity and compliance with all EH&S and regulatory standards. Must possess strong communication and reading skills. Basic working knowledge of Microsoft Office. Must be able to effectively operate a computer-based data acquisition system for chromatography. Must be able to multi-task to work on multiple projects at the same time.
Subject matter expert (SME) for Analytical Method Validation and transfer.
Ability to work effectively in a cross-functional team environment.
Process experience in drug substances and drug products.
Ability to read and interpret complex business and/or technical documents. Ability to write comprehensive reports and detailed business correspondence. Ability to work with groups of people such as other departments and communicate known concepts. Ability to present to a group of departments.
Ability to solve equations, apply technical mathematical concepts, and perform complex computations.
Ability to solve problems with a variety of concrete variables through semi-standardized solutions that require some ingenuity and analysis. Ability to draw inferences and follow prescribed and detailed procedures to solve moderately complex problems.
Typically sitting at a desk or table. Intermittently sitting, standing, walking, or stooping. May be required to bend; kneel; and climb steps. May require use of hands and use of arms. Sedentary lifting requirements.
Normal office and chemical laboratory situation.
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.