Senior Lead Scientist jobs in United States
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Viatris · 22 hours ago

Senior Lead Scientist

Viatris is a global healthcare company committed to empowering people to live healthier lives. The Senior Lead Scientist will be responsible for evaluating API suppliers, conducting analytical testing, and leading method transfer processes while ensuring compliance with industry standards.

BiotechnologyHealthcarePharmaceuticalLife ScienceHealth Care

Responsibilities

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

Qualification

Analytical Method ValidationAnalytical ChemistryAPI SourcingData AnalysisRegulatory ComplianceCross-functional TeamworkMicrosoft OfficeCommunication SkillsProblem Solving

Required

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
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

Benefits

Competitive salaries
Benefits
Inclusive environment

Company

Viatris is a global pharmaceutical company formed in 2020 through the combination of Mylan and Upjohn, a legacy division of Pfizer.

Funding

Current Stage
Public Company
Total Funding
unknown
2020-11-17IPO

Leadership Team

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Scott A. Smith
Chief Executive Officer
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Doretta Mistras
Chief Financial Officer
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Company data provided by crunchbase