- Microsoft Access
- Writing skills
- Statistical software
- Microsoft Excel
- Computer skills
5100 Mylan Technologies, 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 (Engineer, Stability) role will make an impact:
Key responsibilities for this role include:
Operate as stability subject matter expert within technical services group and primary liaison for other departments and project leaders regarding stability submission requirements for new products, deficiency responses, post-approval changes, and related recommendations.
Lead in the preparation of marketed product stability annual reports for inclusion in ANDA, NDA, and IND, pre and post-approval submissions to regulatory agencies. Annual report support will include aiding with the Continued Process Verification (CPV) Program with support from other Technical Services Team members.
Perform statistical analysis of historical stability data. Make recommendations for expiry date extensions or reductions, and establishment of control limits and/or internal release limits (thresholds) for intermediate and finished product release.
Develop and manage an emerging data process that will provide timely communication of stability data to other departments and project leads to ensure trends and any potential concerns are recognized and appropriately documented.
Serve as primary stability point person in the evaluation of aberrant test results during Trackwise laboratory and manufacturing investigations on stability data. Determining efficient and effective approaches/strategies (i.e. bracketing and matrixing) for investigation/project needs. Provide written stability assessments, summary reports and/or recommendations and call meetings as needed to discuss findings.
Represent stability systems during inspections and audits related to stability data; interact directly with inspectors as needed.
Possess expertise in stability regulations and guidance document requirements as it relates to stability and maintain awareness of proposed revisions and industry trends as they become available. Propose changes as needed to ensure MTI stability program remains consistent with regulatory and industry standards, particularly in regard to data evaluation and required stability data needs to support marketed products, product improvements, and associated regulatory filings.
The minimum qualifications for this role are:
Minimum of a Bachelor's degree in Mathematics/Engineering (or equivalent) and 3 years of experience. Prefer 7+ years of relevant experience in a Pharmaceutical cGMP environment. However, a combination of experience and/or education will be taken into consideration.
Must possess the ability to think critically, have troubleshooting skills and have solid communication and report writing skills.
Knowledge of and/or experience in routine laboratory/analytical testing and stability testing is desired but not required.
Knowledge of ICH and applicable regulatory guidance in regard to stability data preferred.
Knowledge of Pharmaceutical cGMPs.
Must possess computer skills and knowledge of Microsoft Excel, Word, Access, PowerPoint, and Outlook. Preference given to knowledge of statistical software programs (MiniTab).
Ability to read and interpret complex business and/or technical documents. Ability to write comprehensive reports and detailed business correspondence. Ability to work with managers or directors and communicate complex concepts. Ability to present to groups across the organization.
Ability to apply technical mathematical concepts and perform somewhat complex computations including regression analysis and statistics.
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 stand; walk; stoop; bend; kneel; and climb steps. May require use of hands and use of arms. Light lifting requirements.
Normal office situation. Work alone or closely with others. Ability and willingness to work to tight timelines.
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.