Lead Process Engineer - 1st Shift

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 Process Engineer role will make an impact:

Key responsibilities for this role include:

• Lead development of multiple transdermal projects including intermediates and drug products, transdermal components and Medical Products Division customer and proprietary projects such as wound care devices.

• Prepare overall project plans for all project activities, including customer interaction, R&D, Formulation and laboratory testing, manufacturing and regulatory submissions. Elicit and share information among interacting departments, maintains individual project detail as well as overall project status and motivates all aspects of the project.

• Lead planning and direct execution of experimental trials with appropriate statistical designs. This includes drafting protocols, working on-line with production personnel and writing summary reports. Plan and direct execution of clinical and validation lots. This includes writing protocols and batch records, overseeing manufacturing, data analysis and summary of results.

• Research, recommend and evaluate raw materials, including drafting specifications, evaluating vendors and developing test methods as appropriate.

• Propose and specify equipment for new processes as required.

• Lead training inter and intra-departmental personnel in equipment and process functions.

• Supervise personnel, inter and intra-department, as required and if necessary, by project.

• Provide technical support to regulatory staff during preparation of DMF submissions (for components) and NDA/ANDA submissions (for drug products).

• Ensure that all project aspects are properly documented. This includes the use of laboratory notebooks, meeting summaries, project status reports, protocols and reports.

• Provide technical support to Pharmaceutical and MPD manufacturing regarding equipment, materials, development and customer communications. Lead process problem solving. Provide technical support to regulatory and management staff for changes and improvements to submitted and commercial transdermal products.

• Develop in-process tests as necessary.

The minimum qualifications for this role are:

• Minimum of a Bachelor's degree (or equivalent) and 7-10 years of experience. However, a combination of experience and/or education will be taken into consideration.

• Must possess knowledge of writing concise and accurate reports. Ability to supervise and work well with others.

• Must possess good communication, time management and organizational skills. Must possess competent computer skills including Microsoft Word, Excel, PowerPoint, Lotus Notes, statistical software and project tracking software.

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.