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San Antonio, Texas, USA, United States of America
Onsite
Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases.
We have been included on number of award lists that demonstrate the impact we are making.
Every day, we rise to the challenge to make a difference and here’s how the Senior Research Scientist role will make an impact:
Key responsibilities for this role include:
Make laboratory batches to support early product development work. Conduct procedures in compliance with established protocols, DEA, cGMP and regulatory guidelines. Maintain a clean and safe environment.
Plan, design, execute and complete projects; providing imaginative and thorough solutions to a wide range of difficult assignments.
Contribute new ideas/concepts and to present research results to internal and external professionals. Maintain a level of scientific knowledge in assigned area; perform scientific literature searches and evaluations as required and understand/comply with accepted laboratory and safety procedures as well as ensure regulatory compliance. Provide technical expertise and guidance to project teams as the formulation and process subject matter expert.
Write manufacturing process instructions for execution at the Plant that follow cGMP requirements. Watch and support the manufacturing of batches at the Plant from R&D stage through Process Validation.
Write, review and edit technical documents such as SOPs (Standard Operation Procedures), SMAs (Standard Method Analysis) and TRs (Technical Reports).
Understand and apply current technology and evaluate related investigations and information from the literature.
Presents results and be responsible for projects involving considerable research. Recognizes work that can be distinguished for its intellectual properties.
Work closely with internal and external departments to ensure the efficient progress of projects.
Support site quality regarding product investigations, change controls, and CAPAs in a timely manner.
Expertise with MS Office. Possess and train others in use of advanced or specialized scientific software. Evaluates and recommends acquisition of new hardware and software for use at DPT.
Mentor and promote the technical and professional development of direct reports. Supervise the formulation development efforts and scale up timelines of projects.
Review and approve project protocols. Ensure estimated labor requirements are current and sufficient to complete project scope.
Review and approve compounding modules and process instructions for batch manufacturing at the plant.
Author documents for Regulatory submissions.
Within area of responsibility, understand and comply with all safety, environmental and quality practices and procedures as outlined in organizational/departmental guidelines and SOPs as well as applicable federal, state and local regulations. Perform other duties as assigned.
Perform other duties as assigned.
The minimum qualifications for this role are:
Minimum 4 - 6 years of related experience is required for Ph.D., <OR> 7 - 9 years for Master’s degree, <OR> 10 - 12 years for Bachelor’s degree. Experience in pharmaceutical product or process development is required. Knowledge in pharmaceutical drug development in semi-solids dosage forms and/or new drug delivery systems is a must. Strong knowledge of regulatory requirements and cGMPs is a must.
Must be able to organize and prioritize work in order to accomplish tasks assigned.
Ability to develop advanced research protocols, present findings and analyze, evaluate and interpret data.
Strong proficiency in computer, writing reports, laboratory, analytical, and organizational skills.
Must have excellent communication skills, a demonstrated ability to work with diverse teams and manage multiple projects within aggressive timelines. Ability to interact with personnel at all levels in department.
Strong technical and leadership skills, organizational and communication skills.
Strong knowledge of regulatory requirements and cGMPs is a must.
Must have the ability to coordinate and prioritize multiple projects in a fast-paced environment.
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.