More than 30,000 Takeda employees working in more than 70 countries are committed to improving quality of life for patients, who remain at the center of everything we do. Takeda Pharmaceutical Company Limited is a global, research and development-driven organization working internally and with external partners to translate science into life-changing medicines. Takeda focuses on the core therapeutic areas of oncology, gastroenterology, central nervous system and providing vaccines that address the most important infectious diseases. Novel products, especially in oncology and gastroenterology, as well as our presence in emerging markets, fuel our growth.
While Takeda is enjoying tremendous growth as an emerging global leader in the pharmaceutical industry, we remain ever mindful of our commitment to serve people worldwide by striving toward better health through leading innovation in medicine. In short, we are a passionate team doing important work that impacts patients lives. If you are driven to create better health and a brighter future, join us!
- Responsible for leading and managing complex projects of diverse scope within QC and cross-functionally.
- Independently exercises judgment for broadly defined practices, procedures and policies to select methods, techniques and evaluation criterion.
- Uses judgment and experience to troubleshoot problems and formulate solutions.
- Responsible for authoring CMC sections of regulatory submissions, providing responses to questions from Health Authorities.
- Represent QC business processes and needs within the department and at cross functional forums as a technical expert.
- Demonstrates an in-depth theoretical understanding of laboratory operations, systems, methods and regulatory compliance.
- Demonstrates an understanding of company priorities, objectives and project timelines. This includes understanding how QC activities affect the business.
- Applies scientific judgment to perform investigations of Out of Spec (OOS) and Atypical results. Works with external service providers on the timely resolution of deviations.
- Collaborates with Regulatory Affairs on preparation of submission documents, responses to questions from Health Authorities, and updates on stability and batch analysis data.
- Supports and oversees testing for process validation activities, as applicable.
- Works with analysts and employees from other departments to troubleshoot problems of broad scope that encompass multi-faceted projects.
- Reviews SOPs, studies, validation documentation, change controls and investigations to maintain compliance.
- Demonstrates an understanding of how analytical method performance impacts the business.
- Applies knowledge of cGMPs on a daily basis. Ensures that complete, accurate and valid quality testing documentation is received by Takeda.
- Meets with functional group on a regular basis to discuss, individual projects and departmental goals.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
Bachelors Degree in any Life Sciences with relevant laboratory coursework and 8+ years of relevant experience or Master s Degree in any Life Sciences with relevant laboratory coursework and 6+ years of relevant experience.
- Previous industry experience in a regulated environment highly desired.
- Ability to handle multiple tasks concurrently, and in a timely fashion.
- Must have basic understanding of laboratory instrumentation.
- Must be able to communicate effectively with supervisors and peers.
- Must be able to read, write and converse in English.
- Must be computer literate. Able to navigate, conduct searches, and complete online forms on Personal Computer for the purposes of training, performance management, and self service applications.
- Good interpersonal skills and be able to work effectively and efficiently in a team environment.
- Knowledge of cGMP manufacturing preferred.
- Knowledge of basic chemical and biological safety procedures.
- Must display eagerness to learn and continuously improve.
- Must have the following personal attributes: integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage and conviction.
- Position requires primarily a sedentary work.
- Willingness to travel to various meetings or training, this could include overnight trips.
- Requires approximately 15% travel.
we are driven to improve people's lives
Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visithttp://www.takeda.us/careers/EEO_Policy_Statement.aspx
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