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!
- Directs ,oversees the optimization, , large scale-up of Drug Product.
- Prepares process comparability reports
- Supports Takeda site where DP Tech transfer is currently happening. Leads activities to ensure a robust Drug Product manufacturing process to cover DP pipeline
- Provide professional information, input, and review as needed for USFDA and other non-US regulatory agency submissions.
- Design, test, transfer, and oversees unit operations for manufacture of Final Drug Product (FDP). Operations include, but are not limited to, complex aseptic formulation, solubilization and filter sterilization of hydrophobic compounds and aqueous solutions, continuous mixing, and fill finish into vials and/or prefilled syringes.
- Manage off-site CMO s for various aspects of FDP manufacturing including authoring and reviewing of Batch Records/Master Production Records specific to unit operations, reagent acquisition, raw material specifications, transfer of in-process analytical testing methods, and person-in-plant for GMP activities.
- Develop and test formulations to improve product stability, facilitate manufacturing processes, prolong shelf life, and set product specifications.
- Design and implement protocols for technical evaluation of product-related devices; e.g., bulk Drug Substance and FDP storage containers/contact surfaces and Drug Product delivery devices.
- Design and implement protocols for product stability studies, both long-term and accelerated.
- Coordinate product and process characterization studies off-site with various CMOs/CTOs and prepare reports for regulatory submissions.
- Author and review CMC documentation, including technical and quality sections, for submission to regulatory agencies; e.g., IND, CTD.
- Participate and, as applicable, make presentations in both internal and external technical reviews, including regulatory discussions.
- Other duties as needed.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- A PhD in Chemistry,Pharmaeutics, or Life sciences, or equivalent education.
- Minimum of 10 years experience in the pharmaceuticals, biologics, manufacturing
- At least 5 years experience in a GMP manufacturing environment.
- Thorough understanding of all aspects of the R&D process.
- Knowledge of GMPs and CMC regulatory requirements concerning drug development.
- Maintain in-depth knowledge of state-of-the-art principles and theories, applying such knowledge that supports the company s goals.
- Possess excellent verbal and written communication skills and interpersonal skills, together with highly developed motivational and organizational skills.
- Skillfully exercise independent judgment in developing methods, techniques, and evaluation criteria for obtaining results.
- Demonstrate technical proficiency, scientific creativity, collaboration with others, and independent thought in suggesting experimental design and research strategy.
- Think critically and creatively and effectively work independently and determine appropriate resources for resolution of problems.
- Effectively recognize anomalous and inconsistent results and interpret experimental outcomes.
- Effectively represent the pharmaceutical development function both internally and externally.
- Skilled in use of office software packages and scientific software applications.
- Exhibit and promote Takeda Core Competencies
- Willingness to travel to sites for DP tech transfer work. International travel may be required.
- Requires approximately 30% 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
No Phone Calls or Recruiters Please.