Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Research Investigator in our Cambridge, MA office.
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Futureto people around the world.
Here, you will be a vital contributor to our inspiring, bold mission.
- This is a laboratory-focused, experienced position within Biologics Drug Product Development.
- Provides theoretical/conceptual input to the design, development and execution of research assignments for a specific project or projects within the functional area (e.g., formulation screening by design of experiment, analyze data and create predictive models for protein stability).
- Independently plans and executes characterization and optimization experiments (protein conformation and chemical stability) within expertise and develops new screening tools (e.g., chromatography, protein particle analysis).
- Responsible for significant or sole technical leadership within project or complex study (e.g., design drug product manufacturing processes or protein formulation screening studies). Prepares technology transfer documentation and regulatory documents or coordinates with team members to ensure execution (e.g., author drug product manufacturing process documents, author regulatory filing documentation or section maybe required).
- Potentially represents line function on Global Chemistry Control (GCT) and Manufacturing Teams as appropriate/necessary (e.g., provide technical leadership or expertise on formulation development and drug product manufacturing).
- Laboratory-focused, conduct day to day laboratory experiments planning and execution.
- Understands drug product developmental project timelines and deliverables and plans/coordinates project work accordingly with departmental, functional and external stakeholders to support clinical studies and commercial.
- Provides technical leadership to drug product development project teams within area of expertise and commits resources to execute specific project tasks (e.g., protein formulation development and drug product manufacturing process)
- Contributes significantly and independently to drug product formulation development work which may include screening multiple proteins within functional area
- Reviews, interprets and communicates data cross-functionally teams (e.g., protein stability data, drug product manufacturing process data).
- Plans and implements resolutions to technical problems/issues
- Potentially represents functional area on GCTs by communicating activities from designated functional area to project team
- Independently designs and executes experiments, and reports results
- Assists with development of project strategy and communicates complex data/decisions within department and cross functionally as necessary
- Builds and maintains relationships with key vendors and assists with technical aspects of vendor negotiations
- Responsible for integrating scientific/technical efforts around cross-functional issues
EDUCATION,BEHAVIOURALCOMPETENCIES AND SKILLS:
Education and Experience:
- Bachelors degree in chemistry/biochemistry,biology,pharmacy, engineering or related pharmaceutical science and 6+ years relevant industry experience
- Masters degree in chemistry/biochemistry,biology,pharmacy, engineering or related pharmaceutical science; 4+ years relevant industry experience
KNOWLEDGE AND SKILLS
Strong laboratory skills. Protein formulation development experience preferred; Experience with analytical methods used for protein analysis such as HPLC, CE, spectroscopy, and sub-visible particle analysis; Knowledgeable about Design of Experiments and statistical principles for experimental design and data analysis; Exposure to the development of combination products and drug antibody conjugates preferred; Experience leading technology transfer to aseptic drug product manufacturers preferred
- Analytical and Problem Solving Skills - Able to troubleshoot critical issues or problems, and determine causes and possible solutions
- Teamwork -- Ability to work well in highly cross functional team environment and across global line functions.
- Communication Skills -Able to expresses one s self clearly and concisely within team; documents issues and/or concerns concisely with colleagues; adjusts communication style as appropriate for the audience; timely and effectively communicates issues to supervisor; technical writing skills to support authorship of internal technical documents
- Organization Exercises good time management and prioritization skills and is able to successfully manage multiple tasks simultaneously
- Knowledge Sharing - Ability to capture organizational knowledge; improve solutions, processes, and deliverables through use of information; improve information capital by contributing experience, theories, deliverables, and models for others to use
- Resource Management -Ability to manage one s time within individual, departmental, and corporate goals and timelines; management of internal and external resources (vendors)
- External Involvement Demonstrated involvement in professional community evidenced by presentation of scientific posters or lectures at professional conferences or events
- Technical - Subject matter expertise and knowledge of applicable lab equipment and operations
May require approximately 5-10% travel.