Senior Scientist, Biologics Process Analytical Method Development
Takeda
Summary
The Senior Scientist, Biologics Process Analytical Method Development is responsible for leading in-process analytical method development for biologics programs. In this role, you will partner with Biologics Process Development, Analytical Development, Quality, and Stability teams to develop, transfer, and sustain high-throughput analytical methods that support process and product development. You will apply phase-appropriate approaches and Analytical Quality by Design principles, integrate automation where appropriate, and provide clear scientific input that supports process development decisions.
Job description
About the role
The Senior Scientist, Biologics Process Analytical Method Development is responsible for leading in-process analytical method development for biologics programs. In this role, you will partner with Biologics Process Development, Analytical Development, Quality, and Stability teams to develop, transfer, and sustain high-throughput analytical methods that support process and product development. You will apply phase-appropriate approaches and Analytical Quality by Design principles, integrate automation where appropriate, and provide clear scientific input that supports process development decisions.
How you will contribute
- Lead in-process analytical method development needs and serve as the main contact for biologics process development, and in-process testing teams.
- Develop, optimize, transfer, and sustain high-throughput, fit-for-purpose analytical methods for biologics development using phase-appropriate approaches and Analytical Quality by Design (AQbD) principles.
- Partner with Analytical Development, Quality, Compliance, and Stability teams to support method bridging, transfer, and an analytical results continuum for biologics programs.
- Support the transfer, training, implementation, and lifecycle management of methods in process development laboratories, including documentation and troubleshooting plans.
- Work with automation subject matter experts to validate and integrate laboratory automation platforms into process analytical methods.
- Serve as a scientific resource and trainer for analytical and automation technologies, including support for new team members and interns.
- Evaluate new tools, platforms, and vendor solutions for laboratory automation and analytics as needed.
What you bring to Takeda
- Ph.D. MSc. or BSc. in analytical chemistry, chemistry, biochemistry, or related field with typical of 3 years (Ph.D.) 6 years (MS) or 11 years (BS) of relevant industry experience.
- Proven experience leading and managing programs, preferably in process analytical development functions.
- Strong expertise in developing chromatographic (U/HPLC), electrophoretic and isoelectric focusing (CE-SDS/Maurice®/Lab Chip GXII®) and/or ELISA type assays.
- Experience in development, phase-appropriate validation, transfer and life cycle management of analytical methods using AQbD principles.
- Knowledge on ICH and other regulatory guidance on analytical method development and life cycle management.
- Must have effective communication skills, including verbal, written, and scientific data presentation.
- Experience with laboratory automation capabilities, such as liquid handlers, dispensers, SCARA robots, and mobile robots, is highly desirable.
- Experience with laboratory information management systems and other digital or AI tools is desirable.
Requirements
- Ph.D., MSc., or BSc. in analytical chemistry, chemistry, biochemistry, or related field
- 3 years (Ph.D.), 6 years (MS), or 11 years (BS) of relevant industry experience
- Proven experience leading and managing programs, preferably in process analytical development functions
- Strong expertise in developing chromatographic (U/HPLC), electrophoretic and isoelectric focusing (CE-SDS/Maurice®/Lab Chip GXII®) and/or ELISA type assays
- Experience in development, phase-appropriate validation, transfer and life cycle management of analytical methods using AQbD principles
- Knowledge on ICH and other regulatory guidance on analytical method development and life cycle management
- Must have effective communication skills, including verbal, written, and scientific data presentation
- Experience with laboratory automation capabilities, such as liquid handlers, dispensers, SCARA robots, and mobile robots, is highly desirable
- Experience with laboratory information management systems and other digital or AI tools is desirable
Company overview
Takeda Pharmaceutical Company Limited is a Japanese multinational pharmaceutical company founded in 1781 and incorporated in 1925. As one of the world's top 20 largest pharmaceutical companies by revenue and the third largest in Asia, Takeda specializes in developing and commercializing innovative medicines across several therapeutic areas including oncology, rare diseases, neuroscience, gastroenterology, plasma-derived therapies, and vaccines. With approximately 49,095 employees globally, the company operates research and development centers, manufacturing facilities, and commercial operations across 39 U.S. states and numerous countries worldwide. Takeda maintains dual headquarters in Tokyo and Osaka, Japan, with significant operations in Cambridge, Massachusetts, where it serves as the largest life sciences employer in the state. The company's patient-focused approach is guided by its Takeda-ism values of Integrity, Fairness, Honesty, and Perseverance, emphasizing a commitment to delivering life-transforming treatments while advancing sustainable healthcare solutions. Takeda's extensive portfolio includes both innovative biologics and small molecule drugs, supported by strategic acquisitions and partnerships that have expanded its capabilities in areas such as immuno-oncology and rare disease treatments.