Senior Scientist, Biologics Process Analytical Method Development

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.

• 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.

• Ph.D. MSc. or BSc. in analytical chemistry, chemistry, biochemistry, or related field with minimum 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.

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

Lexington, MA

$ - $

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.

The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Lexington, MA

Employee

Regular

Full time

Yes

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.