Senior Scientist, Biologics Process Analytical Method Development

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.

Responsibilities

• 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.

Requirements

• Ph.D., MSc., or BSc. in analytical chemistry, chemistry, biochemistry, or related field with minimum of 3 years (Ph.D.), 6 years (MSc.), or 11 years (BSc.) 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.
• 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.

Qualifications

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.