Senior Scientist, Biologics Process Analytical Method Development
About The Position
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.
Requirements
- 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.
Nice To Haves
- 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.
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.
Benefits
- medical, dental, vision insurance
- a 401(k) plan and company match
- short-term and long-term disability coverage
- basic life insurance
- a tuition reimbursement program
- paid volunteer time off
- company holidays
- well-being benefits
- up to 80 hours of sick time
- up to 120 hours of paid vacation
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
