Senior Scientist

Job Description

The Manufacturing Science and Technology (MSAT) Scientist/ Senior Scientist is responsible for transferring viral vector bioprocesses into GMP production. These roles involve direct collaboration with clients and cross-functional teams to ensure process scalability and manufacturability. The Scientist or Senior Scientist oversees process integration, supervises manufacturing campaigns, leads major deviation investigations, and drives process improvements under the guidance of a Senior Scientist or Manager/ Director.

Key Responsibilities:

Transfer manufacturing processes by leveraging process flow diagrams, expertise, and transferred data under the supervision of senior MSAT Scientists or Management.

Support technology transfer of buffer/media production, cell culture, harvesting, purification, and bulk filling of drug substances and/ or sterile final drug products.

Execute process transfers from Lonza Process Development (PD) or external clients in compliance with GMP regulations.

Manage project timelines, identify risks, and escalate issues to project management, or MSAT leadership as needed.

Support new product introductions (NPI) and technology transfers, assist in troubleshooting manufacturing processes, and oversee operations to ensure consistency and accuracy.

Develop expertise in upstream or downstream processing and apply process analysis techniques to resolve deviations and improve overall manufacturing efficiency.

Participate in technology transfer, process oversight, and process improvements with minimal supervision.

Assist in creating a bill of materials, conducting material suitability assessments, and identifying alternative sources as needed.

Key Qualifications:

Bachelor's degree in a related scientific field.

5+ years of experience in bioprocessing or a related field.

Advanced knowledge of cellular biology, cell culture, bioreactor operation, mass transfer, filtration, chromatography, and aseptic processing.

Sterile processing and/ or sterile filling operational experience is desirable

Strong problem-solving and critical thinking skills.

Ability to communicate technical challenges and solutions effectively in both written and verbal formats.

Experience leading small projects and collaborating across departments.

Proficiency in root cause analysis (e.g., Five Why, Fishbone, DMAIC) and risk assessment methodologies (e.g., FMEA, HAZOP).

Attention to detail and a high level of accuracy.

Knowledge of statistical data analysis is a plus.

Full-time