Analytical Development Scientist

Signature Biologics, as part of a suite of emerging biotechnology and research companies, focuses on the development and commercialization of regenerative-based products. We have significant clinical experience working with human perinatal biologics internationally and we are currently developing products in the US.

Essential Duties and Responsibilities:

• The Analytical Development Scientist within the Analytical Development department will participate in activities of development, tech transfer, optimization, qualification, and validation of analytical methods to support cell therapy manufacturing activities. This position plays a key role in demonstrating the values, culture, and deliverables of the site.
• Key Responsibilities:
• Acts as technical subject matter expert (SME) for the company, leading and participating in developing, transferring, and qualifying of cell therapy methods, including flow cytometry, ELISA, q-PCR/ddPCR, and/or cell-based assays.
• Writes and reviews Standard Operating Procedures (SOPs), test records, protocols, and associated reports as needed
• Maintains current awareness of GMP/GLP/GCP/GDP, ICH, USP, and FDA guidelines, industry standards, and trends that apply to current and future Cell Therapy Development operations and products.
• Assesses, supports, and implements new analytical technologies and fills the technical gaps within the company.
• Presents technical project status and data-driven updates to internal teams.
• Provides support in aspects of Laboratory Investigations, Deviations, CAPAs, Change Control, and Quality Records.

Education and/or Work Experience Requirements:

• BS/BA in Biological Science, Biochemical Engineering, or related life science required. Masters preferred.
• Minimum of 3-5 years experience of laboratory/manufacturing experience in Analytical Development. Direct cell therapy industry experience preferred.
• Demonstrated expertise in a range of analytical methods used in cell therapy, including flow cytometry, ELISA, q-PCR/ddPCR, and/or cell-based assays required.
• Attention to detail, problem-solving ability, and troubleshooting assays and instrumentation are required.
• Ability to effectively present information to top management, public groups, and/or regulatory authorities
• Excellent verbal and written communication skills with the ability to collaborate across multiple teams and projects.
• Ability to multi-task and prioritize responsibilities.
• Must be able to work under pressure and meet deadlines, while maintaining a positive attitude and providing exemplary work product.