Senior Scientist, Analytical Development, Bioassay Development, Biologics

Vertex Inc.•Boston, MA

1d•Onsite

About The Position

General Summary Vertex Biologics, Cell and Genetic Therapies is seeking a highly motivated Senior Scientist to join our Analytical Development team. The successful candidate will play a critical role in the development, optimization, and validation of bioassays to support characterization of biologics and other complex biologic modalities. This position requires a strong background in bioassay development, biologics, and cell line development, as well as a passion for innovation and collaboration in a fast-paced and dynamic environment. The position will be based in Boston, MA.

Requirements

Ph.D. degree in immunology, cell biology or biology-related scientific discipline and 3-5 years of work experience in biopharmaceutical industry or Master’s degree in biology-related scientific discipline and 5 years of work experience in biopharmaceutical industry or Bachelor’s degree in biology-related scientific discipline and 8 years of work experience in biopharmaceutical industry.
Must have prior hands-on experience developing and qualifying/validating bioassays for biologics in compliance with regulatory guidelines.
Strong background in cell line development for assay purposes.
Proven proficiency in ELISA, reporter gene assays, cytotoxicity/ADCC/CDC assays and other bioassay readout.
Familiarity with statistical tools and software for data analysis (e.g., JMP, GraphPad Prism, SoftMax Pro and other bioassay data analysis software).
Must be familiar with USP, FDA and ICH guidelines governing bioassay development and validation.
Demonstrated ability to multi-task as necessary, manage competing priorities and advance multiple projects within required timelines.
Strong problem-solving and critical-thinking abilities.
Attention to details.
Excellent written and verbal communication skills with the ability to present complex data to diverse audiences.
Demonstrated ability to work collaboratively in cross-functional teams.
Effective delivery of objectives within the preset timeline.
Proven leadership and mentoring skills.

Responsibilities

Bioassay Development: Design, develop, and optimize bioassays to support the characterization, potency, and stability testing of biologics.
Support tech transfer to external QC.
Perform troubleshooting and support analytical investigation.
Implement cutting-edge technologies and methodologies to enhance assay robustness and performance.
Cell Line Development: Manage CROs for the development of cell lines for use in bioassays.
Act as the primary point of contact to provide technical guidance and ensure alignment with project goals and timelines.
Troubleshoot and resolve technical challenges related to cell line development and maintenance.
Assay Validation: Lead the qualification and validation of bioassays in compliance with regulatory guidelines (e.g., USP, FDA, ICH).
Author and review technical reports, standard operating procedures (SOPs), and regulatory submission documents.
Data Analysis and Interpretation: Analyze experimental data using statistical tools and software to ensure accuracy and reliability.
Interpret results and provide scientific insights to guide decision-making in product development.
Collaboration and Cross-Functional Support: Collaborate with cross-functional teams, including Analytical Development, Process Development and Regulatory Affairs, to support the development of biologics.
Provide technical expertise and guidance to junior scientists and team members.
Innovation and Continuous Improvement: Stay current with advancements in bioassay technologies and industry trends.
Identify and implement innovative approaches to improve assay performance and efficiency.
Up to 10% travel is required for this role.