Job DescriptionGeneral Summary:Vertex is seeking a highly motivated Scientist to join the Analytical Development team. This role will lead the development of analytical cell lines that serve as critical reagents for potency assay development, functional characterization, and analytical control strategy. The Scientist will play a critical role in the development, optimization, and validation of bioassays to support characterization of biologics and other complex biologic modalities. Operating at the interface between Research and Analytical Development, the Scientist will translate product mechanism of action into scientifically sound, phase-appropriate cell line and assay strategies. This role 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, dynamic environment. The position will be based in Boston, MA.
Key Duties and Responsibilities:Cell Line Development:
- Lead the design, characterization and lifecycle management of stable mammalian analytical cell lines expressing targets of interest, receptor systems, or reporter constructs to support potency and functional bioassays.
- 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.
- Translate product mechanism of action into cell line designs and cell-based assay concepts aligned with potency and analytical control strategy.
Bioassay Development, Validation and Transfer:
- Develop and support cell-based bioassays, including reporter gene assays, signaling pathway assays, proliferation or cytotoxicity assays, and other mechanism-based functional readouts.
- Contribute to early-stage potency assay development and ensure effective technical continuity with late-stage potency, validation, transfer, and QC implementation strategies.
- Evaluate assay and cell line performance attributes, including sensitivity, specificity, robustness, stability, reproducibility, and fitness for intended use.
- Lead or contribute to technical transfers to internal laboratories, external partners, vendors, or quality control functions, providing the technical rationale and knowledge needed for transfer.
Data Analysis and Interpretation:
- Independently design and execute complex experimental plans, interpret data, identify technical risks, and recommend scientifically justified solutions.
- Author and review technical reports, protocols, method documents, cell line characterization packages, technology transfer documents, and CMC source documentation supporting regulatory submissions.
- Ensure that analytical cell line generation, assay development, documentation, and data packages are aligned with applicable quality and compliance expectations, good documentation practices, and data integrity principles.
Collaboration and Cross-Functional Support:
- Represent Analytical Development on cross-functional program teams and provide technical input on potency strategy, functional characterization, cell line suitability, and control strategy.
- Mentor associates through technical guidance, experimental design review, data interpretation, and development of scientific judgment.
Innovation and Continuous Improvement:
- Identify opportunities to improve workflows, increase assay robustness and reduce development timelines.
Knowledge and Skills:
Technical Skills:
- Proven proficiency in plate-based assays including ELISA, reporter gene assays, cytotoxicity/ADCC/CDC assays and other bioassay readout.
- Experience with technologies such as flow cytometry, qPCR or ddPCR is preferred.
- Familiarity with statistical tools and data analysis software (e.g., JMP, GraphPad Prism, SoftMax Pro and other bioassay data analysis software).
- Knowledge of USP, FDA and ICH guidelines governing bioassay development and validation.
Soft Skills:
- 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.
- Effective delivery of objectives within the preset timeline.
- Openness to using digital, automation, and AI-enabled tools to improve data analysis, documentation, knowledge management, and scientific workflows.
Education and Experience:- Ph.D. in Cell Biology, Molecular Biology, Biochemistry, Immunology, or a biology-related discipline with 0 - 3 years of relevant industry experience in biologics analytical development, bioassay development, cell line engineering, or functional characterization.
- Master's degree in biology-related scientific discipline and 3 years of work experience in biopharmaceutical industry or
- Bachelor's degree in biology-related scientific discipline and 6 years of work experience in biopharmaceutical industry.
- Experience developing analytical cell lines and cell-based potency or functional assays to support biologics development. Strong understanding of receptor biology, cellular signaling, reporter systems, mechanism of action, and their application to potency assay design.
Pay Range:$102,800 - $154,200
Disclosure Statement:The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.
At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.
Flex Designation:On-Site Designated
Flex Eligibility Status:In this
On-Site designated role, you will work
five days per week on-site with ad hoc flexibility.
Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.
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