Senior Scientist, Analytical Development, Bioassay Development, Biologics
Vertex Pharmaceuticals
5 hours ago
On-site
Boston, MA
Operations
Key Responsibilities
- Design, develop, and optimize bioassays to support characterization, potency, and stability testing of biologics.
- Support tech transfer to external QC; perform troubleshooting and analytical investigation.
- Implement cutting-edge technologies and methodologies to enhance assay robustness and performance.
- Manage CROs for cell line development for use in bioassays; provide technical guidance and ensure alignment with project goals and timelines.
- Troubleshoot and resolve technical challenges related to cell line development and maintenance.
- Lead qualification and validation of bioassays in compliance with regulatory guidelines (e.g., USP, FDA, ICH).
- Author and review technical reports, SOPs, and regulatory submission documents.
- Analyze experimental data using statistical tools/software; interpret results and provide scientific insights to guide product development.
- Collaborate with cross-functional teams (Analytical Development, Process Development, Regulatory Affairs); provide technical expertise to junior scientists.
- Stay current with bioassay technology advancements and industry trends; implement innovative approaches to improve assay performance and efficiency.
Qualifications
- Ph.D. in immunology, cell biology, or a biology-related discipline with 3–5 years biopharmaceutical industry experience; or Master’s with 5 years; or Bachelor’s with 8 years.
- Hands-on experience developing and qualifying/validating bioassays for biologics in regulatory compliance.
- Strong background in cell line development for assay purposes.
- Proven proficiency in ELISA, reporter gene assays, cytotoxicity/ADCC/CDC assays, and other bioassay readouts.
- Familiarity with statistical tools/software (e.g., JMP, GraphPad Prism, SoftMax Pro).
- Familiar with USP, FDA, and ICH guidelines governing bioassay development and validation.
- Ability to manage competing priorities, meet timelines, solve problems, and communicate complex data; collaborative and leadership/mentoring skills.
Additional
- Up to 10% travel required.
- Pay range: $122,400–$183,600 (eligible for annual bonus and annual equity awards).
Flex/Work Location
- Boston, MA. On-site role: five days per week on-site with ad hoc flexibility.
Application assistance: ApplicationAssistance@vrtx.com
- Design, develop, and optimize bioassays to support characterization, potency, and stability testing of biologics.
- Support tech transfer to external QC; perform troubleshooting and analytical investigation.
- Implement cutting-edge technologies and methodologies to enhance assay robustness and performance.
- Manage CROs for cell line development for use in bioassays; provide technical guidance and ensure alignment with project goals and timelines.
- Troubleshoot and resolve technical challenges related to cell line development and maintenance.
- Lead qualification and validation of bioassays in compliance with regulatory guidelines (e.g., USP, FDA, ICH).
- Author and review technical reports, SOPs, and regulatory submission documents.
- Analyze experimental data using statistical tools/software; interpret results and provide scientific insights to guide product development.
- Collaborate with cross-functional teams (Analytical Development, Process Development, Regulatory Affairs); provide technical expertise to junior scientists.
- Stay current with bioassay technology advancements and industry trends; implement innovative approaches to improve assay performance and efficiency.
Qualifications
- Ph.D. in immunology, cell biology, or a biology-related discipline with 3–5 years biopharmaceutical industry experience; or Master’s with 5 years; or Bachelor’s with 8 years.
- Hands-on experience developing and qualifying/validating bioassays for biologics in regulatory compliance.
- Strong background in cell line development for assay purposes.
- Proven proficiency in ELISA, reporter gene assays, cytotoxicity/ADCC/CDC assays, and other bioassay readouts.
- Familiarity with statistical tools/software (e.g., JMP, GraphPad Prism, SoftMax Pro).
- Familiar with USP, FDA, and ICH guidelines governing bioassay development and validation.
- Ability to manage competing priorities, meet timelines, solve problems, and communicate complex data; collaborative and leadership/mentoring skills.
Additional
- Up to 10% travel required.
- Pay range: $122,400–$183,600 (eligible for annual bonus and annual equity awards).
Flex/Work Location
- Boston, MA. On-site role: five days per week on-site with ad hoc flexibility.
Application assistance: ApplicationAssistance@vrtx.com