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Job: Senior Associate Scientist, Analytical Development and CMC, BridgeBio Gene Therapy Inc., Raleigh, NC, NC

General Information


Job title:
Senior Associate Scientist, Analytical Development and CMC
Job location:
Raleigh, NC, NC  27607 United States
Requisition code:
Date posted:
10/25/2021
Compensation:
• Excellent compensation & benefits package (Base, Performance Bonus, Stock, RSU programs)
• Flexible PTO
• A fast-paced, data-driven, work environment with world-class R&D minds and capabilities
• Work with the most productive groups of R&D operators in the industry
• Partnerships with leading institutions
• Commitment to Diversity & Inclusion
Job category:
Manufacturing and Production
Employment type:
Full time

Job Description


About BridgeBio

BridgeBio is a biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. We bridge the gap between remarkable advancements in genetic science in academic institutions and the delivery of meaningful medicines to patients. Founded in 2015, the company has built a portfolio of 30+ drug development programs ranging from preclinical to late-stage development in multiple therapeutic areas including genetic dermatology, precision oncology, cardiology, endocrinology, neurology, pulmonology, and renal disease, with two approved drugs.

Our focus on scientific excellence and rapid execution aim to translate today’s discoveries into tomorrow’s medicines. We have U.S. offices in San Francisco, Palo Alto, Boston, New York, and Raleigh, with small satellites in other parts of the country. We also have international offices in Montreal, Canada, and Zug, Switzerland, and are expanding across Europe.

To learn more about our story and company culture, visit us at https://bridgebio.com

Who You Are:
The Senior Associate Scientist of Analytical Development will be a member of the CMC Analytical Development team and is responsible for assay development, optimization, and testing activities relating to the biophysical, structural, and molecular attributes of recombinant AAV-based gene therapy candidates. This individual will partner with the Non-Clinical Development, Upstream/Downstream Process/Formulation Development functions, and external CROs to deliver products for clinical testing.

Responsibilities:
• Develop, optimize, and troubleshoot analytical assays such as liquid chromatography (H/UPLC, LC-MS), electrophoresis (CE, cIEF), DLS, • • • AUC, ELISA, and ddPCR for qualitative and quantitative characterization of recombinant AAV (rAAV) based gene therapy candidates to support non-clinical, CMC and clinical development of gene therapy drug candidates
• Manage external CRO characterization and analytical projects
• Supports upstream and downstream process optimization during CMC development by generating timely characterization results
• Author technical reports, work instructions, and standard operating procedures
• Provide data and technical documents in support of regulatory filings such as IND and BLA submissions
• Troubleshoot instrumentation and analytical testing methods when necessary; support laboratory operations including instrument maintenance and supplies management
• Prepare and deliver progress presentations on protocols, experiments, and data to scientific colleagues, management, and external partners
• Ensure all experimental procedures and documentation are compliant with the highest quality and regulatory standards
• Document experimental data, results, and conclusions in an electronic laboratory notebook

Job Requirements


• BS or MS in Biochemistry, Molecular Biology, Analytical Chemistry, Virology or a related field
• At least 5+ years of industrial experience in biotechnology and/or the biopharmaceutical field
• The success at this role will depend on the candidate’s ability to independently analyze and interpret scientific data, form conclusions, and propose solutions
Prior experience with vector-based gene therapies will be considered a plus
• Proven hands-on experience and working knowledge with some or most of the following assays: AUC, Spectrophotometry, Electrophoresis (CE and cIEF), ELISA, SDS-PAGE, ddPCR, H/UPLC, LC-MS, and Light Scattering
• Working knowledge of the structure and function of rAAV capsid particles and/or biologics
• Ability to troubleshoot biophysical instrumentation and analytical test methods
• Must have solid scientific documentation skills to support the writing of electronic notebook entries, SOPs, protocols, and technical reports for internal documents and regulatory filings
• The candidate must be a self-motivated and detail-oriented person who can effectively communicate results and conclusions to their colleagues and management
• Ability to multitask among multiple projects in a fast-paced environment
• The qualified candidate must be a team player that can effectively partner with diverse team members from various functions such as preclinical, process development, and external CROs
• Excellent written and verbal communication skills
(Job number: 4052090)
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