BridgeBio Pharma, Inc.
Raleigh, North Carolina
BridgeBio finds, develops, and delivers breakthrough medicines for genetic diseases. The company bridges remarkable advancements in genetic science with the entrepreneurial engine required to rapidly create lifesaving medicines for patients with unmet needs. Founded in 2015 by a team of industry veterans, the company has built a portfolio of 20 transformative drugs ranging from pre-clinical to late stage development in multiple therapeutic areas including genetic dermatology, oncology, cardiology, neurology, endocrinology, renal disease, and ophthalmology. The company’s focus on scientific excellence and rapid execution aims to translate today’s discoveries into tomorrow’s medicines.
The Associate Scientist of Biophysical Chemistry-Analytical Development will be a member of the CMC Analytical team and is responsible for executing assay development and testing activities relating to the biophysical, structural and molecular attributes of rAAV-based gene therapy candidates to enable their cGMP production and release. This individual will work in partnership with Non-Clinical Development, Upstream/Downstream Process/Formulation Development functions and external CROs to deliver products for clinical testing.
At this time we are unable to offer relocation or sponsorship for this position.
- Develop, optimize, qualify and transfer phase-appropriate analytical assays such as LC, CE, ddPCR/qPCR, ELISA and AUC to support non-clinical, CMC and clinical development of gene therapy drug candidates
- Support analytical method transfer to and from external CRO laboratories.
- Contribute to the execution of experiments for qualitative and quantitative characterization of recombinant AAV-based gene therapy candidates
- Supports upstream and downstream process optimization during CMC development by generating timely analytical test results regarding the quality attributes of the in-process materials
- Perform the testing of routine samples and maintain rapid turnaround times while prioritizing work according to the company and program needs to make sure timelines are met
- Author technical reports, work instructions, standard operating procedures and qualification/validation protocols.
- 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 highest quality and regulatory standards
- Document experimental data, results, and conclusions in an electronic laboratory notebook
- BS or MS in Biochemistry, Molecular Biology, Analytical Chemistry, Virology or a related field.
- At least 2+ years of industrial experience in biotechnology and/or the biopharmaceutical field.
- Prior experience with vector-based gene therapies will be considered a plus.
- Knowledge of and Experience with Design of Experiment (DOE) methodology for assay development is preferred
- Familiarization with ICH and FDA guidelines is expected. Experience in qualifying and transferring analytical test methods is desired.
- Ability to troubleshoot instrumentation and analytical test methods
- Must have strong 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 his/her 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.
- Level will be commensurate with experience
- Proven hands-on experience and working knowledge with some or most of the following assays: ELISA-based assays, qPCR/ddPCR, Analytical Ultracentrifugation, Spectrophotometry, Gel Electrophoresis, SDS-PAGE, H/UPLC, LC-MS
What we offer:
- Patient Days, where we are fortunate enough to learn more about the lives we are looking to impact and a real exchange of ideas as to how we can improve our efforts.
- A culture inspired by our values: put patients first; think independently, be radically transparent; act nimbly; and let science speak.
- Learning and development training to help employees be the best version of themselves.
- Collaborative business environment.
- Excellent compensation package (Base, Performance Bonus, Stock, RSU programs).
- Excellent benefits package.
- Flexible PTO.
- With office locations in San Francisco, Boston, New York and Raleigh, there are ample cross-collaboration opportunities with other BridgeBio Pharma programs.
- 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.
- A platform for meaningful scientific contributions to shine.
- Commitment to Diversity & Inclusion – with initiatives like Women at Bridge, we are committed to fostering an inclusive environment where every person feels respected for who they are, empowered to contribute, inspired to lead and supported in their efforts to do so.