Senior Associate Scientist, Analytical Development and CMC

Full-TimeBridgeBio Gene TherapyRaleigh, NCManufacturing

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About BridgeBio Gene Therapy & BridgeBio Pharma

BridgeBio Gene Therapy, a subsidiary of BridgeBio Pharma, is focused on discovering and developing drugs for patients with grievous genetic diseases. We do this by:

Finding the right starting points to target diseases at their source.

Using a combination of a systematic assessment of the genetic disease landscape and informed diligence on the latest research, we find indications with clear mechanisms of pathogenesis that are ripe for translation into disease-modifying drugs.

Building products with world-class R&D personnel.

We employ industry-leading scientists that work closely with leading academics to prosecute a wide variety of drug programs at the highest level of scientific rigor. Our team combines biopharmaceutical veterans with up-and-coming leaders to drive entrepreneurial thinking grounded by experience.

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 aims 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

  • No matter your role at BridgeBio, successful team members are:
  • Patient Champions, who put patients first and uphold strict ethical standards
  • Entrepreneurial Operators, who drive towards practical solutions and have an ownership mindset
  • Truth Seekers, who are detailed, rational, and humble problem solvers
  • Individuals Who Inspire Excellence in themselves and those around them
  • High-quality executors, who execute against goals and milestones with quality, precision, and speed
Education, Experience & Skills 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
What We Offer:
  • Patient Days, where we are fortunate to hear directly from individuals living with the conditions we are seeking to impact throughout the year and learn how we can improve our efforts
  • A culture inspired by our values: put patients first, think independently, be radically transparent, every minute counts, and let the science speak
  • An unyielding commitment to always putting patients first. Learn more about how we do this here
  • A de-centralized model that enables our program teams to focus on advancing science and helping patients. Our affiliate structure is designed to eliminate bureaucracy and put decision-making power in the hands of those closest to the science
  • A place where you own the vision – both for your program and your own career path
  • A collaborative, fast-paced, data-driven environment where we inspire ourselves and each other to always perform at the top of our game
  • Access to learning and development resources to help you get in the best professional shape of your life
  • Robust and market competitive compensation & benefits package (Base, Performance Bonus, Equity, health, welfare & retirement programs)
  • Flexible PTO
  • Rapid career advancement for strong performers
  • Potential ability to work on multiple BridgeBio Pharma programs across multiple therapeutic areas over time
  • Partnerships with leading institutions
  • Commitment to Diversity, Equity & Inclusion – with initiatives like Women at Bridge, we are committed to fostering an inclusive environment where every person feels seen, valued, and heard
We will not accept unsolicited resumes from agencies. Please do not send agency resumes to our website or BridgeBio and affiliating employees.
careers

Senior Associate Scientist, Analytical Development and CMC

Full-TimeBridgeBio Gene TherapyRaleigh, NCManufacturing

Apply Now