Scientist I/II, Upstream Process Development

Location
Raleigh, North Carolina
Posted
Jul 25, 2021
Required Education
Bachelors Degree
Position Type
Full time
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 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. We have offices in San Francisco, Palo Alto, Boston, New York, and Raleigh with small satellites in other parts of the country.

To learn more, visit us at https://bridgebio.com

Who You Are:

The Scientist I/II– Upstream Process Development is a highly independent investigator within the Process Development group of the BridgeBio Gene Therapy CMC team. The position’s focus is the design and execution of process-specific experiments and the analysis/interpretation of data generated to develop efficient, highly productive, reproducible, and safe cGMP processes to manufacture AAV-based gene therapies. As such, this individual will collaborate directly with Downstream and Analytical Development and work in close partnership with both the Manufacturing and Research and Development groups. Additionally, Scientist I/II will serve as a technical expert on process-related topics in communications with internal stakeholders and external partners. As such, this individual will report to the Upstream Process Development lead to assist in the design, planning, and execution of cell culture development work. In addition to performing hands-on experiments in the lab, the role will work with Analytical Development counterparts to analyze and interpret data. This position also requires active participation in development-focused meetings and discussions.

Responsibilities:
  • Develop and optimize phase-appropriate cell culture/upstream processes for the manufacture of gene therapy drug candidates
  • Lead the design and execution of experiments in support of the above
  • Author protocols, process descriptions, and development reports
  • Work closely Analytical Development to ensure relevant analytics are available to make data-driven development decisions
  • Routinely collaborate with Downstream Development to engineer seamless, efficient, and robust processes
  • Generate material, as needed, to support Downstream and Analytical development work
  • Present results to colleagues, management, and external partners, when necessary
  • Help develop work plans to make sure timelines are met
  • Support technical transfer documentation of upstream processes during manufacturing campaigns
  • Accountably document, organize and provide 2nd scientist data verification of all experimental procedures, execution, and data generated
  • Assist in the maintenance of laboratory equipment


Education, Experience & Skills Requirements:
  • BS 7+/ MS 5+ years of direct experience in cell culture/upstream process development within the biopharmaceutical industry
  • Practical and theoretical knowledge of process development
  • Hands-on experience with single-use bioreactors, ideally across scales from 15 mL (i.e., ambr bioreactors) to 200 L.
  • Ability to both scale-up and scale-down processes to support development activities as needed
  • Strong Aseptic Technique
  • Familiarity with GLP and GDP
  • Practical knowledge of several of the following skills/techniques:
  • Routine subculture of suspension or adherent cells
  • Plasmid transfection and/or viral transduction
  • Setup and maintenance of single-use bioreactors
  • Depth filtration, tangential flow filtration, and sterile filtration
  • Buffer/solution preparation
  • Familiarity with Design of Experiments (DoE)/ statistical analysis software, such as JMP, a plus
  • The qualified candidate must be a team player that can effectively partner with diverse members across various functional groups


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; every minute counts, and let the 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
  • 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
  • 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


We will not accept unsolicited resumes from agencies. Please do not send agency resumes to our website or BridgeBio and affiliating employees.