Scientist I/II - Technology Transfer Lead

Raleigh, NC
Oct 14, 2020
Required Education
Bachelors Degree
Position Type
Full time

Who You Are

The Scientist - Technology Transfer Lead is a highly independent member of the Technical Development team within the integrated, interdisciplinary CMC group at BridgeBio Gene Therapy. This position's primary focus is to lead the transfer of product and process knowledge from development to manufacturing to ensure cGMP processes are efficient, robust, and safe. This individual will collaborate closely with the Upstream and Downstream Development teams throughout process development and will lead technical aspects of current and future work at our GMP manufacturing partner, including but not limited to, drafting/editing tech transfer plans, batch records, deviations, and CAPAs. Additionally, the Scientist will work in close partnership with both internal and external quality associates. The role also requires regular site visits to our manufacturing partner(s).



  • Provide subject matter expertise to lead technology transfers and support clinical manufacturing activities
  • Work cross-functionally with process development, program, manufacturing, and clinical groups to design program-specific technology transfer plans
  • Ensure that manufacturing milestones and timelines are met
  • Procurement and supply chain management at manufacturing partner
  • On-the-floor support during Engineering and GMP Runs
  • Lead technical troubleshooting during runs as needed
  • Author/primary reviewer of process descriptions, batch and formulation records, and change controls
  • Work closely with quality groups to support deviations and CAPAs
  • Routinely collaborate with Upstream and Downstream Development teams to foster a deep understanding of manufacturing processes
  • Support/design/execute scale-down/scale-up validation studies, process range studies, and process robustness experiments
  • Present relevant data and manufacturing updates to colleagues, management, and external partners
  • Approximately 30% of travel

Education, Experience & Skills Requirements



  • Degree in Biology; Chemistry; Biochemistry; Mechanical, Chemical or Bioengineering; or related disciplines
  • BS + 5, MS + 2 years of direct experience in upstream/downstream processing within the biopharmaceutical industry
  • Hands-on experience with cell culture and purification processes, including:
  • Cell culture bioreactors
  • Depth filtration
  • Ultrafiltration/diafiltration
  • Tangential flow filtration
  • Ion exchange/affinity/size exclusion chromatography
  • Practical and theoretical knowledge of process development; direct experience with viral vector drug substance a plus
  • Ability to scale-up and scale-down processes to support both development and manufacturing activities as needed
  • Experience transferring processes from PD to cGMP manufacturing
  • Experience with equipment in a cGMP environment
  • Strong technical writer
  • The qualified candidate must be a team player that can effectively partner with diverse members across various functional groups
  • Level commensurate with experience

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