Associate Scientist, Manufacturing Science and Technology

Full-TimeBridgeBio Gene TherapyRaleigh, NCManufacturing

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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 Associate Scientist – Manufacturing Science and Technology (MSAT) is a member of the interdisciplinary CMC group at BridgeBio Gene Therapy (BBGT). The MSAT team takes ownership of BBGT processes through a hands-on partnership with the Process Development team, actively leading technology transfers to our cGMP manufacturing facility and providing scientific and technical support during the clinical manufacture of our gene therapy products. The primary focus of this position is to assist in the transfer and implementation of product and process knowledge from development to manufacturing. This individual will contribute to technical aspects of clinical manufacturing through drafting/editing tech transfer plans and batch records as well as investigating deviations and CAPAs; additionally, the incumbent will collaborate closely with the Upstream and Downstream Development teams throughout process development, including hands-on preparation, design, and execution of pilot-scale runs. The Associate Scientist will also work in close partnership with both internal and external quality associates. This role requires regular site visits to our manufacturing partner(s).
Responsibilities:
  • Engage in technology transfers and support clinical manufacturing activities
  • Work cross-functionally with process development and manufacturing to support technology transfer
  • Work alongside Upstream and Downstream Development teams to foster a deep understanding of manufacturing processes
  • Execute scale-down/scale-up validation studies, process range studies, and process robustness experiments
  • Partner with Upstream and Downstream Development teams to plan, execute and analyze pilot-scale runs 
  • On-the-floor support during Engineering and GMP Runs
  • Author/primary reviewer of process descriptions, batch and formulation records, standard manufacturing/operation procedures, and change controls
  • Work closely with quality groups to support deviations and CAPAs
  • The role requires approximately 30% travel
Education, Experience & Skills Requirements:
  • Degree in Biology; Chemistry; Biochemistry; Chemical or Bioengineering; or related disciplines
  • BS + 2, MS + 0 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
  • Harvest clarification
  • 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 working in cGMP environment, especially drafting/reviewing documentation and/or operations
  • Strong technical writer
  • Working knowledge of process technologies, including upstream and downstream single-use equipment, assemblies, consumables, and raw materials
  • 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
We will not accept unsolicited resumes from agencies. Please do not send agency resumes to our website or BridgeBio and affiliating employees.
careers

Associate Scientist, Manufacturing Science and Technology

Full-TimeBridgeBio Gene TherapyRaleigh, NCManufacturing

Apply Now