Scientist, Bioassay-Analytical Development, CMC

Location
Raleigh, NC, United States
Posted
Sep 27, 2020
Ref
402031469
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time
Who You Are

The Scientist of Bioassay-Analytical Development will be a member of the CMC Analytical team and is responsible for developing new assays and testing activities relating to the rAAV-based gene therapy candidates to enable their cGMP production and release. This individual will work in partnership with Pre-Clinical Development, Upstream/Downstream Process/Formulation Development functions, and external CROs to deliver products for clinical testing.

Responsibilities
  • Develop and qualify new assay methods including in vitro cell-based assays, immune assays, and molecular assays to support product release testing or in support of IND enabling non-clinical studies
  • Plan strategies for and participate in the development, qualification, and transfer of quantitative and semi-quantitative bioanalytical/bioassay methods to support preclinical, clinical programs and product release tests at CROs
  • Support 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 the highest quality and regulatory standards
  • Document experimental data, results, and conclusions in an electronic laboratory notebook

Education, Experience & Skills Requirements
  • Ph.D./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 AAV- gene therapies will be considered a plus.
  • Proven hands-on experience and working knowledge with some or most of the following assays: ELISA-based assays, qPCR/ddPCR, Spectrophotometry, Gel Electrophoresis. Two years of experience in this area is highly preferred.
  • Advanced proficiency in basic biological laboratory techniques, including ELISA, immunoblot, PCR, mammalian cell culture, and transfection
  • 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, protocols and technical reports for internal documents and regulatory filings
  • 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
  • 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 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