The Senior Scientist/Associate Director will design, plan, and coordinate CMC analytical activities for LNP programs. The primary focus of this role will focus on CMC related analytical activities, such as method development and qualification, non-GMP stability, reference standard establishment and qualification for early-stage clinical programs. In addition to the Analytical CMC responsibilities, this individual will also be a technical expert in a variety of RNA and LNP analysis and responsible for designing and overseeing various laboratory responsibilities. The ideal candidate will have experience in design and development of analytical methods for gRNA, mRNA, lipids, and LNP, experience working collaboratively with cross-functional CMC teams and external testing labs, familiar with GMP/GLP regulatory requirement, and have a working knowledge of analytical ICH/USP guidelines.
- Contribute to the Analytical CMC Strategy for Beam’s LNP programs as analytical lead.
- Work on cross-functional CMC team progressing LNP candidates from pre-clinical through commercial launch.
- Oversee the development, optimization, and qualification of analytical methods used for lot release, stability, and characterization of lipids, and LNP as analytical representative.
- Coordinate internal and external analytical testing activities and may also serve as technical SME for one of more assays.
- Work with cross-functional partners in research & development and quality control on various aspects of method development, tech transfer, comparability, product characterization, and manufacturing investigations.
- Manage external contract labs as analytical point of contact.
- Establish Non-GMP Stability for LNP programs.
- Creation of justification of specifications for LNP programs.
- Contribute/author relevant sections of IND and BLAs as well as respond to regulatory agency questions.
- Interface with CMC, Quality, Regulatory, Manufacturing, Process Development, and Beam partners.
- Mentor and train junior scientists, with the potential to manage a small team of analytical scientists.
- Living Beam Therapeutics core values of being part of a community of fearless innovators, being rigorous and honest in our research, listening with open minds, and committed to each other.
- Degree in a relevant discipline (biochemistry, biotechnology, biological sciences, bioengineering, or related fields).
- Minimum 12-15 years (BS, MS) or 4-7 years (PhD) industry experience (including biotech, biopharma, CRO, CDMO) including hands on experience in cell and gene therapy.
- Deep understanding of analytical method development and qualification for LNP, lipids, and RNA is desirable.
- Direct analytical CMC experience is desirable.
- People management experience will be a plus.
- Experience managing both internal and external partners.
- Extensive experience with at least one or several of the analytical techniques is required: HPLC (IPRP, SEC, IEX), capillary gel electrophoresis, fluorescence-based RNA quantitation. Experience with PCR, DNA and RNA extraction, ELISA, UV spectrophotometry, DLS, MALS, mass spectrometry, and compendial testing will be a plus.
- Knowledge and experience in CMC and regulatory strategy, cGMP, ICH guidelines, USP and EP compendial methods applied to cell and gene therapy.
- Extensive scientific writing experience, experience authoring IND and related documentation.
- Strong leadership, self-starter and excellent oral and written communication skills.