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Senior Principal Scientist, Gene Editing Analytical Expert
2 months ago
**Job Summary**
We are seeking a highly experienced Senior Principal Scientist to lead our Gene Editing Analytical and Control Strategy Development team at BioCT Innovation Commons. As a key member of our Synthetic Product Development organization, you will be responsible for delivering phase-appropriate control strategies for our gene editing programs, encompassing mRNA, gRNA, and lipid nanoparticles (LNP) spanning preclinical development through first commercial launch.
Key Responsibilities- Develop, optimize, and validate analytical methods for mRNA, gRNA, ionizable lipids, and LNP products at Contract Research Organizations (CROs)/Contract Development and Manufacturing Organizations (CDMOs).
- Propose scientifically sound, phase-appropriate specifications and deliver comprehensive strategies for impurity characterization and qualification.
- Provide analytical control strategy expertise to enable Module 3 authoring of regulatory submission documents that convey phase-appropriate scientific understanding, spanning IND/IMPD through commercial licensure.
- Lead sophisticated technical development projects and remotely manage development timelines at CROs/CDMOs.
- Remain abreast of the latest developments pertaining to gene editing control strategy and proactively evaluate emerging technologies and regulatory trends.
- Collaborate with cross-functional teams to design, develop, optimize, and scale-up mRNA, gRNA, and LNP manufacturing processes.
- Ph.D. in analytical chemistry, biochemistry, bioanalytical chemistry, or a related field with a minimum of 12 years of industry experience in analytical and control strategy development for gene editing programs.
- Solid understanding of current regulatory guidelines and cGMP requirements pertaining to gene editing.
- Strong experience in preparing regulatory submissions for gene editing programs and responding to inquiries from health authorities.
- Proven record of leading technical development projects and remotely managing development timelines at CROs/CDMOs.
- Technical expertise and intellectual curiosity to remain abreast of the latest developments pertaining to gene editing control strategy.
- Strong understanding of the design, development, optimization, and scale-up of mRNA, gRNA, and LNP manufacturing processes.
- Up to 10% travel, with the ability to work independently from remote locations.
- Prior firsthand experience in delivering phase-appropriate control strategies for siRNA and/or ASO therapeutics spanning clinical through commercial launch, including Module 3 authoring for NDA/MAA submissions and responses to health authority queries.
- Experience with online process analytical techniques to accelerate development and enable enhanced control strategies for multi-step continuous manufacturing processes.
