Are you a highly experienced and driven scientist with a passion for developing innovative therapies? If so, we are looking for you to join our team in Boston, United States, as a Principal Scientist for CMC Analytical Development. In this role, you will play a crucial part in advancing the company's targeted nucleotide delivery platform from preclinical stages through early-phase clinical trials.
As our Principal Scientist of CMC Analytical Development, you will have the following responsibilities:
- Develop a phase-appropriate analytical control strategy for proteins, mRNA, DNA, and nanoparticles. You will be responsible for overseeing the testing, data analysis, and interpretation of results from these analytical methods.
- Act as a Subject Matter Expert (SME) on physicochemical methods and oversee all related CMC activities. You will provide scientific and technical guidance to other team members, ensuring that all activities are conducted in a timely and efficient manner.
- Design experiments that advance the understanding of structure/function relationships of development candidates in immuno-oncology and infectious disease portfolios. You will collaborate with other members of the team to design and execute experiments that help to elucidate the mechanism of action of our therapeutic candidates.
- Author and contribute to sections for IND and IMPD regulatory submissions
To be considered for this position, applicants must meet the following requirements:
- Ph.D. with a strong scientific background and a deep understanding of the principles of analytical chemistry and physicochemical characterization.
- Have a minimum of 3+ years of industry experience at a senior level and a minimum of 6+ years of industry experience at a principal level.
- Proven track record of leading analytical development activities for biologics or nucleotide-based therapeutics (RNA, DNA, nanoparticles, oligonucleotides).
- Experience working with Contract Manufacturing Organizations (CDMOs).
- Track record of developing physicochemical methods