Senior/Principal Scientist, CMC Process Development and Manufacturing

City Therapeutics•Cambridge, MA

10h•$136,000 - $185,000•Onsite

About The Position

City Therapeutics is looking for a passionate Senior/Principal Scientist CMC Process Development and Manufacturing who will be responsible for leading drug substance process development projects for our programs at different stages, with a focus on process development and process characterization for oligonucleotides with novel chemical modifications. The role involves overseeing development projects, supporting non-GMP and GMP drug substance manufacturing, and collaborating with various cross-functional teams both internal and external. The ideal candidate must have strong problem-solving skills, extensive knowledge of oligonucleotide chemistry, and proven experience in oligonucleotide process development. This position is fully onsite and will be primarily located at our Cambridge, MA location.

Requirements

B.S., M.S., or Ph.D. degree in organic, analytical chemistry, chemical engineering, biochemistry or related degrees with the following pharmaceutical industry experience
10+ years with a B.S degree/M.S. Degree; 5+ years with a Ph.D. degree
Strong experience and knowledge in oligonucleotide synthesis, downstream processing, risk assessment and process characterizations.
Hands-on experience in automated solid-phase synthesizers and other instrumentation involved in oligonucleotide production, demonstrated strong operational execution and problem-solving skills.
Experience in building and managing relationships with 3rd parties and leading virtual CMC teams to deliver process control strategies for drug substances and drug products.
Experience in working with oligonucleotides methodologies and strategies in a highly matrixed environment.
Experience in early and or late-stage drug development and regulatory filings
Ability to work in a fast-paced, multi-disciplinary and dynamic environment with potential for changing priorities, with flexibility to support multiple development programs simultaneously.
Experience across multiple therapeutic modalities (small molecules, oligonucleotides, peptides and large molecules) is a plus
Excellent communication and organization skills and a great team player

Nice To Haves

Experience in CDMOs with hands-on oligonucleotide processes, both upstream and downstream activities.
Experience in authoring CMC sections for regulatory submissions.
Strong project management skills with the ability to manage multiple priorities and deadlines.
Innovation-driven with a focus on continuous improvement and problem-solving.

Responsibilities

Lead process development projects including oligonucleotide synthesis activities, process development, optimization and scale-up, and process characterizations.
Collaborate with Drug Substance, Drug Product and Quality Assurance to ensure strong cross functional collaborations and serve the PD/Mfg functional line to ensure that the team meets technical project timelines and milestones.
Communicate relevant information and results to CMC team as well as other key stakeholders throughout the City Therapeutics organization.
Technical protocols and reports authoring and reviewing.
Oversee efficient and effective development, utilization, and transfer of optimized process parameters for drug substances and/or drug products that meet or exceed the current regulatory expectations and ensure the high and consistent quality and performance of drug substances and drug products.
Author and review DS/DP documentation including, but not limited to, process development reports, master and executed batch records, release and stability testing reports.
Build and maintain strong relationships with internal and external partners Contract Manufacturing Organizations (CMOs), analytical labs, and CMC advisors to ensure successful process and analytical strategies and executions
Author and review high-quality CMC packages for submissions that meet or exceed the expectations of external regulators and lead to first-cycle approvals.