Senior Scientist, CMC, Quality Control

City Therapeutics•Cambridge, MA

37d•$136,000 - $154,000•Onsite

About The Position

City Therapeutics is seeking a passionate Senior Scientist, CMC Quality Control to join our growing team. The current focus will be on release and stability management of oligonucleotide drug substances, drug products, and process intermediates (e.g., siRNA and conjugates). You will also lead method transfer and qualification to support internal labs and external partners. This role will report to the Senior Director, CMC AD/QC and contribute directly to City’s next-generation siRNA programs.

Requirements

Ph.D. in Analytical Chemistry or related field with 3+ years relevant industry experience; M.S. with 7+ years; or B.S. with 10+ years.
CDMO experience is highly valued.
Strong AX-HPLC and HPLC–MS technical background with hands-on oligonucleotide analysis experience.
Proven understanding of analytical instrumentation theory and practice across DS/DP development and manufacturing processes.
Demonstrated skills in handling, analyzing, and characterizing oligonucleotides and related organic molecules.
Familiarity with cGxP expectations, analytical data systems, and data integrity principles.
Meticulous documentation, strong problem-solving, and the ability to operate with minimal supervision.
Excellent communication, organization, and teamwork skills; comfortable in a fast-paced, multi-project environment with shifting priorities.

Nice To Haves

Knowledge of CMC regulatory requirements (e.g., IND/IMPD) is a plus.
Understanding of basic theories and principles of synthetic organic chemistry is a plus

Responsibilities

Lead method verification/qualification, validation (as needed), and method transfer for existing and new programs.
Manage stability protocols and reports from partners
Conduct exploratory stability studies for raw materials, intermediates, DS, and DP; interpret trends and recommend actions.
Work both independently and with cross-functional teams to plan, prioritize, and meet project timelines.
Write CMC source documents such as, but not limited to, analytical methods, qualification/validation protocols and reports
Operate, calibrate, maintain, and troubleshoot analytical instrumentation; ensure adherence to data integrity and safety practices.