Senior Scientist, CMC Quality Control in Cambridge

• Senior Scientist, CMC Quality Control
• Job Summary

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., si RNA 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 si RNA programs.

Please note this is a full-time, onsite opportunity

Key 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.

Qualifications

• 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 c Gx P expectations, analytical data systems, and data integrity principles.
• 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
• 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.

Compensation

The base salary range provided reflects our current estimate of what we anticipate paying for this position.

Your actual base salary will be based on several factors, including relevant skills, experience, internal equity, relevant education or training and market dynamics.

In addition, this role is eligible for an annual cash bonus and equity compensation.

City Therapeutics offers a comprehensive and competitive benefits package including medical, dental, vision, life insurance, health and dependent care FSA accounts, HSA/HRA accounts with company contributions, in addition to a 401(k) with competitive company match.

Per Year Salary Range: $136,000 to $154,000.

City Therapeutics is accepting resumes/CVs from direct applicants only. Recruitment agency submissions will not be accepted at this time.

City Therapeutics is an Equal Opportunity and Affirmative Action employer committed to a culturally diverse workforce.

All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership, or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing); or any other characteristic protected by law.