Qureos Mentor

City Therapeutics

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 We are seeking a passionate Senior Scientist, CMC Analytical Development to join our growing team. You will lead method development, qualification, and transfer to support internal labs and external partners. The role is hands-on and highly cross-functional, partnering with CROs/CMOs to define impurity profiles and deliver comprehensive characterization of oligonucleotide drug substances, drug products, and process intermediates (e.g., siRNA and conjugates). You will report to the Director, CMC Analytical Development and contribute directly to City&rsquo;s next-generation siRNA programs.
 
 
 
 Please note this is a full-time onsite opportunity
 
 
 
 
 Responsibilities
 
 
 
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 Independently design and execute analytical methods for oligonucleotides and conjugates; drive continuous method improvement.
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 Apply advanced scientific principles to solve complex analytical problems; propose innovative, phase-appropriate solutions.
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 Lead method development, verification/qualification, validation (as needed), and transfer for existing and new programs.
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 Develop and implement analytical technology such as HPLC-MS methods for impurity characterizations of oligonucleotides
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 Conduct exploratory stability studies for raw materials, intermediates, DS, and DP; interpret trends and recommend actions.
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 Generate high-quality data; analyze, interpret, and communicate results; propose data-driven next steps.
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 Work both independently and with cross-functional teams to plan, prioritize, and meet project timelines
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 Write CMC source documents such as, but not limited to, analytical methods, development reports, qualification/validation protocols and reports
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 Operate, calibrate, maintain, and troubleshoot analytical instrumentation; ensure adherence to data integrity and safety practices.
 
 
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 Qualifications
 
 
 
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 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.
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 Strong AX-HPLC and HPLC&ndash;MS technical background with hands-on oligonucleotide characterization experience.
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 Proven understanding of analytical instrumentation theory and practice across DS/DP development and manufacturing processes.
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 Demonstrated skills in handling, analyzing, and characterizing oligonucleotides and related organic molecules.
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 Familiarity with cGxP expectations, analytical data systems, and data integrity principles.
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 Knowledge of CMC regulatory requirements (e.g., IND/IMPD) is a plus.
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 Understanding of basic theories and principles of synthetic organic chemistry is a plus
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 Meticulous documentation, strong problem-solving, and the ability to operate with minimal supervision.
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 Excellent communication, organization, and teamwork skills; comfortable in a fast-paced, multi-project environment with shifting priorities.
 
 
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 City Therapeutics is accepting resumes/CVs from direct applicants only. Recruitment Agency inquiries and 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 or liability for 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.
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Sr. Scientist, CMC Analytical Development

Join City Therapeutics and explore 1   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

City Therapeutics

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Sr. Scientist, CMC Analytical Development