- Independently design and develop analytical methods for new chemicals, DNA oligonucleotides, new types of RNA APIs, and LNP formulations under development.
- Lead the research efforts on nucleic acid purification using a wide range of analytical tools.
- Author and compile analytical method development and technical reports, SOPs, IQ/OQ documents, and CMC sections for regulatory submissions.
- Maintain competency and stay updated with training for relevant processes and equipment.
- Ensure that all work is executed with accuracy, precision, proper documentation, and adherence to GMP requirements.
- Organize multiple project responsibilities to ensure tasks are appropriately prioritized and completed within specified timelines.
- Design, coordinate, and execute development activities, including API, formulation, data interpretation, equipment selection, generation of QC reports, and other appropriate documentation, while actively engaging in problem-solving exercises.
- Other duties as assigned
- Ph.D. degree in pharmaceutical science, analytical chemistry, biochemistry, chemical engineering, or an MS in a related field with a minimum of 3 years of experience in the pharmaceutical company, biotech, or related industries.
- Strong knowledge of analytical chemistry and pharmaceutical science
- Over 4 years of relevant experience in analytical method development, with hands-on expertise in HPLC and LC-MS.
- Extensive experience with analytical characterization of API and formulations in the pharmaceutical industry is preferred.
- Excellent communication and problem-solving skills, enabling effective cross-functional interactions.
- Proven ability to work collaboratively with team members, fostering a supportive and cooperative environment.
- Possesses a sense of humility and maintains an eagerness to continue learning.
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Research Scientist, Analytical Chemistry - Redmond, United States - GenScript
Description
About GenScriptGenScript Biotech Corporation (Stock Code: 1548.HK) is a global biotechnology group. Founded in 2002, GenScript has an established global presence across North America, Europe, the Greater China, and Asia Pacific. GenScript's businesses encompass four major categories based on its leading gene synthesis technology, including operation as a Life Science CRO, enzyme and synthetic biology products, biologics development and manufacturing, and cell therapy.
GenScript is committed to striving towards its vision of being the most reliable biotech company in the world to make humans and nature healthier through biotechnology
About GenScript ProBio
GenScript ProBio is the subsidiary of GenScript Biotech Corporation, proactively providing end-to-end CDMO service from drug discovery to commercialization with proactive strategies, professional solutions and efficient processes in cell and gene therapy (CGT), vaccine, biologics discovery and antibody protein drug to accelerate drug development for customers. GenScript ProBio's total cell and gene therapy solution covers CMC of plasmid and virus for IND filing as well as clinical manufacturing and commercial manufacturing. In terms of plasmid service, GenScript ProBio supports the most clinical approvals for CGT drugs including mRNA vaccines, CAR-T in China. It is also the first GMP manufacturing platform to provide in vitro transcription (IVT) template linearized plasmids for mRNA vaccines and has supported several mRNA vaccine global enterprises to obtain clinical approvals. In terms of viral vector service, GenScript ProBio has a stable and high-yield viral vector platform.
Job Scope:
GenScript is seeking a highly motivated and scientifically rigorous (Sr) Analytical Research Scientist to join our RNA team. This position will play a pivotal role in the development and optimization of analytical methods for synthetic RNA, DNA, and formulation finished products, as well as in-process controls, raw materials, and new chemicals to ensure compliance with GMP standards.
Location: Redmond, WA
Responsibilities:
#GS
GenScript USA Inc/GenScript ProBio USA Inc. is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is the Company's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.
GenScript USA Inc./GenScript ProBio USA Inc. maintains a drug-free workplace.
