Global recruitment of Chief Analytical Scientist

1. Job Summary

The Chief Analytical Scientist will be responsible for product quality research and analysis in drug development. Through in-depth understanding and analysis of disease control requirements, market demands, and the latest technological developments, you will be responsible for formulating and executing pharmaceutical analysis R&D strategies. You will lead teams in developing and validating analysis methods, ensuring drug quality, and contributing to the writing and review of drug registration materials to advance the new drug development process.

2. Roles and Responsibilities

1. Lead and support the development of analytical methods for biopharmaceuticals (including vaccines, antibodies, CGT, etc.), advancing products from preclinical to clinical stages.
2. Guide the team in various chemical-physical or biological functional analyses for sample testing and support biomolecule development.
3. Write, review, and approve SOPs, experimental methods, and reports. Support the design of non-clinical and clinical research protocols, and data analysis.
4. Lead or participate in studies supporting the CMC development of biopharmaceuticals, including CQA assessments, comparability studies, and detailed characterization of biopharmaceuticals’ properties to understand products and processes. Assist with the preparation of source documents, including regulatory submissions, and facilitate the submission of various regulatory CMC documents.
5. Provide guidance and mentorship for the team.

3. Qualification and Requirements

1. Doctoral degree in pharmacy, chemistry, analytical chemistry, or biochemistry with at least 6 years of biopharmaceutical experience in industry; or an experienced master’s degree holder with over 10 years of biopharmaceutical experience in industry.
2. Proficient in analytical testing methods including physicochemical properties, content, purity and impurities, biological activity, and immunological effects. Experienced in the development, optimization, validation, and transfer of analytical methods. Well-versed in process development and comparability studies. Experienced in the full lifecycle management of analytical methods.
3. Capable of independently designing experiments and making informed improvements based on results, with a strong aptitude for scientific thinking and logical judgment. Skilled in problem solving through project experience.
4. Possess systematic domain expertise and strong experimental skills, capable of leading team members to complete major projects.
5. Experienced in experimental design, development, optimization, and problem solving. Knowledgeable of CMC-related regulatory requirements (FDA, EMA, NMPA, ICH). 
6. Fluent in English, able to research English academic literature.

About SINOVAC

Sinovac Biotech Ltd. (SINOVAC) is a Chinese biopharmaceutical company that focuses on the R&D, manufacturing, and commercialization of vaccines and antibodies. SINOVAC also produces other preventive and therapeutic products that protect against human infectious diseases.

SINOVAC is dedicated to addressing major challenges in disease prevention and treatment through cutting-edge technology. We focus on unmet medical needs regarding infectious disease and other significant therapeutic areas. All our work integrates cutting-edge research and major findings from across the world, concentrating strengths to develop first-in-class biopharmaceuticals such as vaccines, antibodies, and fusion proteins, ensuring high-quality products reach the market swiftly. Our high R&D standards are backed by innovation-driven platforms such as the United Research Institute of SINOVAC (URIS) for drug discovery and our product-oriented CMC platform. We also run clinical demand support platforms such as our Analysis Center and Animal Center for Drug Evaluation. Our world-class facilities mean we have a mature system for developing preventive and therapeutic products, with multiple types of technologies including our own core technologies. Our multidisciplinary research team, covering fields such as pharmacy, biology, medicine, and chemistry, are at the forefront of global research and innovation.

Going forward, SINOVAC will promote both the research and industrialization of biopharmaceuticals. While continuing to develop its vaccine industry, we will also expand our markets in therapeutic monoclonal antibodies, gene therapy, and cell therapy. Through independent R&D, collaboration, and external investment, we will accelerate the industrialization of high-quality biopharmaceuticals to fulfil global disease prevention and control, improving global health and well-being.

Since being founded in 2001, our mission has been to “supply vaccines to eliminate human diseases”. SINOVAC has developed a comprehensive portfolio including vaccines against common infectious diseases like hepatitis virus, seasonal influenza, pneumococcal disease, poliomyelitis, varicella, and mumps, as well as emerging ones, such as COVID-19, enterovirus71 (EV71) related Hand-Foot-Mouth disease (HFMD), H5N1 influenza (avian flu), H1N1 influenza (swine flu) and SARS.

Thanks to its comprehensive quality management, SINOVAC has four vaccines approved by the World Health Organization (WHO). Its hepatitis A vaccine Healive®, Sabin-strain inactivated poliomyelitis vaccine (sIPV), and varicella vaccine were granted WHO prequalification (“PQ”); and its COVID-19 vaccine CoronaVac® was validated by the WHO under the Emergency Use Listing (“EUL”) Procedure.