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Senior Associate Scientist/Scientist/Senior Scientist
Requisition ID: 1805652562W
Janssen Research & Development LLC, a member of the Johnson & Johnson family of Companies, is recruiting for a Scientist position, located in Shanghai, China
Janssen Research & Development, L.L.C. develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The candidate will be the Subject Matter Expert (SME) of microbiological assays within JNJ PDMS Shanghai lab and responsible for the development/co-development, validation and transfer of microbial assays for global projects as well as for China local projects. The candidate will provide technical project support, lead projects, review lab notebooks, present data to technical teams and mentor junior scientists. The candidate will also work closely with internal colleagues and external partners to ensure a smooth knowledge and method procedure transfer. The individual will be expected to maintain laboratory notebooks in a GXP compliant manner, prepare study protocols, reports and SOPs and contribute to regulatory filings.
A minimum of a MS degree in Microbiology, Biology or related field with more than 3-year microbial laboratory experience or a BS degree with more than 6 years relevant experience is required.
· In-depth knowledge with the microbial testing and microbial method validation is required.
· Extensive hands-on laboratory experience in pharmaceutical industry with microbiological testing such as sterility/bioburden, LAL testing, microbial identification, gram staining, purified water testing as per USP, EP and ChP, bacteriostasis and growth promotion assay is required.
· Experience with GMP laboratory operations and FDA regulations is required.
· Experience in environmental monitoring of clean room, aseptic media fill evaluation and writing annual/quarterly reports for Environmental Monitoring and water trending reports is preferred.
· Ability to work in a cross functional team environment is required.
· Experience of working with CRO is preferred.
· This individual must have excellent verbal and written communication skills in both English and Chinese.
· This position may require up to 10% domestic or international travel. This position will be located in Shanghai, China.
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J&J (China) Investments Ltd (7046)