Senior/Principal Scientist, Formulation Development
Overview
STA Pharmaceutical Co., Ltd., a WuXi AppTec company (WuXi STA), is a global leading small molecule pharmaceutical development and manufacturing capability and technology platform company serving the life science industry, with operations in China and the United States. As a premier Contract Development and Manufacturing Organization (CDMO), STA offers our worldwide partners efficient, flexible and high-quality solutions for small molecule Active Pharmaceutical Ingredients (APIs) and finished dosage forms.
- A Leading Company of Contract Development and Manufacturing Organization(CDMO)
- The World’s Largest Process Chemistry Team
- to learn the most cutting edge technologies in the pharmaceutical development field
- to work with 200+ global new drug development companies
- Systemic and Multiple Training Programs(Technical/Soft skills/Management)
- Diversified Career Development and Promotion Trails
Responsibilities
- Work closely with line manager to meet project timelines, departmental goal, and customer requests.
- Work with Group Leader to perform formulation/process development, scale up and process optimization for Phase IIb/III, generic and LCM projects.
- Apply QbD related mindset and methodology into formulation and process development, scale up and post approval process optimization for all projects.
- Support scale up, technical transfer (site to site or PDS to site) and product control strategy translation to shop floor, making sure developed manufacturing process and PCS are capable of continuously manufacturing high quality drug product at commercial manufacturing site.
- Independently design experiments and conduct drug product development work with an awareness of state-of-the-art technology to support formulation and process development of drug product. Generate development plans, summaries and reports as needed.
- Provide technical leadership to the group and project team for the rapid resolution of technical issues during process development, scale up, technical transfer and post approval commercial manufacturing.
- Mentor and coach junior scientists in designing and implementing innovative solutions for assigned activities.
- Familiar with development process of new and generic drug product and relative regulations.
- Know-how and expertise in lab scale, pilot scale and production scale pharmaceutical equipment for oral solid dosage form.
- Help execute visions from upper management and provide feedback promptly.
- Compliant for lab and company’s policies.
Qualifications
- Skilled BS or MS degree, fresh Ph.D. degree in analytical chemistry, pharmaceutical analysis or other directly-related science discipline with experience or training in pharmaceutical products.
- Proven research skills as shown in scientific publications and hands on experience in pharmaceutical development projects.
- Good written and oral English. Good communicational and interpersonal skills.
- Good computer skills for MS Office, Chemdraw, data analysis and presentation. Must be customer-oriented and able to show flexibility and ability to work with multiple projects.
- Modern pharmaceutics theory esp. industrial pharmaceutics.
- Problem solving and trouble-shooting abilities.
Location: Pudong District, Shanghai City /Wuxi City, Jiangsu Province
Equal Opportunity Employer Minorities/Women/Veterans/Disabled
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