WuXi AppTec

  • Senior Scientist--Formulation Development

    Job Locations CN
    Job ID
    2018-3794
  • Responsibilities

    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.

    Qualifications

    Qualifications:

    • BS, MS or PhDs in industrial pharmaceutics or other directly-related discipline with 5+ years experience or training in formulation development as well as clinical product manufacturing.
    • Extensive experience in process development, process scale up, trouble shooting and process optimization of oral solid dosage form.
    • 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.
    • Skilled computer capabilities.
    • Work Capability : Candidates with extensive experience in process development, process scale up, trouble shooting and process optimization of oral solid dosage form are desired.
    • Leadership: Good presentation skills, creative thinking, good team player, plan and do the work independently.
    • Good interpersonal and cross functions communication skills.
    • Good project management skills.
    • Good problem solving skills and focus on details, execution and delivery.
    • Capability of fast learning and open minded to new initiatives.
    • Language: good written and oral communication skills in Mandarin and English.

    Equal Opportunity Employer Minorities/Women/Veterans/Disabled

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