Associate Director, Central Lab

Company: WuXi AppTec
Location: Plainsboro
Posted on: November 18, 2023

Job Description:

Summary:

• Leading the Central Lab, providing high quality safety testing, kits production, and logistic services to world-class pharmas and biopharmas
• Establish and maintain business relationship with worldwide companies
• Effectively communicate and interface with business partners, internal Quality Assurance and external regulatory authorities in order to fully comply with CAP, CLIA and other pertinent regulations.
• Develop and maintain high level of scientific achievements for the central lab. Be expected to be the point of contact for project coordination, including scientific and business interaction with customers.
• Serve as an internal expert to design, develop and validate assays in supporting clients' needs, direct consumable, sample, and logistic services for clients
• Prepare, review or approve assay validation and reports
• Provide training and mentorship to internal staffs
• Develop new business and promote business growth for the Central lab
  Essential Job Functions:
  • Lead the Central Lab in the New Jersey site of WuXi AppTec, in both scientific and business aspects, to coordinate and collaborate with WuXi's Central Lab in China to form WuXi's global central lab network to spearhead logistics as well as testing in supporting global clinical studies
  • To lead the clinical chemistry and immunoassay lab, use its quality system and state-of-art testing platforms to provide high quality services to word-class pharmas and biopharmas
  • To comply with CLIA regulations, provide high quality services to clients, meet and exceed clients' expectation, effectively communicate to ensure customer's satisfaction
  • Effectively communicate and work with business partners to ensure timely completion of the projects, and to best support clients' needs
  • Work with Quality Assurance and regulatory authorities in order to fully comply with CLIA and other pertinent regulations.
  • Develop the team, participate in scientific community activities, and to maintain high level of scientific rigor.
  • To be responsible for central lab projects, to be accountable for quality deliverables of the projects.
  • To be the internal expert for assay design, development and validations, and reports
  • Provide training and mentorship to internal staffs
  • Develop new business and promote business growth for the Central lab
  • Promote implementation and compliance with WuXi AppTec, Inc. safety policies, -practices, and procedures in order to maintain a safe work environment and -minimize or eliminate injury.
  • Other duties as assigned
    Experience / Education: - -
    • D. or Master degree in clinical chemistry and/or immunoassay testing, pharmaceutical sciences, immunology, biology or a related field
    • > 5 years of industrial experience in Central Lab services in support of clinical studies and clients' needs
    • Strong experience and knowledge in Central Lab testing, an expert in clinical chemistry analysis, hemanalysis, urinalysis, coagulation, biochemistry, hemoglobin testing, immunoassays, and associated testing platforms.
    • Strong experience and familiar the process of applying and maintaining CLIA certificates
    • Strong experience in Central laboratory operations
    • Experience of directly managing a group of at least 5 staff
    • Rich experience in project management -Knowledge / Skills / Abilities:
      • Strong working experience in Central Lab, understand Central Lab business, with good track record in central lab serves
      • Strong knowledge in clinical chemistry analysis and immunoassays
      • An expert in clinical chemistry analysis, hemanalysis, urinalysis, coagulation, biochemistry, hemoglobin testing, immunoassays, and associated testing platforms
      • Strong knowledge in CAP, and CLIA regulations
      • Familiar with pharmaceutical R&D process and Central laboratory operations
      • Well organized, detail oriented, and adaptable to changes
      • Well-developed management skills
      • Effective oral and written communication skills and excellent interpersonal skills
      • Ability to work under pressure of timeline and milestones
      • Ability to effectively prioritize workload and manage changes in direction
      • Ability to work in a team environment
      • Good knowledge and understanding in project management
      • Strong communication skills and ability to interact with people
      • Bilingual, fluent in both Chinese and English (written and oral) is preferred, -Physical Requirements:
        • Well organized, detail oriented, and adaptable to changes
        • Able to travel for business as needed
        • Must be able to work in an office environment with minimal noise conditions.
        • Must be able to work in Lab setting with exposure to Animals/biohazards / Chemicals (List specific Chemicals)
        • Must be able to wear appropriate PPE
        • Must be able to work in environment with variable noise levels
        • Ability to stand /Sit/walk for long periods of time
        • Ability to crouch, bend, twist, and reach
        • Clarity of Vision
        • Ability to identify and distinguish colors
        • Must be able to perform activities with repetitive motions
        • Ability to work in variable temperatures high to freezing - -An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability -

Keywords: WuXi AppTec, Trenton , Associate Director, Central Lab, Executive , Plainsboro, New Jersey