Overview

　　The Sr. Scientist/Lab Manager will hold the role inclinical safety testing under CLIA/CAP guidelines. Willlead and operate theclinical testing Lab, providing high quality safety testing data to support pharma’s and biopharma’s, maintaining a high level of scientific achievements.

　　Responsibilities

　　Essential Job Functions:

　　Lead the clinical chemistry and immunoassay function for Central Lab in the New Jersey site of WuXi AppTec. Use its quality system and state-of-art testing platforms to provide high quality services..

　　To comply with CLIA/CAP 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. Includes business partners, internal Quality Assurance and external regulatory authorities in order to fully comply with CAP, CLIA and other pertinent regulatory.

　　Maintain high level of scientific rigor.

　　Prepare, review or approve assay validation and reports

　　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 staff.

　　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.

　　Qualifications

　　Experience / Education:

　　Masters or Bachelor degree in biology, chemistry, medical laboratory science, or a related field in clinical chemistry and/or immunoassay testing. – PH.D helpful

　　5 years of for Master, >7 years for Bachelor industrial experience in Central Lab services in support of clinical studies.

　　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 on applying and maintaining CLIA and CAP certificates.

　　Strong experience in hosting CLIA and CAP inspections

　　Experience of managing a team

　　Any similar combination of education and experience.

　　Knowledge / Skills / Abilities:

　　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

　　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

　　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

　　This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.

　　Need help finding the right job?

　　We can recommend jobs specifically for you!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 disabilityAn 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 (https://careers-wuxiapptec.icims.com/connect?back=intro&findajob=1&in_iframe=1&hashed=-435740542)

　　Job Locations US-NJ-Plainsboro

　　Job ID 2023-12490