Overview

　　This position fulfils the desire of Senior Management to increase the overall level of leadership capability at Bioanalytical Services (BAS), Plainsboro, New Jersey (NJ). The incumbent will provide leadership for the performance of the Small Molecule, Large Molecule and Central Lab functions at the WuXi NJ site, lead the team in bioanalytical sciences, GLP operations, and business aspects, and to collaborate with WuXi’s Bioanalytical and Central Labs in China to promote synergy in supporting global clinical and non-clinical studies.

　　Responsibilities

　　Serve as a key subject matter expert of bioanalysis (BA) in Global WuXi Bioanalytical Services (gBAS)

　　Possess in-depth knowledge about bioanalytical sciences, GLP/GCLP regulations, bioanalytical guidelines,

　　Could serve as the lead at the New Jersey (NJ) site of WuXi AppTec to promote bioanalytical sciences in the BA society, facilitate customer facing activities, and to grow the scientific capabilities at the NJ site,

　　Have overall responsibility to manage scientific and GLP/GCLP compliance at the NJ site, which includes GLP operations for the BAS facility under Good Laboratory Practice principles to meet regulatory agency requirements

　　Coordinate and provide leadership for the Bioanalytical and Central Lab teams at the New Jersey site in scientific, operations, and business aspects, to promote productivity and increase efficiency,

　　To work with Quality Assurance (QA) and Quality Control (QC) teams to promote and ensure compliance with GLP/GCLP, CLIA, and other applicable regulations, to provide high quality services

　　Work with other TFM members for good support of the GLP studies

　　Work with the WuXi gBAS teams from various sites to promote synergy and growth

　　Effectively communicate and work with business partners to ensure timely completion of the projects with high quality to best support clients’ needs

　　To provide leadership for the bioanalytical and central lab projects, to be accountable for quality deliverables of the projects.

　　Continue to improve the overall operation of the NJ BAS including implementing new technologies, optimizing processes, timely SOP revision and addition to meet high quality bioanalytical GLP facility requirements and assure regulatory compliance

　　Provide leadership, mentorship, and training to internal staffs

　　Develop the team to maintain high level of scientific rigor, lead the efforts in establishing effective training curriculum for team growth

　　Develop new business and promote business growth for the NJ Bioanalytical and Central labs

　　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:

　　D. or Master degree in Bioanalytical, pharmaceutical, immunology, biological sciences, or a related field

　　15 years of industrial experience in bioanalytical services in support of clinical studies

　　Strong experience and knowledge in bioanaytical sciences, an expert in bioanalytial tests, including PK, PD, and immunogenicity studies

　　Strong track records in leadership and people management

　　Strong experience and knowledge on GLP regulations, and pertinent regulations on bioanalytical sciences

　　Strong experience and track records in hosting GLP inspections

　　Strong experience on operation in supporting GLP studies

　　Experience in promoting business growth

　　Full time on NJ site

　　Knowledge / Skills / Abilities:

　　Strong knowledge and an expert on bioanalytical sciences.

　　Strong knowledge on GLP/GCLP regulations

　　Strong leadership skill

　　Strong and effective oral and written communication skills and excellent interpersonal skills

　　Good to have knowledge in clinical chemistry analysis, hemanalysis, urinalysis, coagulation, biochemistry, hemoglobin testing, immunoassays, and associated testing platforms

　　Good to have knowledge on CAP and CLIA regulations

　　Well organized, detail oriented, and adaptable to changes

　　Well-developed management skills

　　Ability to work under pressure of timeline and milestones

　　Ability to effectively prioritize workload and manage changes in direction

　　Promote team work, a good team player

　　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

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　　Job Locations US-NJ-Plainsboro

　　Job ID 2024-12502