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 biopharmasEstablish 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 clientsPrepare, review or approve assay validation and
reportsProvide training and mentorship to internal staffsDevelop
new business and promote business growth for the Central
labEssential 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 biopharmasTo comply with CLIA
regulations, provide high quality services to clients, meet and
exceed clients' expectation, effectively communicate to ensure
customer's satisfactionEffectively communicate and work with
business partners to ensure timely completion of the projects, and
to best support clients' needsWork 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
reportsProvide training and mentorship to internal staffsDevelop
new business and promote business growth for the Central labPromote
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
assignedExperience / 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' needsStrong 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
certificatesStrong experience in Central laboratory
operationsExperience of directly managing a group of at least 5
staffRich experience in project management -Knowledge / Skills /
Abilities:
Strong working experience in Central
Lab, understand Central Lab business, with good track record in
central lab servesStrong knowledge in clinical chemistry analysis
and immunoassaysAn expert in clinical chemistry analysis,
hemanalysis, urinalysis, coagulation, biochemistry, hemoglobin
testing, immunoassays, and associated testing platformsStrong
knowledge in CAP, and CLIA regulationsFamiliar with pharmaceutical
R&D process and Central laboratory operationsWell organized,
detail oriented, and adaptable to changesWell-developed management
skillsEffective oral and written communication skills and excellent
interpersonal skillsAbility to work under pressure of timeline and
milestonesAbility to effectively prioritize workload and manage
changes in directionAbility to work in a team environmentGood
knowledge and understanding in project managementStrong
communication skills and ability to interact with peopleBilingual,
fluent in both Chinese and English (written and oral) is preferred,
-Physical Requirements:
Well organized, detail oriented, and
adaptable to changesAble to travel for business as neededMust 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 PPEMust be able to work in environment
with variable noise levelsAbility to stand /Sit/walk for long
periods of time Ability to crouch, bend, twist, and reachClarity of
VisionAbility to identify and distinguish colorsMust be able to
perform activities with repetitive motionsAbility 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, Healthcare , Plainsboro, New Jersey
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