Overview

　　Supervise personnel on Large Molecule Bioanalysis (LM) and be a Subject Matter Expert on ADA and Nab assays. Responsible for scientific and technology development to ensure the successful implementation of the ADA and Nab assays in order to deliver outstanding customer satisfaction. Oversee and direct multiple projects concurrently and is accountable for managing team resources for project execution and delivery on time with quality.

　　Responsibilities

　　Supervise personnel associated with bioanalysis in large molecule BAS group. Ensures optimum personnel performance through leading by example, motivation and performance recognition.

　　Responsible for evaluating new technology in the field of large molecule bioanalysis, which include but not limited to ADA, (cell based) NAb, and other antibody related analytical testing.

　　Prepares high quality reports and study summaries for management and sponsors.

　　Functions as a study director, principal investigator, or project coordinator including serving as a primary contact for sponsors. Responsibilities include planning and supervising more complex and exacting research studies.

　　Actively participate in lab operation efficiency improvement efforts and promote team work and collaboration.

　　Maintains effective cost control within the LM bioanalytical group through implementation and maintenance of efficient and effective work scheduling coupled with creative and well thought out study planning and design.

　　As a department management team member, assists site top management for overall functions and operation in bioanalysis and other departments. Ensures compliance with company safety policies, practices, and procedures in order to maintain a safe work environment and minimize or eliminate injury.

　　Maintains close professional contact with updated regulatory guidance and industry developments in all critical analytical areas to ensure that laboratory functions operate at state-of-the art level and are compliant with all pertinent Good Laboratory Practices (GLP).

　　Promotes company’s safety policies, practices and procedures in order to maintain a safe work environment.

　　Other duties as assigned.

　　Qualifications

　　Experience / Education:

　　D. degree in biology, biochemistry, molecular biology, immunology, or equivalent

　　10 years of relevant experience in large molecule bioanalysis, drug development, or equivalent

　　3-5 years of people management experience

　　Any similar combination of education and work equivalent experience

　　Knowledge / Skills / Abilities:

　　Expert knowledge of biological sciences

　　Expert knowledge of commonly used scientific concepts, practices, and procedures within large molecule analytical/bioanalytical field

　　Expert in immunoassay and other relevant techniques for large molecule analysis, in addition to appropriate regulatory guidelines

　　A thorough understanding of the services provided by CROs

　　Well organized, detail oriented, and adaptable to changes

　　Effective oral and written communication skills

　　Excellent interpersonal skills

　　Ability to research and evaluate applicable types of data and research results

　　Computer skills: skilled at internet research, MS Word, Excel, Outlook, PowerPoint, and Watson LIMS. Microsoft Project knowledge a plus

　　Ability to work under pressure of multiple projects and deadlines

　　Ability to effectively prioritize workload and manage changes in direction

　　Ability to work in a team environment

　　Familiarity with and adherence to regulatory guidelines consistent with site requirements

　　Physical Requirements:

　　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 not have animal allergies to applicable species in this facility

　　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

　　Ability to push/pull 10 lbs occasionally

　　Clarity of Vision

　　Must be able to perform activities with repetitive motions

　　Inside working conditions

　　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 2024-12532