WuXi AppTec

Group Leader/Associate Director of Large Molecule

US-NJ-Plainsboro
Job ID
2017-3074

Overview

Xenobiotic Laboratories (XBL), a subsidiary of the Lab Testing Division of WuXi AppTec, Inc., is a leading contract research laboratory specializing in small molecule bioanalytical, drug metabolism, and pharmacokinetic services to the pharmaceutical, animal health and agrochemical industries.  XBL is seeking an  Group Leader/Associate Director of Large Molecule Quantitative Bioanalysis located in our Plainsboro, NJ location.

Responsibilities

Primary Duties and Responsibilities:

  • Leads PK and Biomarker teams to conduct preclinical and clinical PK method development, qualification, validation and sample analysis.  Plans, schedules, and coordinates studies with department head, staff, and sponsors.
  • Acts as principal investigator and project manager to coordinate and conduct large molecule quantitative bioanalytical studies and duties.  Develops, improves, and validates methods and/or SOPs according to the most up-to-date FDA Guidance and sponsor requirements.
  • Guides PIs to manage studies through study plan, method, data processing, report, trouble shooting, investigations, and method performance trending.  Trains scientists on laboratory skills and operation procedures.
  • Functions as expert large molecule consultant to staff, management, and clients.  Presents summaries of work to peers, management, and clients. 
  • Assumes ownership of department instruments.  Assists and coordinates department instrument qualification and validation.  Provides recommendations to management on procurement of equipment and materials.  Maintains, calibrates, and troubleshoots instrumentation.  Manages, archives, and maintains all data generated from operations. 
  • Strong understanding of Good Laboratory Practices and relevant quantitative LBA regulatory guidance.  Implements GLP and other pertinent regulatory requirements as called for by study protocols.
  • Maintains large molecule research services facility at state-of-the-art level in accordance with company goals. Maintains and ensures laboratories safe workplace and regulated environment. Provides input to management concerning biological research and operation issues.
  • Assists and collaborates with other LM BAS group leaders and management on daily operation and team development.
  • Other duties as assigned.

 

 

 

Qualifications

Experience / Training / Education:

  • D. or M.S. degrees in biology or related fields, or equivalent
  • 5-8 years of hands-on industrial experience with quantitative bioanalysis operations in a GLP facility, or equivalent. CRO experience is a plus.
  • Any similar combination of education and experience

 

Knowledge / Skills / Abilities:

  • Expert working knowledge and leadership ability in large molecule quantitative bioanalysis field, with ability to conduct challenging studies under limited supervision
  • Knowledge and experience of commonly used scientific concepts, practices, and procedures within the pharmaceutical R&D industry. Ability to research and evaluate data and research results
  • Thorough understanding of regulatory guidance and adherence to regulatory guidelines and SOP requirements on regulated bioanalysis
  • Well organized, detail oriented, and adaptable to changes. Ability to work under pressure of multiple projects and deadlines.  Ability to effectively prioritize workload and manage changes in direction
  • Effective oral and written communication skills. Effective interpersonal skills
  • Software expertise: MSD Discovery Workbench, SoftMax Pro GxP, Watson LIMS, etc.
  • ELN experience a plus
  • LC-MS/MS bioanalysis of large molecule is a big plus 


Equal Opportunity Employer Minorities/Women/Veterans/Disabled

 

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