Monday, September 06, 2010

Employment opportunities

Open Positions
Ongoing Positions*

*A note about ongoing positions:
These are positions for which XBL maintains an open enrollment policy. These are not currently open positions, however, XBL will contact candidates (whose information we have on file) that are a good match in the event that one of these positions opens up.

Open Positions

ANIMAL SCIENCE STUDY DIRECTOR/GROUP LEADER

Responsibilities:
XenoBiotic Laboratories, Inc. (XBL), a GLP-regulated Pharmaceutical Development Contract Research Organization located in central NJ, is seeking an experienced animal research professional to lead the in-life group to conduct preclinical ADME/PK/PD studies and maintain the animal facility. The successful candidate will serve as a Study Director/Group Leader in the areas of animal/in-vivo mass balance and PK and PD studies. The successful individual selected for this position will supervise preclinical projects; provide leadership in the delivery of services to clients; review work produced by project teams; has strong problem solving ability; initiate, plan, and implement staff development programs related to animal research; and ensure the staff fulfills their responsibilities in accordance with protocols, project contracts, and XBL policies, procedures, and SOPs. This individual will also be responsible for taking a lead role in the day-to-day management of major studies and ensuring that projects are delivered on time, within budget, and according to client expectations.

Qualifications:
In addition to demonstrating a thorough understanding of scientific principles and GLP regulations, successful candidates must possess an advanced degree (Ph.D. preferred) in Pharmacology, Biology, Laboratory Animal Science, or a related discipline along with a minimum of 8 years experience conducting animal mass balance and PK studies in a CRO environment. The individual must be proficient in dose preparation, animal dosing, sample collection, sample analysis, and sample processing techniques for rodents and dogs. Knowledge in laboratory animal care and facility management, as well as IACUC function, is a must. Candidate must have a thorough knowledge of drug discovery and development, etc. as well as extensive protocol and report writing experience. The successful candidate must be hands-on, with supervisory experience, a good trainer, well organized, and a team player. Candidates must also be detailed-oriented with strong problem-solving skills and a collaborative, team-oriented approach; computer proficient in a Windows environment; and possess superior interpersonal, presentation, and organizational skills.

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PROJECT MANAGER

Responsibilities:
The Project Manager will work in the bioanalytical chemistry, area. Individuals selected for this position will schedule and supervise method validation, sample analysis for preclinical and/or clinical projects, provide leadership in the delivery of services to clients; review work produced by project teams; ensure staff fulfills their responsibilities in accordance with project contracts and XBL policies, procedures and SOPs. They will also be responsible for taking a lead role in the day-to-day management of major studies; ensure that projects are delivered on time, within budget and according to client expectations.

Qualifications:
Successful candidates must at minimum, possess an undergraduate degree in a clinical or health related field: advanced degree preferred, along with a minimum 3-5 years experience as a Project Manager with a CRO or Pharmaceutical company. Prior hands on laboratory experience in bioanalytical sample analysis is highly desirable. This position also requires a minimum of 3 years of experience in project scheduling, and resource/ budget management, team activity coordination and client interaction/management. Experience with the full clinical development process through regulatory submissions is a plus. This position requires candidates to be detailed-oriented, computer proficient in a Windows environment and possesses superior interpersonal and organizational skills.

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Ongoing Positions

ASSISTANT/ASSOCIATE SCIENTIST
Preclinical Research

Scope of Responsibilities
  • Under supervision of senior scientist, participate in preclinical study related activities including animal care, dosing, sample collection, processing and analysis for rodent and non-rodent preclinical studies
  • Perform data analysis, data checking, report preparation and instrument/assay set up, operation and maintenance
General Qualifications
  • A.S. or B.S. degree in biology, animal science, or related discipline
  • Experience or knowledge in animal handling or animal care is desirable but not necessary; training available
  • A certificate of LAT or above is a plus

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CHEMIST/ASSOCIATE SCIENTIST
Drug Metabolism/Environmental/Pharmaceutical Chemistry Areas

Scope of Responsibilities
  • Preparation of biological samples
  • Performs routine analytical chemistry assays
  • Instrument set up, operation, and maintenance
  • Support senior staff with experiment set up and execution
General Qualifications
  • Experience in/knowledge of chromatography, sample preparation, wet chemistry, isolation/separation, and radiotracer techniques is desirable
  • Working in a regulated environment, following SOPs and adhering to pertinent regulations including Good Laboratory Practices (GLP)
  • BS or MS in science (chemistry, biochemistry, or related discipline)


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QA SPECIALIST (various levels)

Scope of Responsibilities
  • Inspect/audit research studies to assure compliance with both government regulations and federal guidelines as well as with company policies
  • Audit/inspect laboratory studies, review data, write reports and summarize results from inspections/audits, and assist in overall functions of QA
  • Maintain written records of inspections/audits and do follow-up to verify that any corrective action required has been implemented
  • Assist in writing/updating standard operating procedures
  • Support scientific staff through participation in training and orientation presentations
  • Interact with Sponsors through site visits and requests for information
General Qualifications
  • BA/BS degree in related scientific discipline or equivalent experience
  • Experience working in a GLP/GMP or GCP regulated research environment
  • Knowledge of government regulations related to clinical/non-clinical research is helpful
  • Enjoy working with numbers, detail oriented and highly organized.
  • Skilled in written and verbal communication, excellent interpersonal skills
  • Prior laboratory and QA experience is highly desirable, but training will be provided
  • Good math and computer skills (MS Word/Excel)

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RESEARCH SCIENTIST PHARMACOKINETICS

Scope of Responsibilities:
  • Responsible for PK/TK analysis and report writing in support of client sponsored preclinical and clinical projects.
  • The successful candidate must have hands on experience with PK analysis software such as WinNonlin, and must be familiar with ADME studies in drug development.
General Qualifications
  • Requirements - Ph.D. in Pharmacokinetics or related field with 1-2 years industrial experience or MS with 7+ year's relevant industrial experience.
  • Strong written and verbal skills, highly organized, excellent computer skills, strong interpersonal and communication skills required.
  • Prior experience in CRO is highly desirable.

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RESEARCH SCIENTIST PRE-CLINCIAL GROUP

Scope of Responsibilities:
  • Serve as study director while working closely with in-life technical support staff and members of the metabolism group.
  • Design study protocols, participate in study initiation/dosing, supervise study conduct, and write study reports, as well as communicate with sponsors as primary contact person.
General Qualifications
  • Strong written and verbal skills, highly organized, excellent computer skills, strong interpersonal and communication skills.
  • The successful candidate must have superior multitasking skills, be able to manage multiple projects, and meet project timelines.
  • Must be familiar with ADME studies in drug development, current industry guidance's, and worldwide GLP regulations.
  • Requirements - Ph.D. in Pharmaceutical Science, Pharmacology, Biochemistry, Medicinal Chemistry, Toxicology or related field and 4+ years relevant hands-on industrial experience,
  • Prior experience in CRO is highly desirable.

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STAFF SCIENTIST/RESEARCH SCIENTIST
Mass Spectrometry Group

    Scope of Responsibilities
    • Utilize existing analytical methods in the LC/MS analysis of drug entities
    • Daily operation and instrument maintenance and troubleshooting
    • Develop and validate new and challenging analytical methods for new chemical entities
    • May serve as Study Directors/Principal Investigators
    • Data summary and report writing
    General Qualifications
    • Experience in analytical method development/validation using mass spectrometry and spectral data interpretation
    • Experience in operating the modern quadrupole mass spectrometers, such as the Sciex API 4000 series, to analyze organic, organometallic and biological samples
    • Knowledge of all aspects of assay development including sample extraction and preparation, and chromatography
    • Working in a regulated environment, following SOPs and adhering to pertinent regulations including Good Laboratory Practices (GLP)
    • Excellent organizational and communication skills, work independently
    • PhD/MS in chemistry, mass spectrometry or related field and 1-4 years of experience preferred. Candidates with a B.S and 4-6 years of experience in assay method development and operation of LC/MS will also be considered

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