Wednesday, April 16, 2014

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

          GROUP LEADER OF AUTORADIOGRAPHY

Responsibilities:

The Group Leader of Autoradiography will be an experienced autoradiography research professional who will lead a QWBA group to conduct studies as well as manage and participate in other preclinical ADME studies. The successful candidate will serve as a Study Director/Group Leader in the areas of Autoradiography and ADME.  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 Autoradiography and ADME; and ensure the staff fulfills their responsibilities in accordance with protocols, project contracts, and XBL policies, procedures, and SOPs.  This individual will also represent company in client interaction, 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 Chemistry, Biology, or a related discipline along with a minimum of 5 years hands-on, Autoradiography or related industrial experience, and advanced knowledge of Autoradiography/ADME concepts (ie. study design, current methods and validations, data interpretation, etc.). Candidate must be well versed in 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, proficient in a Microsoft Windows environment; and possess superior interpersonal, presentation, and organizational skills.

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           RESEARCH SCIENTIST

Responsibilities:

Conduct method development and validation of bioanalytical LC-MS/MS methods for quantification of drugs and their metabolites in biological samples (e.g., plasma, urine, tissues, etc); Lead effort with the study team to troubleshoot and solve assay development problems; Schedule and supervise method validation and 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 the company’s policies, procedures and SOPs; Be responsible for the technical conduct of a study, as well as for the interpretation, analysis, documentation and reporting of results from Watson LIMS system; Represents the single point of control for projects to ensure the compliance with SOP and FDA GLP regulations; Operate, calibrate and maintain critical analytical instruments, including HPLC/UPLC (Shimadzu/Waters), Mass Spectrometry (Sciex API4000/5000, Waters Xevo TQ-S) and automation (Janus, Tomtec).

Qualifications:

Must have a Ph.D. in Biochemistry, Environmental Chemistry, or Natural Products plus skills and knowledge in HPLC/UPLC (Shimadzu/Waters), Mass Spectrometry (Sciex API4000/5000), automation (Janus, Tomtec), bioanalytical LC-MS/MS methods, Watson LIMS, GLP/SOP.

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           QUALITY ASSURANCE AUDITOR

Responsibilities:

The Quality Assurance Auditor will have the responsibilities including but not limited to: inspecting/auditing analytical/bioanalytical studies performed according to Good Laboratory Practices (FDA, EPA, OECD); reviewing study data and reports; auditing software/system validation documents, summarizing findings and reporting to study directors/principal investigators and management; maintaining GLP-required documentation; keeping an accurate schedule of inspection activities; conducting facility, vendor and subcontractor audits.

Qualifications:

The successful candidate will have a BA/BS degree in a related scientific discipline and a minimum 2-yr QA experience working in a GLP-regulated environment; CRO experience is preferred.  Knowledge of government regulations related to clinical/non-clinical research is helpful. Candidate must be a fast learner who works well with numbers, is detail-oriented and highly organized, works well with people, and has excellent verbal and written communication skills.

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            STUDY DIRECTOR
            Pre-Clinical ADME

Responsibilities:

The Study Director of the Pre-Clinical ADME group will be an experienced professional who must have a thorough knowledge of study design, including in-life phase, sample processing, radioprofiling, Met ID, data analysis, and results interpretation.  The successful candidate will serve as a Study Director in the areas of ADME/PK studies.  The successful individual selected for this position will supervise Pre-Clinical projects; provide leadership in the delivery of services to clients; review work produced by project teams; have strong problem solving ability;  and ensure the staff fulfills their responsibilities in accordance with protocols, project contracts, and XBL policies, procedures, and SOPs.  This individual will also represent company in client interaction, 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, the successful candidate must have an Advanced degree or equivalent industrial experience  The individual must have deep knowledge and hands-on experience in dose preparation, animal dosing, sample collection, sample analysis, and sample processing techniques for mass balance PK and metabolite profiling/ID; knowledge in QWBA is helpful.  Prior experience in DEBRA LIMS is highly desirable.  Knowledge in laboratory animal care and facility management, as well as IACUC function, is highly desirable.  Candidate must be well versed in drug discovery and development, etc. as well as extensive protocol and report writing experience.  The successful candidate must be hands-on, well organized, and a team player.  Candidate must also be detailed-oriented, proficient in a Microsoft Windows environment; and possess superior interpersonal, presentation, and organizational skills.

 

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             STAFF ACCOUNTANT

Responsibilities:

The Staff Accountant will be responsible for assisting the Controller and the organization’s accounting functions. These functions include maintaining the organization’s accounting principles, practices, procedures, and initiatives. The successful individual will have the responsibility to prepare journal entries in conjunction with the monthly closing; monthly reconciliations; updating and maintaining corporate records; prepare financial reports and present findings; assist in Controller’s job duties; regularly analyze account balances to ensure accuracy and proper accounting treatment; and assist with cash and banking transactions. This position will also report to and assist the HR department with administrative functions as required.

Qualifications:

The successful candidate must possess a Bachelor’s degree in Accounting/Finance, have a minimum of 1-3 years experience, strong communication skills (verbal and written), ability to multi-task in a fast-paced and team oriented environment, ability to exercise good judgment by recognizing urgency and prioritizing accordingly, high degree of confidentiality and latitude, advanced knowledge of spreadsheet applications and solid computer skills, and able to work independently with strong administrative and problem solving skills. The successful individual will also have experience with Sage MAS 90 Software and a background in cost accounting is a plus. Microsoft Word, Excel and Power Point are required.

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    IT SPECIALIST

Responsibilities:

The major responsibilities of the IT Specialist include installing/rebuilding/migrating existing serves and configuring hardware settings, directories, etc. in accordance with standards project/operational regulations, developing/maintaining installation and configuration procedures, and researching/recommending innovative, and where possible, automated approaches for system administration tasks. The individual will be performing daily backup operations, ensuring all required file systems and system data are successfully backed up to the appropriate media, recovery tapes or disks are created, and media is sent off site. The IT specialist will also be repairing /recovering are hardware or software failures, coordinating/communicating with impacted departments, managing virtual severer, securing/documenting/auditing servers and networks according to Best Practices, and supporting Validated Scientific Applications such as LIMs and acquisition software. Desktop support/maintenance, asset, patch, and change management, Network Security including vulnerability testing and virus remediation, participating on validation teams, performing change controls and Employee On boarding or Termination Procedures are also part of the IT Specialist’s duties.

Qualifications:

The successful candidate must possess a Bachelor’s of Science degree, have a minimum of 5 years experience and 2 years experience in the Pharmaceutical or a GLP environment, be trained in Windows Server 2003 R2 / 2008 R2 / 2012, Microsoft Exchange 2003 / 2013, Active Directory Management and Network Management/Security, and VMware Virtualization. He or she must also have the Ability to communicate orally and write in a professional manner, work well both alone or in a team setting and have excellent Project/Time Management Skills. Training and experience in data acquisition and LIMS systems, demonstrating the ability to learn new technologies quickly, and familiarity with FISMA, FIPS 199, SANS Top 20, Federal Desktop Core Configuration and 21 CFR11, 21 CFR 58, GLP is preferred.

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Ongoing Positions

ASSISTANT/ASSOCIATE SCIENTIST
Preclinical Research

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

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

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

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)

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

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

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.

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

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.

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

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

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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