CEDRA CORPORATION, located in Austin, Texas, providing biotechnical services to the pharmaceutical/biotechnical industries and the Federal government has the following position available.
Method Development Team Leader:
This position will oversee all small molecule LC-MS-MS bioanalytical method development. The teams are responsible for the development, validation and application of assays for the quantitation of small molecules from a variety of biological matrices (i.e. plasma, urine, whole blood) to support preclinical and clinical studies. Method Development Team Leader oversees the selection, development, implementation, and qualification of suitable small molecule bioanalytical methods consistent with current and emerging regulatory expectations. Supervises method development and LC-MS/MS instrument operations teams consisting of Ph.D, M.S. and B.S/A. chemists. Consult with business development on project feasibility, budgeting and timing. Provides education, guidance, and leadership to method development chemists and project teams. Contributes to project teams as a functional expert in troubleshooting of bioanalytical LC MS/MS assays and unexpected event investigations. Develop capabilities and resources to meet both present and future needs.
RESPONSIBILITIES:
- Oversees the selection, development, implementation, and qualification of suitable small molecule bioanalytical methods consistent with current and emerging regulatory expectations
- Supervises method development and LC-MS/MS instrument operations teams consisting of Ph.D, M.S. and B.S/A. chemists
- Consult with external clients on drug discovery or method development needs
- Consult with business development on project feasibility, budgeting and timing
- Provides education, guidance, and leadership to method development chemists and project teams
- Contributes to project teams as a functional expert in troubleshooting of bioanalytical LC‑MS/MS assays and unexpected event investigations
- Stays abreast of current relevant scientific and technical literature and industry trends
- Develop capabilities and resources to meet both present and future needs.
EDUCATION, EXPERIENCE AND SKILLS:
- Bachelors in science related field
- Knowledge and experience in bioanalytical methods development required
- Knowledge and experience of performing validation studies and method development work in accordance with GLP and other regulatory guidance required
- Experience with biological sample clean-up including SPE, LLE, protein precipitation and SLE techniques
- Experience developing and performing bioanalytical assays (e.g. HPLC, UPLC, LC‑MS/MS, a variety of drug, biomarker, PK, etc.) required
- Fluency in the use of specialized (Analyst®, Waston LIMS ®, etc.) and standard (MS Word, MS Excel, MS PowerPoint) computer software required
- Understanding and application of industry documentation practices, including GLP, essential
- Demonstrated ability to communicate, present information, and derive appropriate conclusions using scientific data required
- An established leader with strong interpersonal and leadership skills
Award winning benefits package includes Medical, Dental, Vision, 401K, revenue incentive plan, and onsite childcare.
Fax, e-mail or mail resume to:
CEDRA Corporation
Human Resources Dept.
8609 Cross Park Drive
Austin, TX 78754
FAX 512 450-6060
kstraub@cedracorp.com