Scientist, Analytical Development

Location
Huntsville, AL, United States
Posted
Sep 06, 2018
Ref
3165-395-2017
Required Education
Masters Degree/MBA
Position Type
Full time
Position Overview

This laboratory leadership position provides direction to conduct a broad spectrum of analytical activities.

The selected candidate will independently apply scientific and cross-functional knowledge to achieve project goals by designing, executing, interpreting complex experiments and generating comprehensive reports. Candidates should have experience in the development/ implementation of new/rugged analytical methods using state-of-the-art analytical technologies. A broad knowledge of analytical techniques such as HPLC, GC, LC-MS, NMR, GC-MS, SDS-PAGE, CE, isolation/purification of impurities/degradants using standard/specialized analytical systems and excellent oral/written communication skills is a plus. The individual will have to evaluate and interpret complex data and test results (e.g., stability studies, GC/MS, LC/MS/MS studies). To qualify, you must have a Ph.D. in Chemistry or in Pharmaceutical Sciences preferably with a core expertise/experience in Analytical Chemistry/Separation Sciences/Instrument Analysis area with 2 years (or greater) of relevant Laboratory experience in the pharmaceutical or biopharmaceutical industry. Experience with protein analysis is a plus.

This laboratory leadership position provides direction to conduct a broad spectrum of analytical activities such as development and validation of new analytical methods for development products (pre-clinical through commercialization) for in-process, release and stability analysis, as well as transfer the methods to Contract Manufacturing organizations (CMOs). The position includes the responsibility to monitor/evaluate completion of project related tasks, generate all CMC documents to support US/EU health authority submissions, modify/propose new specifications, write/coordinate regulatory updates/filing activities for new methods/ specifications, and work closely with CMO laboratories to evaluate /test analytical methods for development products. The position supports all laboratory activities to comply with cGMP requirements, maintenance of project-related reference standards/reference materials, and train/mentor laboratory staff on new analytical technology which would enhance problem solving capability, technical expertise and throughput. The position has the opportunity to make major contributions to scientific literature, conferences and/or understanding of company processes. This position contributes to and supports the company's pipeline development efforts to create high value therapeutics to address unmet medical needs.

A PhD in a scientific discipline is required. Equivalent experience may be accepted. A minimum of 2 years work experience in a research and/or development environment is required. Post-doctoral work may serve as experience. Exceptional non-PhDs with demonstrated capabilities and/or significant experience may also be considered. Must be able to demonstrate significant success in technical proficiency, scientific creativity, collaboration with others and independent thought. Must be current and active in field, while able to demonstrate expert knowledge in scientific principles and concepts both internally and externally with sustained performance and accomplishment. Must be able to clearly communicate scientific information both written and oral. Must be able to compose sound written work. Must possess good oral and written communication skills. Ability to present technical information to both technical and non-technical audiences is required. Must be able to demonstrate sound judgment. Must be able to demonstrate problem solving capabilities. Strong organizational skills are required. Good computer skills are required. Working knowledge of MS word, Excel, Power point is a plus. Experience working in an FDA regulated environment and knowledge of current GMPs as they apply to laboratory practices are highly desired. Previous management skills are a plus. Must be willing to work as part of a team. Must be able to demonstrate good interpersonal skills.

We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.