Scientist, Analytical Method Development and Characterization (Biologics)

Location
San Francisco, CA, United States
Posted
Sep 04, 2019
Ref
3476-396-2019
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time
Position Overview

The Scientist, Biologics Analytical Development will be responsible for product characterization, analytical method development/validation of proteins/protein-conjugates for Nektar's Biologic products in pre-clinical and clinical development stages.

Conducts and collaborates with others on analytical issues relevant to long-term objectives and concerns. Develops testing methodologies to support process development of drug substance and drug product.

The successful candidate will be responsible for:

• Characterize protein polymer conjugates to elucidate conjugate sites and distribution

• Develop and validate analytical methods to support late stage drug development activities

• Assist process development scientists to characterize and monitor in-process purification

• Transfer analytical methods to internal QC group or CRO for drug substance and drug product release testing

• Summarize experimental data and write technical reports

This position contributes to and supports the company's research development and manufacturing to create high value therapeutics to address unmet medical needs.

Responsibilities:

• Use professional concepts and company's policies and procedures to solve a wide range of difficult problems in imaginative and practical ways

• May determine methods and procedures on new assignments and recommend new methods and procedures

• May provide guidance to other lower level personnel

• Communicate cross-functionally with groups such as research, process development, formulation development, manufacturing, QC group and CRO/CMO to ensure appropriate project support

• Maintain a current knowledge of latest technological/scientific trends

Requirements: Requires a PhD in a scientific discipline and a minimum of 2+ years related experience, may include post-doctoral experience. Exceptional non-PhDs with demonstrated capabilities and/or significant experience may also be considered.

• Must have in-depth knowledge and hands-on experience in analytical method development and characterization for biologics

• Must be able to demonstrate potential for technical proficiency, scientific creativity, collaboration with others and independent thought

• Must be able to clearly communicate scientific information both written and oral.

• Must have experience in HPLC separation methods such as ion exchange, reversed phase, and size exclusion chromatography, and capillary electrophoresis for proteins is highly desirable

• Works on problems of moderate scope in which analysis of situation or data requires a review of identifiable factors

• Experience in technology transfer to internal QC lab or CRO in support of drug substance/drug product release testing is highly desirable

• Good computer skills are required. Working knowledge of MS word, Excel, Power point is a plus

• Must be willing to work as part of a team

Requires a PhD in a scientific discipline and a minimum of 2+ years related experience, may include post-doctoral experience. Exceptional non-PhDs with demonstrated capabilities and/or significant experience may also be considered.

• Must have extensive experience in mass spectrometry analysis of proteins

• Must have in-depth knowledge and hands-on experience in analytical method development and characterization for biologics

• Must be able to demonstrate potential for technical proficiency, scientific creativity, collaboration with others and independent thought

• Must be able to clearly communicate scientific information both written and oral.

• Experience in HPLC separation methods such as ion exchange, reversed phase, and size exclusion chromatography, and capillary electrophoresis for proteins is highly desirable

• Works on problems of moderate scope in which analysis of situation or data requires a review of identifiable factors

• Experience in technology transfer to internal QC lab or CRO in support of drug substance/drug product release testing is highly desirable

• Good computer skills are required. Working knowledge of MS word, Excel, Power point is a plus

• Must be willing to work as part of a team

Employees may be required to perform tasks essential to the job function in areas that require the use of hearing protection devices. Performance of tasks essential to the job function may require the employee to work directly with, handle, or otherwise come into contact with chemicals or pharmaceutical agents. Employees must be able to wear a respiratory protection (filtering facepiece, 1/2 face, full-face, or powered air purifying respirator, supplied air, or self contained breathing apparatus) for certain tasks essential to the job function. Employees may be required to enroll in a medical surveillance program based on the potential exposure to certain health hazards encountered as a result of their job function. Employees must be able to maneuver themselves under 30 inch clearances. Employees must be able to able to accurately detect color and have 20/20 vision (with/without corrective lenses).

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.