Sr. Scientist, Biologics (Bioassay)

Location
San Francisco, CA, United States
Posted
Jun 12, 2018
Ref
2-1-3206- 393-2018
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Position Summary:

A Sr. Scientist is responsible for bioassay method development, testing and management, as part of Nektar Biologics CMC organization to support Nektar biologics drug candidates in pre-clinical and clinical development. Knowledge and hands-on experience with development, qualification, and validation of cell-based bioassay for potency measurement to support GMP manufacture, product characterization, lot release, and stability testing are required. Experience in GMP, CRO management and quality is a must. Excellent written and verbal communication skills are required.

Responsibilities:

The successful candidate will be responsible for:
Establish and implement bioassay strategy to support Nektar biologics portfolio. Work on mechanism of action relevant bioassay to understand and characterize Nektar's biologics molecules. Participate efforts for in-house method qualification/ routine testing, and transfer methods to CRO for drug substance and drug product release and stability testing. Support technical project leaders and scientists in preparing and updating project work plans. Develop tasks and maintain timelines to support development of manufacturing technology processes. Communicate cross-functionally with groups such as research, process development, formulation development, manufacturing, QC group and CRO/CMO to ensure appropriate project support. Write technical reports of CMC section. This position contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs.

Requirements:

A minimum of a bachelor's degree in a biology/biochemistry discipline is required. Advanced degree such as PhD is preferred. A minimum of 5 years previous biotechnology/pharmaceutical industry experience, preferably in a process development of FDA and EMA regulated environment, is required.
A thorough knowledge and experience working in a GMP environment is essential. Prior experience with technology transfer and providing oversight to contract research organizations (CRO) is a must. Excellent written and verbal communications and team work skills are essential.
Prefer to have experience within R&D and/or biologics CMC that includes method development, stage appropriate validation, method transfer to CRO and routine sample testing for lot release and stability evaluation. Strong verbal and written communication skills are required. Must be goal-oriented, quality-conscientious, and customer-focused. Good compliance and safety practices are essential. Teamwork spirit is required. A thorough working knowledge of FDA, ISO and cGMP requirements for areas of responsibilities and project management experience is a plus.

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 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.

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.