Scientist, Biologics Fermentation/Cell Culture

Location
San Francisco, CA, United States
Posted
Oct 10, 2020
Ref
5167-394-2020
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time
Position Overview

Nektar has an exciting opportunity for a Scientist, Biologics Fermentation/Cell Culture to join their External Manufacturing Team.

Responsible for supporting the scale-up and tech-transfer of recombinant protein production processes including the development, optimization, and characterization of microbial fermentation, mammalian cell culture, and primary recovery processes. Designs and executes experiments to characterize manufacturing processes for the production of recombinant proteins. Performs primary recovery. Analyzes quality of expressed proteins using basic analytical techniques, i.e. SDS-PAGE, HPLC, etc. Participates in technology transfer to CRO/CMO and oversee process development, scale-up and/or GMP production activities at CMOs. Reviews and/or authors the CMC sections of regulatory filing documents. This position contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs.

Works on problems of diverse scope in which analysis of data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Normally receives no instructions on routine work, general instructions on new assignments. Synthesizes multiple data sources and draws general, non-obvious conclusions. Defines problems, develops approaches and develops experiments with sound judgment with minimal supervision. Uses professional concepts and scientific knowledge to contribute to the development of company concepts and principles to achieve objectives in creative and effective ways. Develops, optimizes and characterizes of the microbial fermentation, mammalian cell culture and primary recovery process. Designs and executes fermentation and mammalian cell culture process to express recombinant proteins. Performs primary recovery. Analyzes quality of expressed proteins using basic analytical techniques, i.e. SDS-PAGE, HPLC, etc. Performs day-to-day planning, execution and analysis of laboratory experiments independently with minimal supervisions. Defines complex problems, develops approaches and develops experiments with sound judgment. Interfaces with various departments and partners. Plans and coordinates activities with other team members. Writes and/or approves complex reports and protocols. Maintains knowledge of regulatory compliance requirements. May assist with implementing organizational systems, identifying capital equipment, and projecting resource requirements. May mentor or manage staff, provides training as needed, and ensures adherence to company policies and quality requirements.

A PhD in a scientific or engineering discipline is required. Equivalent experience may be accepted. A minimum of 2 years work experience in a biotechnology/pharmaceutical industry, preferably in a process development, 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. 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 required. Experience working in an FDA regulated environment and knowledge of current GMPs as they apply to laboratory practices are highly desired. Experience with regulatory filings is a plus. Previous management experience is a plus. Must be willing to work as part of a team. Must be able to demonstrate good interpersonal skills.

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.