Sr. Scientist, Biologics Fermentation/Cell Culture

Location
San Francisco, CA, United States
Posted
Aug 05, 2019
Ref
3623-394-2019
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time
Position Overview

The Sr. Scientist, Biologics Fermentation/Cell Culture will be responsible for participating and occasionally leading technical oversight of fermentation and/or mammalian cell culture processes executed at manufacturing sites.

Has responsibility over scaleup and characterization of the microbial fermentation, mammalian cell culture and primary recovery process. Engages strongly in attribute criticality assessment for fermentation/cell culture and primary recovery processes and impact on subsequent downstream processes. Participates and occasionally responsible for technology transfer to CRO/CMO and oversees 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 manufacturing development efforts to create high value therapeutics to address unmet medical needs.

Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. May determine methods and procedures on new assignments.

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 lead staff or a group, 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 5 years work experience in a biotechnology/pharmaceutical industry, preferably in areas of process development, technology transfer and/or manufacturing technical oversight is required. 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 is 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.

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.