Sr. Scientist, Biologics (Downstream)

Position Overview

Leads in the execution of product development activities for the company and participates in planning and strategy.

We are currently seeking a Sr. Scientist, Biologics (Downstream) resident in our San Francisco Mission Bay office. The Sr. Scientist applies scientific principles and concepts to potential inventions, products and problems; leads in the planning and execution of laboratory research/experimentation; and maintains broad knowledge of state-of-the-art principles and theories. This individual is responsible for the upstream process development (fermentation and cell culture). Additionally, s/he manages Nektar internal CMC development efforts as well as technology transfer and manufacturing activities at contract manufacturing organizations (CMOs); directs the CMC development and clinical manufacturing activities at CMOs and collaborations with external partners for biologic products; manages the development, process characterization and tech-transfer of early to late stage biologics; and acts as a liaison with research to ensure processes and designs are compatible. This job contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs.

Additional responsibilities:

• 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.
• Develops tasks and maintain timelines to support development of manufacturing technology processes.
• Manages project workloads to provide innovative technical solutions to meet project deadlines.
• Supports and maintains development report writing systems, development reports, documents and data storage.
• Prepares sections of NDA submissions when required.
• Ensures budgets, schedules and performance requirements are met.
• Helps to ensure the effective application of process technologies across partner projects.
• Assists technical project leaders, scientist and process engineers in preparing and updating project work plans.
• Facilitates technology transfer between organizations and sites to meet required project goals.
• Quality compliance for pharmaceutical products and/or bulk pharmaceutical raw materials/intermediates.
• May act as spokesperson on corporate research/technology/development and advise senior management.
• Synthesizes multiple data sources and draws general, non-obvious conclusions.
• Defines complex problems, develops approaches and develops experiments with sound judgment.
• Leads in the development of patent applications.
• Interfaces with various departments, customers and partners.
• Puts work practices in context with larger team and participates in the implementation of change when required.
• Plans and coordinates activities with other team members.
• Writes and/or approves complex reports and protocols. Identifies needs for additional resources.
• May assist with designing and implementing organizational processes, budgetary and capital equipment requirements, and identifies needs for additional resources.
• May lead staff or a group, provides training as needed, and ensures adherence to company policies and quality requirements.

Requirements:

A PhD in a related scientific discipline is required. Equivalent experience may be accepted. A minimum of 5 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. A minimum of 4 years previous biotechnology/pharmaceutical industry experience, preferably in a process development FDA regulated environment, is required.

• Must have experience within R&D and/or biologics CMC that includes pilot plant, scale up and commercial manufacturing.
• Must have experience in technology transfer from development into a pharmaceutical production operation.
• 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 cGMPs as they apply to laboratory practices are highly desired.
• Previous management skills are a plus.
• Project management experience is a plus.
• A proven ability to work within a budget and timeline and provide cost savings is required.
• 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.