Research Associate III

Position Overview

Responsible for the process development and subsequent tech transfer of downstream processing methodologies to cGMP Manufacturing.

Summary:

The Biologics Process Sciences purification team is responsible for the process development and subsequent tech transfer of downstream processing methodologies to cGMP Manufacturing. Additionally, the purification team supports other groups including upstream, analytical, and formulation development teams.

The candidate hired for this position will primarily perform a variety of laboratory procedures in downstream process development, including chromatography, filtration, homogenization, refold, and/or centrifugation experiments. Depending on the project need and candidate competencies, the candidate might also assist with technology transfer of processes to GLP and cGMP facilities or occasionally provide person-in-plant (PIP) support for critical manufacturing operations. The ideal candidate will demonstrate expertise in purification scale-up principles, competency in planning and executing hands-on experimentation, and the ability to work well within a team dynamic in a fast-paced work environment.

Responsibilities:

• Protein purification process development and lab-scale production
• Chromatography screening and optimization using AKTA systems
• Primary recovery including Homogenization, centrifugation and/or filtration of cells, inclusion bodies, or precipitates
• Protein Refold processes
• Tangential flow filtration
• Analytical assessment of process purity and performance
• Lab-scale purification runs to support analytical, research, and GLP needs
• Scale-up, tech transfer, and CMO manufacturing support
• Demonstrates purification design through consistency runs and robustness evaluation
• Tech transfers purification processes to CROs and CMOs
• When necessary, supports CRO/CMO manufacturing through process demonstration, person in plant (PIP) coverage, and troubleshoots manufacturing issues

General Duties:

• Writes reports and protocols
• Interfaces with various departments, customers and partners
• Works in a team environment
• Maintains documentation of experiments and/or batch records according to good documentation practices
• Manages daily lab operations including stocking consumables, lab organization and cleanliness, and safety
• Maintains project timelines
• Occasional international or domestic travel to partner and contract facilities as needed

Requirements:

A minimum of a Bachelor's degree in a scientific discipline is required. Equivalent experience may be accepted. A minimum of 8 years work experience in a research and/or development environment is required.

In addition, the following minimum skills, knowledge and abilities are required:

• Hands on experience in protein purification, including familiarity with process design and scale-up for the following operations: chromatography, tangential flow filtration, membrane filtration, depth filtration, protein refolding, homogenization, and centrifugation
• Experience with process analytics including HPLC, SDS-PAGE
• Experience with AKTA chromatography systems and software
• Must be able to demonstrate hands-on technical proficiency
• Able to independently conduct experiments and present work
• Ability to work in a fast-paced, goal-oriented environment
• Scientifically knowledgeable, team-orientated, and passionate in biopharmaceutical development
• Excellent written and oral communication skills
• Must possess a positive, can-do attitude and demonstrate creative, problem-solving skills
• Attention to details and excellent verbal/written communication skills
• Flexibility and ability to adapt to quickly changing priorities
• Ability to successfully operate while multi-tasking
• Demonstrated ability to effectively and collaboratively work in cross-functional teams, meet deadlines, and prioritize multiple activities

A strong preference for candidates with some or all of the following experience:

• Experimentation and scale-up of protein refolding, homogenization, and/or centrifugation
• Protein purification from E.coli or other bacterial fermentations
• Tech transfer from lab to clinical manufacturing
• Working in a GLP or GMP environment

Additional experience in any of the following is valued:

• Working knowledge of upstream processing/ microbial fermentation
• E. coli cell lysis and inclusion body processing

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.