Sr. Scientist, Biologics Purification

Location
San Francisco, CA, United States
Posted
Aug 05, 2019
Ref
3553-394-R
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time
Position Overview

The Biologics Purification & Manufacturing team is looking to hire a Sr. Scientist, Biologics Purification.

The Biologics Purification Development and Manufacturing team is responsible for the process tech transfer of downstream processing methodologies to cGMP manufacturing, and technical oversight of purification steps during batch production. Additionally, the Sr. Scientist supports other groups including upstream, analytical, and formulation development teams.

The candidate hired for this position will intimately familiar with unit operations in downstream process development, including harvest, chromatography, filtration, homogenization, and refold. Depending on the project need and candidate competencies, the candidate might also assist with 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
  • Purification process Scaleup and technology transfer to manufacturing sites
  • Oversight of biologics purification operations in manufacturing facilities, including Homogenization, centrifugation and/or filtration of cells, inclusion bodies, Protein Refold processes, various types of chromatography and Tangential flow filtration
  • Engagement in analytical assessment of process purity and performance
  • Demonstrates purification design through consistency runs and robustness evaluation
  • When necessary, supports CRO/CMO manufacturing through process demonstration, person in plant (PIP) coverage, and troubleshoots manufacturing issues
  • Writes reports and protocols as appropriate
  • Interfaces with various departments, customers and partners
  • Works well 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:

Candidates should possess relevant education in the biological sciences, engineering, or a related field, with experience in the biotechnology/pharmaceutical industry. The minimum education and experience expected for the following titles include: Sr. Scientist I: PhD with >7 years, BS with > 12 years or MS with > 10 years

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
  • Late stage process development and manufacturing
  • Process Characterization, validation, or commercialization
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.