Sr. Scientist, Biologics Process Characterization & Process Validation

Location
San Francisco, CA, United States
Posted
Oct 10, 2018
Ref
3383-394-2018
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time
Position Overview

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

POSITION SUMMARY:

The Senior Scientist will enable the successful drug substance process characterization, validation and manufacturing for an important oncology therapeutic. He/she will work closely with internal and external partners to ensure the development and execution of the process characterization plan, that enables a comprehensive master validation plan, and subsequent execution of process performance qualification (PPQ) runs at a contract manufacturing facility. Participation and technical leadership of the subject matter area is expected. Applies scientific principles and concepts to potential inventions, products and problems. This position plays a key role in launching one of the most exciting immuno-oncology programs in the industry.

RESPONSIBILITIES:

The Senior Scientist is responsible to ensure that the manufacturing process, facilities, equipment, raw materials and cleaning methods are validated and maintained in accordance with all Health Authority regulations and emerging trends in the industry. This person will develop:
  • Process characterization and validation plans
  • Process characterization and validation reports
  • Project plans, working with the project manager for this project
  • They will develop, review and approve necessary documentation, including requirements specifications, risk assessments, validation plans and the required installation, operational and performance qualifications, using defined procedures
  • They will proactively conceptualize, establish and lead the execution of the validation strategy for the organization. They will use their engineering or scientific background to understand the technical aspects of process validation in order to create strategies to enhance, optimize and improve Quality systems consistent with operational and compliance needs
  • They will monitor and report to management with project updates
  • Play a key role in problem solving related to manufacturing related technical challenges and implement long term changes that provide process and/or product improvements
  • Build and maintain successful cross-functional relationships with internal and external customers. Examples of partner organizations include Quality Assurance, Process Development, Regulatory and Analytical/QC
  • Prepares sections of NDA submissions when required
REQUIREMENTS:
  • A minimum of a Bachelor's Degree in a scientific or engineering discipline is required. Advanced degree e.g. Ph.D. is highly preferred
  • A minimum of 6 years of experience in the pharmaceutical industry is required
  • A thorough understanding of biologics drug substance process development, characterization and validation of processes at manufacturing sites is needed
  • Experience with late stage regulatory filings is highly preferred
  • Ability to translate vision and strategy into fine-tuned execution plans
  • Ability to work effectively across cross-functional teams and external partner organizations
  • Excellent written and oral communication skills
  • Ability to accommodate 20-30% travel
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.