Lead Biologics Engineer II

2 weeks ago

Foster City, California, United States Gilead Sciences, Inc. Full time
Senior Biologics Engineer II

Location: United States - California - Foster City

Employment Type: Full time

Job Overview

At Gilead, we are dedicated to creating a healthier world for everyone. For over 35 years, we have addressed critical health issues such as HIV, viral hepatitis, COVID-19, and cancer. Our relentless pursuit of developing therapies that enhance lives and ensure global access to these treatments drives our mission. We believe in the power of collaboration, determination, and a steadfast commitment to making a difference. Our leaders are encouraged to share ideas, listen, learn, and lead in an inclusive environment that fosters growth and innovation. Every member of Gilead's team plays a vital role in the discovery and development of transformative scientific advancements.

Position Summary

The Senior Biologics Engineer II (Drug Substance) position is centered on providing technical oversight for commercial manufacturing. We are looking for driven, team-oriented professionals with a strong background in biopharmaceutical drug substance processing. This individual will act as a key subject matter expert (downstream) for overseeing commercial manufacturing, process monitoring, capital enhancements, risk evaluations, and process validation as necessary. They will also represent the functional area while collaborating with Contract Manufacturing Organizations to establish commercial manufacturing processes for Gilead products, implement continuous process verification, and offer technical guidance during quality investigations and pre-approval inspections.

Key Responsibilities

  • Serve as a representative of Manufacturing, Science and Technology (MSAT) on project core teams and sub-teams, coordinating multi-functional activities to support the commercial manufacture of drug substance.
  • Work closely with the Process Development team to promote continuous improvement initiatives.
  • Review and endorse technical documentation, including protocols, master batch records, deviation records, and reports for commercial campaigns.
  • Draft manufacturing sections of regulatory submissions to support the lifecycle management of commercial products.
  • Implement business and quality change management procedures to ensure timely and effective continuous improvements and corrective actions.
  • Engage in cross-functional business and scientific initiatives as the MSAT representative.

Qualifications

  • A degree in Chemical Engineering, Bioengineering, Pharmaceutical Sciences, or a related field, with relevant experience:
    • Ph.D. with no years of relevant work experience OR
    • MS with 6+ years of relevant work experience OR
    • BS with 8+ years of relevant work experience
  • In-depth understanding of biologics drug substance manufacturing processes, particularly downstream purification operations.
  • Experience in supporting drug substance manufacturing operations, technology transfer, and/or development.
  • Familiarity with GMP and regulatory standards in biopharmaceutical manufacturing.
  • Strong troubleshooting abilities and a knack for resolving complex technical challenges.
  • General knowledge of protein structure and degradation mechanisms under various processing conditions.
  • Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
  • Exceptional verbal and written communication skills.
  • Experience working within global and agile cultural teams.

Compensation

The salary range for this position is: $154,000 - $199,000. Gilead considers various factors when determining base compensation, including experience, qualifications, and geographic location.

As an equal opportunity employer, Gilead Sciences Inc. is committed to fostering a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics.

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