Lead Biologics Engineer

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 enhancing global health. With over 35 years of experience, we have confronted significant diseases including HIV, viral hepatitis, COVID-19, and cancer. Our commitment to developing effective therapies is unwavering, and we strive to ensure that these treatments are accessible worldwide. Our mission is fueled by collaboration, determination, and an unyielding desire to make a positive impact. We encourage our leaders to share insights, listen, learn, and guide others. We are fostering a diverse and inclusive environment that promotes growth and innovation, where every team member contributes to groundbreaking scientific advancements.

Position Summary

The Senior Biologics Engineer II (Drug Substance) is primarily responsible for overseeing the technical aspects of commercial manufacturing. We are looking for proactive, team-oriented professionals with a strong background in biopharmaceutical drug substance processing. This role will involve serving as a principal subject matter expert (downstream) for commercial manufacturing oversight, process monitoring, capital enhancements, risk evaluations, and process validation as necessary. Additionally, the individual will act as a vital representative collaborating with Contract Manufacturing Organizations to establish commercial manufacturing protocols for Gilead products, implement ongoing process verification, and provide technical guidance during quality assessments and pre-approval inspections.

Key Responsibilities

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

Qualifications

  • Degree in Chemical Engineering, Bioengineering, Pharmaceutical Sciences, or a related field, with the following experience:
    • Ph.D. with no relevant work experience OR
    • Master's degree with 6+ years of relevant experience OR
    • Bachelor's degree with 8+ years of relevant experience
  • Comprehensive understanding of biologics drug substance manufacturing processes, particularly in 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 problem-solving skills and the ability to address 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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