Senior Biologics Engineer II

Senior Biologics Engineer II

locations: United States - California - Foster City

time type: Full time

posted on: Vor mehr als 30 Tagen ausgeschrieben

job requisition id: R0039938

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. We empower our leaders to step up, share ideas, listen, learn, and lead. We’re welcoming bright, diverse, and imaginative minds; we’re nurturing them to foster an environment of inclusion and growth where innovation is encouraged. Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations.

Job Description

The Senior Biologics Engineer II (Drug Substance) role is focused on commercial manufacture technical oversight. We are seeking motivated, team-oriented individuals with expertise in biopharmaceutical drug substance processing. The individual will serve as a key subject matter expert (downstream) for commercial manufacture oversight, process monitoring, capital improvements, risk assessments, and process validation where applicable. They will also serve as a key functional representative working with Contract Manufacturing Organizations to establish commercial manufacturing processes for Gilead products, implementing continuous process verification, and providing technical leadership during quality investigations and pre-approval inspections.

Job Responsibilities

• Represent Manufacturing, Science and Technology (MSAT) on project core teams and sub-teams as a Subject Matter Expert (SME) to coordinate multi-functional activities to support commercial manufacture of drug substance.
• Collaborate with Process Development group to support continuous improvement initiatives.
• Review and approve technical documentation including protocols, master batch records, deviation records, and reports for commercial campaigns.
• Author manufacture sections of regulatory filings in support of commercial product lifecycle management.
• Implement business and quality change management procedures to ensure timely and successful continuous improvements/CAPAs.
• Participate in cross functional business and scientific initiatives as MSAT representative.

Qualifications

• Degree in Chemical Engineering, Bioengineering, pharmaceutical sciences or related field, and appropriate years of experience:
• Ph.D with 0 years of relevant work experience OR
• MS with 6+ years of relevant work experience OR
• BS with 8+ years of relevant work experience
• Strong understanding of biologics drug substance manufacturing processes with focus on downstream purification operations.
• Experience supporting drug substance manufacturing operations, technology transfer, and/or development.
• Working knowledge of GMP and regulatory requirements of biopharmaceutical manufacturing.
• Excellent troubleshooting skills and ability to solve complex technical issues.
• General understanding of protein structure and modes of degradation under various processing conditions.
• Ability to effectively collaborate in a dynamic, cross-functional matrix environment.
• Excellent and effective verbal and written communication skills.
• Experience of working in global and agile cultural teams.

The salary range for this position is: $154,020.00 - $199,320.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location.

As an equal opportunity employer, Gilead Sciences Inc. is committed to 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.