Senior Biologics Engineer I (Drug Substance)

For Current Gilead Employees and Contractors:Please log onto your Internal Career Site to apply for this job.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.Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.Job DescriptionAs a member of Global Biologics Manufacturing Sciences and Technology (MSAT), the Senior Biologics Engineer I (Drug Substance) role is focused on technology transfer and support of commercial antibody and bioconjugate processes. We are seeking motivated, team-oriented individuals with expertise in biopharmaceutical drug substance processing.  The individual will serve as a key subject matter expert (conjugation/purification) for manufacturing and technology transfer activities including facility fit analysis, process validation, and post-approval changes.  They will serve as a functional representative working with internal and external manufacturing sites to establish commercial manufacturing processes for Gilead products, implement continued process verification, and provide ongoing support to ensure uninterrupted market supply. Job ResponsibilitiesRepresent Global Biologics MSAT on project teams as a subject matter expert for conjugation and purification manufacturing processes.Contribute to project workstreams such as facility fit, risk assessments, control strategy development, validation strategy, change management.  Author reports associated with these activities.Collaborate with process development group to support process characterization activities to enable commercial tech transfer and validation.  Participate in internal development teams as MSAT representative.Review technical documentation including protocols, master batch records, and reports for engineering runs, GMP and PPQ campaigns.Contribute to process validation sections of regulatory filings in support of commercial launch/expansion.Execute change management procedures to ensure timely and successful implementation of new processes and subsequent changes.  Partner with manufacturing, quality, and regulatory affairs during investigations to address OOS, OOT, and complex deviations.Participate in cross functional business and scientific initiatives as MSAT representative, and effectively collaborate and influence cross-functional partners to support team objectivesUp to 20% travel in support of the above activitiesQualificationsDegree in Chemical Engineering, Bioengineering, pharmaceutical sciences or related field, and appropriate years of experience: Ph.D. with 0+ years work experience OR MS with 4+ years of relevant work experience OR BS with 6+ years of relevant work experienceStrong understanding of biologics drug substance downstream manufacturing processes i.e., conjugation, purification operations, bulk freeze/thaw.Experience supporting drug substance manufacturing operations, technology transfer, and/or development.  Past history with commercial manufacturing and/or process validation is highly desirable.Working knowledge of GMP and regulatory requirements of biopharmaceutical manufacturingGeneral understanding of protein structure and modes of degradation under various processing conditionsExcellent troubleshooting skills and ability to solve complex technical issues.Ability to effectively collaborate in a dynamic, cross-functional matrix environment.Excellent and effective verbal and written communication skillsExperience working in agile global and multi-cultural teamsThe salary range for this position is: $133,280.00 - $172,480.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.For additional benefits information, visit: * Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.For jobs in the United States: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 or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACTYOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACTPAY TRANSPARENCY NONDISCRIMINATION PROVISIONOur environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.For Current Gilead Employees and Contractors:Please log onto your Internal Career Site to apply for this job.SummaryLocation: United States - California - Foster CityType: Full time