Senior Biologics Engineer I, MS&T (Upstream)

Company:  Gilead Sciences
Location: Foster City
Closing Date: 07/11/2024
Hours: Full Time
Type: Permanent
Job Requirements / Description

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 DescriptionSenior Biologics Engineer I, MS&T (Upstream)Foster City, CaliforniaGilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.Gilead has an opportunity for an experienced Senior Biologics Engineer I. We are seeking motivated, team-oriented individuals with expertise in biopharmaceutical processing.Job Responsibilities:Represent Manufacturing Sciences and Technology (MS&T) on project core teams and sub-teams as a Subject Matter Expert (SME) to coordinate multi-functional activities relating to clinical and commercial drug product manufacturing processes, tech transfer, validation, supply/supply chain, quality/ compliance, change management and product life cycle management.Apply real-time data analysis and work closely with CPV teamParticipate in cross functional business and scientific initiatives as a MS&T representative.Support technology transfer activities ensuring gap analysis/risks assessments are performed and mitigation plans are in place through internal/on-site characterization and engineering runs, ensure design spaces (PAR & NOR ranges) are built for critical process parameters for validation and routine manufacturing operations, effective information flow, issue resolution, and documentation in accordance with the expectations of tech transfer quality system.Support the process validation activities and support continued process verification post validation.Draft and/or review technical documentation including protocols, master batch records, and reports related to engineering runs, GMP runs and PPQ runs.Support regulatory inspection readiness and product compliance with regional regulatory requirements.Partnering with product development, manufacturing, quality and regulatory, support quality investigations and data analysis as SME to address OOS, OOT, complex deviations/non-conformances and implement change controls to ensure timely/prompt release of batches to meet regional demand forecast and ensure CAPAs are in place.Support implementation of operational improvements and novel technological approaches to improve product quality attributes and enhance yield.Knowledge, Experience & Skills:Strong organizational skills.Degree in Chemical Engineering, Bioengineering, Pharmaceutical Sciences or related field, preferred.Working knowledge of GMP and regulatory requirements of biopharmaceutical manufacturing is preferredExperience in tech transfer/scale-up, process characterization, process validation of biological products is highly desirable.Process development and/or operations experience/expertise in biopharmaceutical manufacturing processes highly desirableGeneral understanding of antibody manufacture and the critical/key inputs/outputs of operations.General understanding protein structure and its modes of degradation under various processing conditions.Excellent troubleshooting skills and ability to solve complex technical issues.Understanding of guidelines required by FDA, EMA, and other regulatory bodies.Strong interpersonal and communication skills, verbal and written.Ability to effectively collaborate in a dynamic, cross-functional matrix environment.Experience of working in agile cultural teams highly desirableHigh degree of technical competence and effective communication skills, both oral and written.Able to identify data or analytical issues and assist with providing solutions by either applying own skills and knowledge or seeking help from others.Able to build strong relationship with peers and cross-functional partners to achieve higher performance.Basic Qualifications:Master's degree and 4+ years of relevant experience; or Bachelor's degree and 6+ years of relevant experience.The 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: 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 for assistance.For more information about equal employment opportunity protections, please view the 'Know Your Rights' ( poster.NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT ( RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACTPAY TRANSPARENCY NONDISCRIMINATION PROVISION ( 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.Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

Apply Now
An error has occurred. This application may no longer respond until reloaded. Reload 🗙