Senior Biologics Engineer I, MS&T (Upstream)

Job Description

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 Description

Senior Biologics Engineer I, MS&T (Upstream)

Foster City, California

Gilead 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 team
• Participate 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 preferred
• Experience 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 desirable
• General 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 desirable
• High 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*.

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* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

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