Gilead Sciences is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.For Current Gilead Employees and Contractors:Please log onto your Internal Career Site to apply for this job.Job DescriptionSr. Biologics Engineer III, MS&T - Drug ProductGilead 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.This position is responsible for providing technical expertise and leadership to drive the seamless technology transfer and process validation activities for biological drug product manufacturing processes. The incumbent will engage and work with both internal (product/process development teams) and external partners (CMOs) to ensure all the drug product processes are robust, scalable and well characterized before introducing into clinical or commercial manufacturing facilities. The individual will lead in the design and execution of validation strategies, qualifying new fill lines and sites to ensure supply plan meets the regional demand forecast and MOH targets. The individual will also serve as a key process owner in leading CMOs on establishing GMP processes, continuous process verifications, driving process improvements and providing technical leadership during quality investigations of complex deviations/non-conformances. The incumbent is expected to work closely with regulatory in preparation/coauthoring regulatory filings (CTAs, BLAs, CBE and PAS) and addressing issues associated with CMC actionable complaintsThis position requires an individual with proven track record of achievement in managing complex manufacturing execution systems, excellent/effective communication and people skills.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.Participate in cross functional business and scientific initiatives as the MS&T representative, and effectively collaborate and influence cross-functional partners to support MS&T objectives.Lead 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.Lead the process validation activities ensuring design of validation strategy is in alignment with business needs, regional & global regulatory compliance and support continued process verification post validation.Review and approve technical documentation including protocols, master batch records, and reports related to engineering run, GMP run and PPQ runs.Ensure regulatory inspection readiness and product compliance with regional regulatory requirements.Partnering with product development, manufacturing, quality and regulatory, lead 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.Develop and implement control strategy, identify and implement operational improvements and identify novel technological approaches to improve product quality attributes and enhance yield.Knowledge, Experience & Skills: Preferred degree in Chemical Engineering, Bioengineering, Pharmaceutical Sciences or related field.Experience in managing complex manufacturing execution systems including tech transfer, process characterization, process validation of biological products is highly desirable.Process development and operations experience/expertise in drug product manufacturing processes including bulk freeze/thaw, mixing/pooling, filtration, filling and lyophilization.General understanding of protein structure and its 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.Basic Qualifications:PhD; or Master's degree and 8 + years of relevant experience; or Bachelor's degree and 10+ years of relevant experience.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 email@example.com for assistance.Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S. employees and contractors to receive the COVID-19 vaccines as a condition of employment. "Full vaccination" is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.For more information about equal employment opportunity protections, please view the 'EEO is the Law' 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.