Biologics Engineer III, MS&T (Upstream)
Biologics Engineer III, MS&T (Upstream)
United States - New Jersey - Morris Plains
Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
Making an impact on a global scale
Inclusion is one of the companys five core values. Thats because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.
When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible
Biologics Engineer III, MS&T (Upstream)
Morris Plains, New Jersey
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 Biologics Engineer III (Upstream) at our biologics facility in Morris Plains, New Jersey. We are seeking motivated, team-oriented individuals with expertise in upstream biopharmaceutical processing.
- 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 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 run, GMP run 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 upstream biopharmaceutical manufacturing processes including seed expansion operations, single-use and stainless-steel bioreactor operations, fed-batch/perfusion processes, harvest operations, basal media formulation, etc. highly desirable.
- General understanding of cell culture processing 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.
- Master\'s degree and 4+ years of relevant experience; or Bachelor\'s degree and 6+ years of relevant experience.
To apply, please submit resume through our website at www.gilead.com
Gilead is an equal opportunity employer.
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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 firstname.lastname@example.org 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.\u200b
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