Senior Biologics Engineer I

Senior Biologics Engineer I
United States - California - Oceanside

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. Gilead’s 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 company’s five core values. That’s 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

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

At Gilead we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower teams to align and achieve goals.
Job Description


The Senior Biologics Engineer I (Drug Substance) role is focused on commercial technology transfer. We are seeking motivated, team-oriented individuals with expertise in biopharmaceutical drug substance processing. The individual will serve as a subject matter expert (upstream or downstream) for technology transfer activities including facility fit & gap assessments, capital improvements, risk assessments, and process validation. They will also serve as a key functional representative working with Contract Manufacturing Organizations to establish commercial manufacturing processes for Gilead products, implementing continuous process verification, and providing technical support during quality investigations and pre-approval inspections.

*Up to 20% travel is expected*

Job Responsibilities

• Represent Commercial Biologics Technical Operations on project teams in support of technology transfer and validation of biologics drug substance 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.
• Follow GMP quality change management procedures to ensure timely and successful technology transfer activities. Partner with process development, quality, and regulatory affairs during investigations to address OOS, OOT, and complex deviations.
• Collaborate with process development group to support process characterization activities and establishment of design space to support commercial tech transfer and validation. Participate in internal development teams as Commercial Technical Operations 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. Work with third party sites to ensure regulatory inspection readiness.
• Participate in cross functional business and scientific initiatives as CBTO representative, and effectively collaborate and influence cross-functional partners to support team objectives.
• Up to 20% travel in support of the above activities

Qualifications

• Degree in Chemical Engineering, Bioengineering, pharmaceutical sciences or related field, and appropriate years of experience: Ph.D. with no work experience OR MS with 4+ years of relevant work experience OR BS with 6+ years of relevant work experience
• Strong understanding of biologics drug substance manufacturing processes e.g., mammalian cell culture in bioreactors, harvest/recovery, downstream purification operations
• 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 GMPs and regulatory requirements of biopharmaceutical manufacturing
• Excellent troubleshooting skills and ability to solve complex technical issues.
• General understanding of protein structure and 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
• Experience of working in global and agile cultural teams

The salary range for this position is: $117,725.00 - $152,350.00. 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:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

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

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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 careers@gilead.com for assistance.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.

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Our 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.








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