Senior Biologics Engineer II

Foster City, CA, United States

Senior Biologics Engineer II page is loaded Senior Biologics Engineer II Bewerben locations United States - California - Foster City time type Full time posted on Vor mehr als 30 Tagen ausgeschrieben job requisition id R0039938 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.We empower our leaders to step up, share ideas, listen, learn, and lead. We’re welcoming bright, diverse, and imaginative minds; we’re nurturing them to foster an environment of inclusion and growth where innovation is encouraged. We expect our people leaders to model that environment, and to focus on creating inclusion, developing talent, and enabling teams.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. Join Gilead and help create possible, together.

Job Description 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.

The Senior Biologics Engineer II (Drug Substance) role is focused on commercial manufacture technical oversight. We are seeking motivated, team-oriented individuals with expertise in biopharmaceutical drug substance processing. The individual will serve as a key subject matter expert (downstream) for commercial manufacture oversight, process monitoring, capital improvements, risk assessments, and process validation where applicable. 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 leadership during quality investigations and pre-approval inspections.

Job Responsibilities

Represent Manufacturing, Science and Technology (MSAT) on project core teams and sub-teams as a Subject Matter Expert (SME) to coordinate multi-functional activities to support commercial manufacture of drug substance. Lead or contribute to project workstreams such as risk assessments, control strategy management, continuous improvement, and change management throughout the product lifecycle.

Collaborate with Process Development group to support continuous improvement initiatives. Participate in internal development teams as MSAT representative.

Review and approve technical documentation including protocols, master batch records, deviation records, and reports for commercial campaigns.

Author manufacture sections of regulatory filings in support of commercial product lifecycle management. Ensure regulatory inspection readiness and product compliance with regional regulatory requirements.

Implement business and quality change management procedures to ensure timely and successful continuous improvements/CAPAs.  Partner with product development, manufacturing, quality, and regulatory during investigations to address OOS, OOT, and complex deviations.

Participate in cross functional business and scientific initiatives as MSAT representative, and effectively collaborate and influence cross-functional partners to support team objectives

Qualifications

Degree in Chemical Engineering, Bioengineering, pharmaceutical sciences or related field, and appropriate years of experience: Ph.D with 0 years of relevant work experience OR

MS with 6+ years of relevant work experience OR

BS with 8+ years of relevant work experience

Strong understanding of biologics drug substance manufacturing processes with focus on 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 GMP 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: $154,020.00 - $199,320.00. 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.

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 protected]  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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About Us 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.

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