- Lead cell culture process development and implementation in internal and external GMP facilities, as well as technical support of GMP operations.
- Establish and maintain a state-of-the-art cell culture process development laboratory.
- Lead cell culture process technology development and platform process evolution projects for increased productivity, high quality product, and speed to clinic.
- Design and conduct laboratory scale experiments; hands-on laboratory execution is expected.
- Review GMP and non-GMP technical documentation (batch records, SOPs, guidance documents, and reports).
- Ensure high-quality documentation in electronic laboratory notebooks and reports.
- Author relevant sections of regulatory filings and responses to information requests.
- Support investigations and identify root causes for critical deviations.
- Travel as required to support technology transfers and provide oversight at external manufacturing facilities.
- Contribute to business process improvements related to early-stage process development.
- Adhere to department budget and all training, compliance and safety requirements.
- Mentor junior team members on cell culture process development strategies and experimental design and execution.
- Participate on cross-functional initiatives.
- Ph.
- Hands-on laboratory operations experience including shake flask, high-throughput bioreactor, bench scale bioreactor, and pilot scale cultures.
- Experience in pre-pivotal stage cell culture process development and implementation in GMP facilities.
- Excellent communication, technical writing, and presentation skills and aptitude for creative problem solving.
- Demonstrated ability to collaborate and influence cross-functionally.
- Experience in statistics, design-of-experiments, and data analysis (e.g. JMP, Spotfire).
- Working knowledge of lab automation, data management, data science, knowledge management and data protection.
- Passion for inclusion: knowing the business value of diverse teams, modelling inclusion, and embedding the value of diversity in the way he/she works.
- Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
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senior research scientist i, cell culture process development - Foster City, CA, United States - Gilead Sciences, Inc.
Description
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
Senior Research Scientist I, Cell Culture Process Development - Pre-Pivotal Biologics CMC Development - Foster City, CA
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
The Senior Research Scientist I, Cell Culture Process Development (Pre-Pivotal) will be responsible for leading aspects of cell culture development including process development and process implementation at internal or external GMP facilities for Gilead biologics entities during pre-pivotal phases development (pre-clinical, phase I/II).
Key Responsibilities:
Qualifications/Skills/Experience:
with 8+ years OR 10+ Years with BS experience in a relevant scientific discipline (biology, bioengineering, chemical engineering, biochemical engineering).
The salary range for this position is: $177, $230, Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location.
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:
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 for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.NOTICE:
EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
PAY TRANSPARENCY NONDISCRIMINATION PROVISION
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.
