Leading purification 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). He/she will also lead projects for purification process technology development, platform process evolution, and purification related regulatory documentation. This role is expected to work collaboratively with cross-functional stakeholders and contribute to the regulatory s... more details
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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.
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.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
Job Description
Senior Research Scientist II, Purification Development - Pre-Pivotal Biologics – 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 II, Purification Process Development (Pre-Pivotal) will be responsible for leading purification 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). He/she will also lead projects for purification process technology development, platform process evolution, and purification related regulatory documentation. This role is expected to work collaboratively with cross-functional stakeholders and contribute to the regulatory strategies and successful filings of Gilead’s biologics entities.
Key Responsibilities:
- Establish and maintain a state-of-the-art purification lab that enables rapid new biologics entity manufacturability assessment, purification process development and scaleup.
- Lead efficient purification process development. Design and conduct laboratory scale experiments and oversee data generation/data integrity to ensure compliance. Hands-on laboratory execution is expected.
- Transfer process to internal and contract manufacturing facilities to produce GMP and non GMP drug substances on time and with high success rate. Provide technical oversight at internal and external manufacturing facilities as person-in-plant. Lead manufacturing atypical event investigations.
- Review GMP and non-GMP technical documentation (batch records, SOPs, guidance documents, and reports).
- Author/review and/or coach team members to author CMC regulatory sections of IND/INDa. Contribute to regulatory strategies and support associated agency interactions and product-related inspections.
- Hire and develop scientists. Keep abreast of technology and innovation trends as well as best industry practices to establish a highly efficient purification team. Mentor team members on purification process development strategies, experimental design and execution as well as process transfer.
- Drive purification platform development and new technology/innovation evaluation and implementation to enable fast first-in-human clinical trial timeline. Contribute to workflow improvements for screening lead molecules with optimal developability.
- Collaborate with key stakeholder functions including Analytical Development, Cell Culture, Formulation Development, Research, Clinical Operation, and Program Strategy Teams by providing technical and strategic inputs.
- Contribute to strategies and long-range plans in line with Gilead strategic priorities to deliver on Gilead’s long-term ambitions.
- Participate in cross functional initiatives.
- Adhere to department budget and all training, compliance and safety requirements.
Qualifications:
- Ph.D. in chemical engineering, bioengeering, biochemical engineering, biochemistry or related field with 5+ years industrial experience in biologics purification development with people leader accountabilities. OR a MS and 9+ years of related experience OR BS and 11+years
- Demonstrated experience in process transfer to clinical manufacturing facility and technical leadership in process troubleshooting.
- Knowledge in single-use manufacturing technology and GMP guideline is a plus.
- Well versed in FDA, EMA and ICH guidelines relating to registration, quality, and compliance concerning drug substance and authored CMC sections in INDs.
- Working knowledge in lab automation, data science, and knowledge management is a plus.
- Leadership qualities of the successful candidate include the following: collaboration, building and developing high performing teams, accountability, cross functional engagement and influence. Ability to build high performing teams and to set clear and measurable goals for staff and prioritize projects and resources.
- Create Inclusion - knowing the business value of diverse teams, modelling inclusion and embedding the value of diversity in the way they manage their teams.
- Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. Ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
- Empower Team - connect the team to the organization by aligning goals, purpose, organizational objectives and holding to account. Provide the support needed to remove barriers and connect their team to the broader ecosystem.
The salary range for this position is: $191,335.00 - $247,610.00. 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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For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
