Research Scientist - Foster City, United States - Gilead Sciences

Gilead Sciences

Verified Company

Foster City, United States

3 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

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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.

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:

Responsibilities:

Lead analytical characterization activities for prepivotal (Phase I/II) biologic molecules. Identify molecule critical quality attributes, propose and justify analytical control strategies, author relevant regulatory filings for biologic drug substance and drug product.
Develop analytical methods to be used for molecule characterization and/or release testing. Author associated method development reports, test procedures, validation protocols and reports.
Oversee and advise data generation / data integrity and ensure compliance and analytical excellence from internal and outsourced testing at contract organizations.
Proactively evaluate and implement state of the art technologies to drive innovation in Analytical Development and testing.
Maintain strong relationships with key stakeholder functions and work crossfunctionally with colleagues in Research, Clinical Development, and Clinical Supply Management and Program Strategy Teams by providing technical and strategic input.
Provide technical support to internal and external cGMP manufacturing operations.
Presents research findings and recommendations to senior staff, prepare research reports and peerreviewed manuscripts, and contribute to the preparation of INDs, and patent filingsQualifications:
Ph.

D. in a relevant scientific discipline OR M.S. with 6+ years OR B.S. and 8+ years experience in Analytical Chemistry or related fields of industrial experience in biologics analytical development. Experience with analytical method development, validation, and control strategies of biologic products (e.g. HPLC, CE-SDS. iCIEF, LC-MS/MS, intact mass, gel electrophoresis, etc). Familiar with FDA and ICH guidelines relating to registration, quality, and compliance concerning drug substance and drug product. Ability of building strong collaborations with other CMC functions. Working knowledge of lab automation, computer validation, data governance, data science, knowledge management and data protection. Create Inclusion - knowing the business value of diverse teams, modelling inclusion and embedding the value of diversity in the way they manage their teams.
Gilead Core Values- Integrity (Doing What's Right) Inclusion (Encouraging Diversity) Teamwork (Working Together) Excellence (Being Your Best) Accountability (Taking Personal Responsibility)

The salary range for this position is:
$154, $199, 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*.

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