Senior Research Scientist II, Analytical Development Pre-Pivotal Biologics

For Current Gilead Employees and Contractors: Please log onto your Internal Career Site to apply for this job.
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Job Description The Senior Research Scientist II, Analytical Development Pre-Pivotal Biologics will be responsible for development of analytical methods and strategies for monitoring and control of potency and process related impurities including method development, qualification, and transfer for Gilead’s biologics entities during pre-pivotal phases of development (pre-clinical, phase I/II).
He/She will also be responsible for developing control strategies for biologic drug substance and drug product as well as analytical regulatory strategies to enable successful regulatory filings.
Responsibilities: Establish and maintain a state of the art analytical development laboratory that will allow for rapid process development support and development of control system and characterization methods to determine potency by ELISA, as well as process related impurities including host cell protein, host cell DNA, affinity resin materials, etc.
Make decisions between establishing in-house technologies or testing via contract organizations.
Oversee data generation / data integrity and ensure compliance and analytical excellence from internal and outsourced testing at contract organizations.
Lead characterization, analytical control, and regulatory strategies for biologic drug substance and drug product.
Author associated test procedures, protocols, reports, and regulatory filings.
Lead analytical method development, validation, and transfer activities in support of PDM (Pharmaceutical Development & Manufacturing) project team needs.
Lead a team of analysts with a focus on analytical excellence as well as teamwork and collaboration across all PDM organizations.
Provide leadership and direction to members of his/her team within the Pre-Pivotal Analytical Development and QC Operations organization.
Support regulatory filings by authoring/reviewing CMC regulatory sections of IND/INDa; support associated agency interactions and product-related inspections.
Evaluate and implement state of the art technologies to drive innovation in Analytical Development and testing.
Serve as, and/or coach employees as, analytical lead for PDM pre-pivotal biologics programs to ensure successful IND/INDa applications.
Ensure strong relationships with key stakeholder functions including 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.
Qualifications: Ph.
D.
with 5+ years experience OR M.
S.
with 9+ years experience in Analytical Chemistry or related fields of industrial experience in biologics analytical development with people leader accountabilities.
Extensive experience with analytical method development, validation, and control strategies of biologic products.
Extensive experience with development and validation of ELISA based methods and well versed in separation (HPLC, CE, iCIEF) and/or mass spectrometric technologies/data interpretation.
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.
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 ApplicantAccommodations@gilead.
com for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
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For Current Gilead Employees and Contractors: Please log onto your Internal Career Site to apply for this job.