Senior Scientist -- Pre-Pivotal Biologics Analytical Operations
Senior Scientist -- Pre-Pivotal Biologics Analytical Operations
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$ 169320 - 219120
1 Vacancy
Job Description
At Gilead were creating a healthier world for all people. For more than 35 years weve tackled diseases such as HIV viral hepatitis COVID19 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 worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.
Every member of Gileads team plays a critical role in the discovery and development of lifechanging scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions and were 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
Gilead Sciences is seeking a talented and highly motivated Senior Scientist to join our PrePivotal Biologics Analytical Operations group. Our collaborative and interdisciplinary development team utilizes stateoftheart technologies and innovative methodologies to advance medicines into the clinic. The successful candidate is expected to serve as the CMC analytical lead on PDM (Pharmaceutical Development & Manufacturing) project teams. S/he will have opportunities for career growth through acquisition of new skills experiences and professional relationships in a fastpaced and resourcerich environment. This role will sit in our Foster City CA headquarters.
Responsibilities:
Lead CMC Analytical subteam (as ASTL) to identify molecule CQAs design/justify/execute endtoend control strategies support CMC process development issue CoTs seek Specfication endorsement and author relevant regulatory filings (Phase I/II IND/IMPD) for biologic drug substance and drug product.
Lead analytical characterization activities for prepivotal (Phase I/II) biologic molecules.
Develop and execute analytical methods (using HPLC CE iCIEF LCMS etc. to be used for molecule characterization and/or release testing. Author associated method development reports test procedures qualification 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 filings.
Basic Qualifications:
Bachelors Degree and Eight Years Experience
OR
Masters Degree and Six Years Experience
OR
Ph.D.
Preferred Qualifications:
Ph.D. in Analytical Chemistry Biochemistry Chemical Engineering Pharmaceutical Science or related fields with a minimum of 2 years of Biologics CMC industrial experience OR M.S. with a minimum of 6 years OR B.S. with a minimum of 8 years industrial experience in Biologics CMC.
Previous experience as Biologics CMC Analytical Lead is required.
Extensive handson experience on Biologics (especially mAbs) CMC Analytical Development/Operations and IND/IMPD Submissions
Strong Understanding of FDA and ICH guidelines relating to registration quality and compliance concerning drug substance and drug product.
Experience with analytical method development validation and control strategies of biologic products
Strong communication skills written oral etc.
Demonstrated ability of building strong collaborations with other CMC functions.
Familiar with lab automation data science and knowledge management is a plus.
Create Inclusion knowing the business value of diverse teams modelling inclusion and embedding the value of diversity in the way they manage their teams.
People Leader Accountabilities:
Create Inclusion knowing the business value of diverse teams modeling 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. They ensure employees are receiving the feedback and insight needed to grow develop and realize their purpose.
Empower Teams connect the team to the organization by aligning goals purpose and organizational objectives and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.
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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 disabilitygenetic information or characteristic gender identity and expression veteran status or other nonjob 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 theKnow 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 apply via the Internal Career Opportunities portal in Workday.
Required Experience:
Senior IC
Employment Type
Full-Time
