Senior Scientist Biologics Pre-Pivotal Formulation Process Development
Senior Scientist Biologics Pre-Pivotal Formulation Process Development
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$ 169320 - 219120
1 Vacancy
Job Description
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
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
TheSenior Scientist Biologics PrePivotal Formulation and Process Developmentrole is part of the collaborative and interdisciplinary CMC development team aiming to use stateofthe art technologies and innovative methodologies to advance medicines into the clinic.
The successful candidate is expected to bring relevant technical expertise contribute to key functional strategies and serve as drug product 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.
Responsibilities:
Design and execute formulation and drug product process development work packages including molecular assessment FirstinHuman formulation development Drug Product manufacturing process development and clinical inuse evaluations.
Demonstrate deep understanding of analytical biophysical characterization or process development techniques; bring new capabilities; lead by example for lab executions
Represent FPD function by managing one or more critical component of crossfunctional team and work collaboratively and effectively to advance project strategy and objectives
Manage one or more longterm critical components of a crossfunctional project with limited supervision.
Leads or contributes to initiatives or evaluation of new technologies in support of optimizing FPD work practices and/or achieving departmental goals.
Influence internal and external stakeholders through publications presentations and representation in industrial collaborations by driving innovation and continuously growing and sharing technical expertise.
Support initiative teams to drive business process excellence improve research and development procedures and advance scientific innovation.
Participate in the interviewing assessment onboarding and coaching new team members
Fully embrace data integrity and good documentation practices for data and report generation; critically review internal and external documentation.
Qualifications:
Ph.D. in Pharmaceutical Science Chemistry Biochemistry Chemical Engineering or related fields with a minimum of 2 years of industrial experience OR M.S. with a minimum of 6 years of industrial experience OR B.S. with a minimum of 8 years of industrial experience.
Experience should be in biologics CMC development.
Extensive experience with formulation development Drug Product process development and clinical inuse evaluation of monoclonal antibodies bispecifics antibodydrug conjugates fusion proteins and other complex biologics formats
Broad experience with earlystage development activities including authoring and submission of INDs and IMPDs.
Handson in lab and has experience of training junior members.
Publication and external presentation track records demonstrating strong technical innovation capabilities and industrial influence.
Experience and expertise in lyophilization cycle development development of viral vectors and vaccines GMP drug product fill and finish lab automation and data science are highly desired.
People leading experience is strongly desired.
Experience working with contract organizations is highly preferred.
Gilead Core Values
Integrity (Doing Whats Right)
Inclusion (Encouraging Diversity)
Teamwork (Working Together)
Excellence (Being Your Best)
Accountability (Taking PersonalResponsibility)
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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 log onto your Internal Career Site to apply for this job.
Required Experience:
Senior IC
Employment Type
Full-Time
