Senior Research Scientist I (Associate Director Level); Downstream Process Development, Oceanside CA

Location
Foster City
Salary
See job description.
Posted
October 20 2020
Ref
R0013657
Position Type
Full Time
Organization Type
All Industry


Senior Research Scientist I (Associate Director Level); Downstream Process Development, Oceanside CA
United States - California - Oceanside

Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

Making an impact on a global scale
Inclusion is one of the companys five core values. Thats because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible


Senior Research Scientist I (Associate Director Level); Downstream Process Development, Oceanside CA

Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.

Gilead has an opportunity for an experienced candidate in our Biologics Development group at our Oceanside facility in Southern California. We are seeking motivated, team-oriented individuals with scientific expertise in Downstream Process Development as well as clinical and commercial operations related to recombinant proteins. You will have the opportunity to work in teams for the early and late stage development of our protein molecules.

Specific Responsibilities:
  • Lead delegated activities for phase-appropriate downstream process development and technology transfer activities for monoclonal antibody, recombinant protein, and novel platform programs
  • Set strategy for process scale-up, FMEAs, process robustness and characterization studies, process validation, and regulatory filings
  • Review GMP and non-GMP technical documentation (batch records, SOPs, validation protocols & reports; process characterization protocols and reports)
  • Support investigations and identify root causes for critical deviations
  • Support internal and external manufacturing including Person-In-Plant (PIP) support
  • Participate on and lead cross-functional CMC teams
  • Demonstrate hands-on technical leadership in the laboratory, oversee and delegate experimental/project responsibilities as needed, and write/review development summary reports and author sections of regulatory submissions.
  • Be an effective communicator of ideas, project goals and results to team members across functional roles/departments. Proactively identify issues and develop solutions in a collaborative multidisciplinary environment.
  • Be self-motivated and organized, familiar with the relevant literature, and enjoy scientific investigation and thinking.
  • Lead, motivate, and develop team members.
  • Routinely make decisions affecting direction of project to ensure project timelines are met.


Knowledge, Experience and Skills:
  • PhD in a relevant scientific discipline with 3 years of industry experience.
  • BS or MS degree with extensive industry experience.
  • Expertise in mAb purification process development, characterization and validation.
  • Hands-on experience in downstream techniques such as centrifuge, chromatography, UF/DF and filtration.
  • Direct knowledge of product and process related impurity control in downstream process.
  • Experience in technical transfer to cGMP manufacturing for clinical and/or commercial products.
  • Experience in drafting CMC relevant sections of regulatory filings.
  • Strong, open and transparent communication skills (verbal and written).
  • Supervisory experience is preferred.

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 careers@gilead.com for assistance.

For more information about equal employment opportunity protections, please view the EEO is the Law' 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.


To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/United-States---California---Oceanside/Senior-Research-Scientist-I--Downstream-Process-Development--Oceanside-CA_R0013657-1





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