Sr. Research Scientist II (Associate Director Level) Biologics Analytical Operations. Oceanside CA

Sr. Research Scientist II (Associate Director Level) Biologics Analytical Operations. Oceanside CA

 

Sr. Research Scientist II (Associate Director Level) Biologics Analytical Operations. Oceanside CA

 

Gilead Sciences is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.

 

Job Description

 

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.

 

We are seeking a Senior Research Scientist II, for our Analytical Operations team. Broad experience in analytical development from early development to commercial launch, and in-depth technology understanding for biologics products are the key in this role, which will expand our rapidly growing Oceanside team.

 

Specific Responsibilities:

 

• Lead the analytical sub teams for late stage development programs and manage all technical aspects including but not limited to risk management, strategic planning and timeline management.

 

• Proactively engage in collaboration with internal and external stakeholders to incorporate good practice and industrial trend into analytical development and control strategies.

 

• Serve as an analytical representative on pharmaceutical development project teams, and present key analytical topics.

 

• Provide analytical oversight of the external testing site activities and work closely with CXO teams to ensure the timelines and deliverables including protocol/report review and approval, SOW and contract review.

 

• Perform technical review for the analytical documents related to method development/validation, RS qualification, comparability studies, specifications, product characterization, CQA assessment, batch release and stability studies

 

• Author analytical related regulatory dossiers and participate in the preparation of regulatory meetings if needed.

 

• Support inspection readiness activities and associated health authority inspections.

 

• Perform critical data review, design the relevant studies and provide directions for troubleshooting and investigation.

 

• Support the outsourcing group for technical evaluations.

 

• Work closely with the cross functional groups to achieve the project goals.

 

Experiences and Skills:

 

• Must have late stage development knowledge and BLA experience.

 

• Broad and direct experience of managing a variety of analytical activities including analytical method development and validation, reference standard, product characterization, comparability and CQA assessments.

 

• Proven experience with managing CMO/CRO relationships and projects

 

• Practical working knowledge of cGMP; capable of assessing compliance to quality requirements using sound judgment and risk management.

 

• Familiar with ICH regulations and FDA/EMA requirements and expectations, experience with health authority inspections is desirable.

 

• Be an effective communicator of ideas, project goals and results to team members across cross-functional roles/departments.

 

• Be self-motivated and organized, ability to prioritize multiple projects and excellent problem-solving skills.

 

• Must think critically and creatively and be able to work independently and collaboratively with others.

 

• Excellent communication skills (both verbal and technical) and strong interpersonal skills are required.

 

• Innovative, proactive, and resourceful; committed to quality and continuous improvement.

 

Education:

 

• Ph.D. in Biological Sciences, Chemistry, Chemical engineering, Pharmaceutical Sciences, or relevant field with ≥ 7 years of industry experience.

 

• BS or MS degree with extensive industry experience.

 

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 mailto: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

 

https://www.dol.gov/sites/dolgov/files/WHD/legacy/files/eppac.pdf

 

YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

 

https://www.dol.gov/sites/dolgov/files/WHD/legacy/files/fmlaen.pdf

 

PAY TRANSPARENCY NONDISCRIMINATION PROVISION

 

https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf

 

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.

 

To apply, visit: https://apptrkr.com/1990610

 

To apply, visit https://apptrkr.com/1990610

 

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