Senior Research Scientist II, Process Development

Employer
Gilead Sciences
Location
Oceanside, CA
Posted
Sep 13, 2021
Closes
Sep 17, 2021
Ref
2371093293
Sector
Science
Organization Type
Corporate
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.For Current Gilead Employees and Contractors:Please log onto your Internal Career Site to apply for this job.Job DescriptionSenior Research Scientist II, Process Development - Oceanside, CAGilead 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 Upstream Development group at our Oceanside facility in Southern California. We are seeking a motivated, team-oriented individual with expertise in leading early stage upstream process development, data analysis and automation, and technology development activities. Additionally, the individual will act as an upstream subject matter expert on early stage projects as well as lead various supporting activities. Finally, the successful candidate will contribute to the overall upstream development strategy as a senior leader within the group.Reporting to a Director of Upstream Development, Biologics, you will have the opportunity to lead the team that oversees early stage process development as well as related automation, data analysis, and technology development activities.Key Responsibilities:• Oversee team of scientists conducting early stage upstream development and supporting activities and support technology transfer activities for monoclonal antibody, recombinant protein, and novel platform programs. Team responsibilities include clone selection, upstream platform process fit assessment, material generation, new technology development and titer improvement, media development, process optimization, data analysis, and automation.• Review GMP and non-GMP technical documentation (batch records, SOPs, validation protocols and reports; process characterization protocols and reports).• Participate in and lead cross-functional CMC teams.• Collaborate with technical operations and biologics production teams to transfer process to and support pilot scale and clinical manufacturing upstream operations.• Contribute to and review written technical reports, present in Biologics Development and Upstream Development group meetings, and work cross-functionally to achieve common goals.• Manage direct and indirect reports and mentor junior group members while working in a flexible resourcing environment.• Support internal and external manufacturing, including travel to sites (10%).Skills/Experience:• Demonstrated excellence in early stage process development including streamlining activities from DNA to regulatory filings as well as submission of multiple filings for U.S. or external markets are required.• Previous experience working in or supporting a GMP facility is required.• Previous experience leading or supporting early stage CMC projects is required.• Previous success with media or technology development, process optimization, and production titer improvement is required.• Excellent communication, interpersonal, technical report writing, presentation, and problem solving skills required.• Strong organizational and planning skills to manage multiple parallel projects is required.• Previous direct and indirect management experience of teams with at least 5 members is required.• Demonstrated ability to own team objectives, effectively delegate responsibilities, efficiently plan and execute projects, listen to team members, and demonstrate concern for individuals' career development is highly desirable.• Extensive experience in statistics and data analysis (e.g. JMP, Spotfire) is highly desirable.• Working knowledge of automation concepts and practice (DeltaV) as well as data analysis via Spotfire, JMP, Matlab, or related programming languages are desirable.Minimum Qualifications:• 7+ years of industry experience with a PhD degree in chemical or biochemical engineering or a related discipline is required.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 ACTYOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACTPAY TRANSPARENCY NONDISCRIMINATION PROVISIONOur 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.
Full time

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