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Manager - Outsourced Manufacturing, Biologics

Company: GILEAD Sciences
Location: Oceanside
Posted on: January 12, 2021

Job Description:

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 DescriptionManager --- Outsourced Manufacturing, Biologics 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 on-going 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.This role will work closely with process and analytical development teams to lead the outsourcing of development, testing and manufacturing of multiple clinical stage biologics at contract manufacturing organizations and contract testing labs globally.Main Responsibilities:Actively manage and oversee the outsourcing of analytical development, testing, cell bank generation and bulk drug substance manufacturing in partnership with analytical and process development and biologics technical and manufacturing operations. Effectively negotiate Confidentiality Agreements, Master Services Agreements and Statements of WorkPrepare, review and negotiate request for proposals (RFP) and participate in due diligence evaluations of CTLs and CMOsAct as a GSL (Gilead Site Lead) for High and Medium level partnersResponsible for purchase requisitions within Gilead---s accounting system (Oracle)Ensure accurate and on-time invoicing and payments to Gilead partnersMonitor and verify implementation of Gilead---s controlled documents at contract testing labs (CTLs) and contract manufacturing sites globallyWrite, revise and review Standard Operating ProceduresDevelop budgets and accurately report accruals to FinanceSupport business reviews with CTLs and external partnersEffectively communicate issues to management and project teamsParticipate in Operational Excellence projectsJob Functions and Duties:Organize and lead teleconferences and face-to-face meetings with CTLs; work closely with Gilead teams to manage deliverablesDevelop and maintain outsourced project timelines and ensure progress against established datesOnboard CTLs including integration into Gilead systemsMaintain oversight of financials and project deliverables associated with outsourced development and testing activitiesProactively communicate issues, project changes to key stakeholders and facilitate timely discussion and resolutionMaintain project documentationKnowledge, Experience and Skills:Prior experience in biologics analytical testing, outsourced development and contract manufacturingSpecific knowledge of analytical and testing requirements for biologic products for drug substance and drug product.Strong computer skills and experience with an ERP system and project management softwareGood understanding of activities related to the CMC development and phasing of clinical stage productsKnowledge of GMPs and associated regulations (21CFR parts 11, 210, 211, 820)Ability to lead cross functional teamsStrong people management skillsStrong negotiation, verbal and written communication skillsAbility to manage multiple programs/projects; with sound organizational and time management skillsAbility to work in a highly dynamic environment and to resolve conflict in a constructive mannerAbility to solve problems through ingenuity and collaboration with subject matter experts and other key stakeholdersAbility to work in a fast-paced environment is essentialProject management experience and/or certification are a plusThis position may require up to 10% domestic and international travelMinimum Experience and Education:7 years of experience in a biotech organization or relevant manufacturing environment and a BA or BS degree; an MA/MBA degree may be considered as 2 years of relevant experience and Ph.D. may be consider as 4 years--- experience.Relocation package available for candidates outside of the greater San Diego areaFor 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 careersgilead.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

Keywords: GILEAD Sciences, Oceanside , Manager - Outsourced Manufacturing, Biologics, Executive , Oceanside, California

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