Senior Associate Outsourced Manufacturing, Biologics Operations

Senior Associate Outsourced Manufacturing, Biologics Operations
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. Gilead’s 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 company’s five core values. That’s 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 Associate - 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 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 Work Orders
• Prepare, review and negotiate request for proposals (RFP) and participate in due diligence evaluations of CTLs and CMOs
• Responsible for purchase requisitions within Gilead's accounting system (Oracle)
• Ensure accurate and on-time payments to Gilead partners
• Monitor and verify implementation of Gilead's controlled documents at contract testing labs (CTLs) and contract manufacturing sites globally
• Write, revise and review Standard Operating Procedures
• Develop budgets and accurately report accruals to Finance
• Support business reviews with CTLs and external partners
• Effectively communicate issues to management and project teams
• Participate in Operational Excellence projects

Job Functions and Duties:

• Organize and participate in teleconferences and face-to-face meetings with CTLs; work closely with Gilead teams to manage deliverables
• Maintain outsourced project timelines and ensure progress against established dates
• Onboard CTLs including integration into Gilead systems
• Maintain oversight of financials and project deliverables associated with outsourced development and testing activities
• Proactively communicate issues, project changes to key stakeholders and facilitate timely discussion and resolution
• Maintain project documentation

Knowledge, Experience and Skills:

• Prior experience in biologics analytical testing, outsourced development and contract manufacturing
• Specific knowledge of analytical requirements for biologics based products and testing needs for drug substance and drug product.
• Strong computer skills and experience with an ERP system and project management software
• Good understanding of activities related to the CMC development and phasing of clinical stage products
• Knowledge of GMPs and associated regulations (21CFR parts 11, 210, 211, 820)
• Ability to lead cross functional teams
• Strong people management skills
• Strong negotiation, verbal and written communication skills
• Ability to manage multiple programs/projects; with sound organizational and time management skills
• Ability to work in a highly dynamic environment and to resolve conflict in a constructive manner
• Ability to solve problems through ingenuity and collaboration with subject matter experts and other key stakeholders
• Ability to work in a fast-paced environment is essential
• Project management experience and/or certification are a plus
• This position may require up to 10% domestic and international travel

Minimum Experience and Education:

• 6+ 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 area

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.