Associate Director, MS&T (Continued Process Verification & Global Validation)

Associate Director, MS&T (Continued Process Verification & Global Validation)
United States - New Jersey - Morris Plains

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

[' Associate Director, MS&T (Continued Process Verification & Global Validation)

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 Associate Director, MS&T at our biologics facility in Morris Plains, New Jersey. We are seeking motivated, team-oriented individuals with expertise in Continued Process Verification and Global Validation.

Job Responsibilities:

• Lead aspects of Gilead's Biologics CPV and Global Validation both internally and to external contract manufacturing organizations (CMOs).
• Recognized expert in the application of the process validation lifecycle supporting complex biologic products.
• Deep understanding of and experience establishing validation strategies compliant with current European and US FDA guidance for process validation.
• Responsible for defining, planning and implementing activities on one or more complex projects.
• Recognized expert in the application of the process validation lifecycle supporting complex biologic products.
• Expert in technology transfer, qualification, and validation of compendial and bespoke analytical methods
• Strong planning and resource management skills in a dynamic project environment located across multiple geographies.
• Strong communication skills and a "do-what-it-takes" attitude that inspires others.
• Self-directed individual who is able to work with limited direction in a fast-paced, goal-oriented environment.
• Lead technical investigations of process deviations and assess their potential impact on product quality as well as leading discussions and influencing stakeholder acceptance of critical process and quality-based decisions.
• In-depth understanding of cGMP requirements for commercial manufacturing, experience with assisting in the generation of relevant regulatory sections of BLA and MAA filings, data capture and management, process monitoring and trending, including control charting and statistical process control, and supporting regulatory and site inspections.
• Responsible and accountable for monitoring process performance/process history and assessing process deviations both internally and at CMO sites.
• Support regulatory inspections and routine site audits as a process-specific Subject Matter Expert.
• Comply with safety and environmental rules and regulations applicable to the operations.
• Submit environmental, safety, and property damage near miss and incident reports and participate in investigations and corrective action identification.

Essential Duties and Job Functions:

• May be accountable for both personnel and task management.
• Demonstrates a commitment to compliance and a thorough knowledge of current Good Manufacturing Practices (cGMPs).
• Works on non-routine to complex problems, projects and assignments where analysis of data, procedures or operations requires evaluation of multiple factors before taking action.

Knowledge, Experience and Skills:

• Extensive experience in biotech or pharmaceuticals industry.
• Demonstrates in-depth knowledge of industry best practice and trends.
• Demonstrates in-depth knowledge of current Good Manufacturing Practices (GMPs).
• Demonstrates excellent verbal, technical writing, and interpersonal communication skills.
• Has proven analytical and conceptual skills.
• Demonstrates ability to effectively manage multiple projects/priorities.
• Demonstrates ability to understand key business processes and business areas
• Demonstrates the ability to work effectively in cross-functional teams

Basic Qualifications:

• 10+ years of relevant experience in the pharmaceutical industry and a BS or BA; or 8+ years of relevant experience and a MS.

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:
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