Associate Director, MS&T (CPV & Global Validation)

Location
Morris Plains, New Jersey
Salary
We offer a competitive salary and benefits package.
Posted
May 27, 2021
Closes
Jun 26, 2021
Category
Other
Position
Director
Education
BS, MS
Hours
Full Time

We want the determined, the big dreamers, the hopeful explorers, the we’ve-got-this-ers. Because those are the kind of people who are best able to make an impact for people with cancer. So, what’s missing? Just someone like you.

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.

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 CPV 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.

     

We offer a competitive salary and benefits package.  Apply today at  Associate Director, MS&T (CPV & Global Validation) (myworkdayjobs.com)

 

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