Director Biologics Manufacturing Operations

Location
Oceanside, California
Salary
We offer a competitive salary and benefits.
Posted
May 27, 2021
Closes
Jun 26, 2021
Category
Other
Position
Director
Education
BS, MS, PHD
Hours
Full Time

We want the courageous, the self-starters, the compassionate doers, the make-it-possible-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 Director of Manufacturing Operations at our Oceanside biologics facility in Southern California. We are seeking motivated, team-oriented leaders with expertise in manufacturing of recombinant proteins. Reporting to the Sr. Director of Manufacturing and Support Operations, you will have the opportunity to lead cell culture, purification and cell bank manufacturing teams.

 

Specific responsibilities and skills for position:

  • Lead Gilead’s Biologics Manufacturing Operations organization that is responsible for cell bank generation and drug substance production of recombinant proteins
  • Provide strategic and technical leadership to the upstream, downstream and technical training teams
  • Direct the activities of the manufacturing operations group including defining, planning and implementing activities/projects related to cell banking, cell culture, purification, media and buffer prep operations to ensure production schedules are met
  • Identify and implement process improvement opportunities and/or corrective actions to increase yield, maximize capacity, improve operational efficiency, reduce costs, and ensure safety while maintaining regulatory compliance
  • Provide leadership to cross-functional teams and drive business process improvements related to manufacturing operations and future expansion
  • Direct the development of manufacturing projects and initiatives, determine metrics for success and evaluate performance against metrics
  • Partner with Gilead Biologics Process Development, Quality, Technical and Support Operations to ensure timelines, deliverables, and business operations are aligned and met 
  • Represent the department as a member of a cross-functional project team providing guidance, insight and recommendations relative to the goals and objectives of the Manufacturing operations function
  • Comply with safety and environmental rules and regulations applicable to the operations

 

Essential Duties and Job Functions:

  • Accountable for both personnel and task management
  • Demonstrates a commitment to compliance and a thorough knowledge of current Good Manufacturing Practices (cGMPs)
  • Manages key relationships with external stakeholders
  • Ensures adherence to budgets, schedules, and performance requirements

 

Knowledge, Experience and Skills:

  • 12+ years of relevant experience in the pharmaceutical industry and a BS or BA OR 10+ years of relevant experience and an advanced science degree such as MS, PhD or an advanced business degree such as an MBA
  • Has extensive experience in biotech or pharmaceutical industry
  • Signification experience with upstream and downstream bioprocessing equipment and operations from cell banking to thaw through harvest, protein purification and drug substance fill
  • In-depth understanding of cGMP requirements for clinical manufacturing, proven experience in supporting regulatory and site inspections
  • 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
  • Demonstrated influencer, including cross functionally and senior leaders
  • Demonstrates strong project participation and leadership skills
  • Demonstrates the ability to work effectively in cross-functional teams
  • Has proven prior people management experience
  • Solid background in upstream and downstream GMP operations
  • Background in disposable technology and multi-product facility is preferred
  • Prior experience in Drug Substance MFG, MSAT, and QA is preferred

     

 

We offer a competitive salary and benefits package.  Apply today at Director Biologics Manufacturing Operations (myworkdayjobs.com)

 

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