Sr Manager, Manufacturing Viral Vector Downstream

Kite Pharma

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profile Job Location:

Oceanside, CA - USA

profile Monthly Salary: $ 143225 - 185350
Posted on: 30+ days ago
Vacancies: 1 Vacancy

Job Summary

Were here for one reason and one reason only to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. Weve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But were not finished yet.

Join Kite as we make even bigger advances in cancer therapies and help shape where our business and medical science goes next.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future you are the key driver in evolving our culture and creating an environment where every employee feels included developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.


Job Description

Responsibilities include:

  • Lead Kite Vector Downstream Manufacturing team that is responsible for safe quality and efficient buffer prep cell purification and fill & finish/packaging of vector substance production

  • Provide strategic and technical leadership as well as training coaching staff development and annual performance reviews

  • Direct the activities of Downstream Manufacturing operations groups including Production and cGmP Cleaning as strong manufacturing partners

  • Define plan and implement activities/projects related to campaign or production readiness new product introduction (NPI) and product changeover 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

  • Determine metrics for success and evaluate performance against metrics

  • Partner with Vector Process Development Quality Validation Engineering Maintenance BSO MSAT and Supply Chain (Warehouse/Materials Management/Planning) to ensure timelines deliverables and business operations are aligned and met

  • Oversight of completion and closure of all deviations CAPAs incidents and change managements within the Manufacturing department

  • Lead or 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

  • Identifies risks and creates working plans to prevent issues

  • Leads supervisors to ensure safety and compliance are adhered to by team and drives culture of operational excellence

  • Supports various governmental agencies/regulators and external and internal audits or inspections

This is an exempt (salary) position that will include weekend and off hours coverage.

Basic Requirements:

  • A Ph.D. and 0 years of experience in manufacturing in the pharmaceutical industry OR

  • A MS/MA and 6 years of experience in manufacturing in the pharmaceutical industry OR

  • A BS/BA and 8 years of experience in manufacturing in the pharmaceutical industry OR

  • A High School Diploma and 12 years of experience in manufacturing in the pharmaceutical industry

Preferred Requirements:

  • 8 years bio manufacturing management experience in a Current Good Manufacturing Practices (cGMP) bioprocess environment

  • Experience in cell banking and cell purification and fill/finish/packaging (bio-manufacturing)

  • Demonstrated influencer cross-functionally with senior leaders

  • Strong knowledge of quality systems validation principles regulatory guidelines and multi-product controls

  • Experience with Single-Use Technology scale manufacturing equipment and distributed control systems (DCS) such as DeltaV and automated process equipment

  • Experience with Clinical (Phase II/III) and Commercial production

  • Experience with Electronic Batch Records in manufacturing

  • Background in disposable technology and multi-product facility desired

  • Consistent positive attitude and demonstrated ability to learn new skills

  • Strict adherence to established safety and compliance practices and standards

  • Ability to think critically with demonstrated troubleshooting and problem-solving skills as applicable to manufacturing process documentation and equipment

  • Self-motivated and willing to accept temporary responsibilities outside of initial job description

  • Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities

  • Ability to work off hours as well as weekends as needed


The salary range for this position is: $143225.00 - $185350.00. Kite considers a variety of factors when determining base compensation including experience qualifications and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus discretionary stock-based long-term incentives (eligibility may vary based on role) paid time off and a benefits package. Benefits include company-sponsored medical dental vision and life insurance plans*.

For additional benefits information visit:

Eligible employees may participate in benefit plans subject to the terms and conditions of the applicable plans.


Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune systems ability to recognize and kill tumors. Kite is based in Santa Monica CA. For more information on Kite please visit . Sign up to follow @KitePharma on Twitter at jobs in the United States:

Kite Pharma is committed to providing equal employment opportunities to all employees and applicants for employment and is dedicated to fostering an inclusive work environment comprised of diverse perspectives backgrounds and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race color religion national origin sex age sexual orientation physical or mental disabilitygenetic 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 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 for assistance.


For more information about equal employment opportunity protections please view theKnow Your Rights poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT


Kite Pharma will not discharge or in any other manner discriminate against employees or applicants because they have inquired about discussed or disclosed their own pay or the pay of another employee or applicant. However employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information unless the disclosure is (a) in response to a formal complaint or charge (b) in furtherance of an investigation proceeding hearing or action including an investigation conducted by the employer (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.

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.


Kite Pharma provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Kite Pharma Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.


Required Experience:

Manager

Were here for one reason and one reason only to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. Weve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we...
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Key Skills

  • Lean Manufacturing
  • Six Sigma
  • Continuous Improvement
  • ISO 9001
  • Lean Six Sigma
  • Management Experience
  • Manufacturing & Controls
  • 5S
  • Manufacturing Management
  • Kaizen
  • Chemistry
  • Manufacturing

About Company

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Kite is dedicated to curing cancer. Learn about the science of cell therapy, our cancer research, and our cancer treatments in the pipeline.

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