Associate Director, Manufacturing Execution System

Kite Pharma, Inc. Oceanside , CA 92049

Posted 2 months ago

For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job

Job Description

The Associate Director, MES will serve as Business Owner of the Manufacturing Execution System for Kite's manufacturing site at Oceanside. The successful candidate will have at least 7+ years of experience in the biotech/pharmaceutical industry and will have demonstrated competency in leading MES deployment, implementing complex electronic manufacturing batch records and integration of MES with related business systems.

The Associate Director, Manufacturing (MES) will be a part of Kite Oceanside site leadership teams to deliver the below objectives

  • Lead Oceanside cross-functional collaboration to implement MES to meet site start up plan in terms of timeline and budget

  • Interface with vendors to define user requirements and ensure the business system design meets site specific needs

  • Execution MES deployment including defining system design requirements, generating functional specifications, creating SOPs and protocols, and supporting computer system validation

  • Translate process requirements into fully integrated electronic batch records leveraging global standard and best practices

  • Develop site business processes to support site MES systems from inventory control to batch record review including change management

  • Develop site automation engineering strategy

The MES leader will establish the site MES capabilities, represent site in global manufacturing MES core team, serve as the point of contact for all IT topics and provide linkage to global IT support, and local automation team, and will supervise a team of specialists.

Education:

Bachelors required, and preferred MS/PhD in computer science or engineering.

#LI-MH1

#IND123

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 system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.

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 Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.


icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Associate Director Validation Biologics Manufacturing

Gilead Sciences, Inc.

Posted 6 days ago

VIEW JOBS 4/17/2019 12:00:00 AM 2019-07-16T00:00 For Current Gilead Employees and Contractors: Please log onto your Internal Career Site to apply for this job. Job Description Gilead Sciences is seeking an Associate Director of Validation for their Biologics Development and Manufacturing facility in Oceanside, California. Job Responsibilities and Skills: * Accountable and responsible for the site validation program including cleaning validation, computers system validation, new equipment qualification, requalification, etc. * Manages validation department, including organizing, prioritizing and overseeing delivery against department goals and objectives * Manages and oversees department training requirements, and writes performance reviews for direct reports. Responsibilities may include developing project plans, preparing protocols, analyzing test results, and preparing technical reports. * Oversees and contributes directly to the completion of projects through the development of validation schedules, project plans, master plans, validation protocols and reports for systems that may be complex in nature to support clinical and commercial manufacturing. * Coordinates validation activities with Development, Manufacturing, Engineering, Quality, and other groups on projects. * Manages the activities of assigned validation and contract personnel to ensure the quality of completed work. * Provides technical assessment and validation approval for engineering and process changes. * Reviews protocols, reports and data tables generated by peers and contract personnel * Represents the department on cross-functional project teams. * As required, prepares regulatory submissions and presents validations to regulatory authorities during routine internal and pre-approval inspections. * Contributes to the development of new concepts, techniques, and standards. * Develops solutions to unusually complex technical problems, which require the regular use of ingenuity and innovation. * Ensures solutions are consistent with organizational objectives. * May interface with contract manufacturers to address documentation and compliance issues. May interface with regulatory agencies as required. * Writes and/or implements changes to controlled documents (e.g., SOPs, Specifications, Methods, etc.) as needed. Knowledge, Experience, and Skills: * 10+ years of relevant experience and bachelor's degree in science or related field. * 8+ years of relevant experience and a MS. * In-depth knowledge of state of the art principles and theories. * In-depth knowledge of current Good Manufacturing Practices (GMPs). * Extensive working knowledge of equipment and systems. * Extensive knowledge of industry practices. * Excellent verbal, written, and interpersonal communication skills are required. * Proven analytical and conceptual skills required. * Demonstrated ability to effectively manage multiple projects/priorities. * Ability to understand key business processes and business areas. #LI-MP1 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. Gilead Sciences, Inc. Oceanside CA

Associate Director, Manufacturing Execution System

Kite Pharma, Inc.