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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.
Kite is seeking a Manufacturing Engineer III to support Viral Vector Clinical Operations at the Santa Monica facility in Southern California. This Individual will help coordinate logistics and operations related to day-to-day activities of at-scale production of the viral vectors in the clinical GMP pilot facility. Join a team of manufacturing engineers supporting routine to complex assignments following established Standard Operating Procedures (SOPs), Master Batch Records and current Good Manufacturing Practices (cGMPs).
Responsibilities (include but not limited to):
Work within a team of manufacturing engineers to support end to end operations for clinical viral vector production at pilot and bench scale with a primary focus on upstream production.
Partner with EHS to promote positive safety culture and ensure facility and operations are maintained at the highest level of safety.
Provide purposeful presence in the production suite to ensure compliant and efficient operation of area processes.
Responsible for planning and execution of upstream production operations as well as all related equipment and systems necessary to clean, configure, sanitize/sterilize and maintain equipment in a dynamic and fast-paced team environment.
Coordinate with downstream engineers to develop training plan and team responsibility matrix.
Perform upstream unit operations and operate related equipment such as:
o Vial thaw, shake flask, pooling operations within proper aseptic technique in a biosafety cabinet, and single use bioreactor units.
o Proficiency and routine maintenance of auxiliary equipment including but not limited to: cell counters, pH/conductivity meters, filter integrity testers, autoclave, peristaltic pumps, tubing welders and analytical equipment to support and monitor the process is required.
o Development of chromatography methods to enable column chromatography operations.
Create and revise SOPs to support CAPAs, capital projects, and continuous improvement objectives.
Good Documentation Practices (GDPs), timely and effective written and oral communication of deviations, incidents, and/or safety concerns, and all relevant housekeeping duties to ensure the work areas are kept to a high level of cleanliness and inspection readiness.
Set up and operate equipment in a ISO-7/ISO-5 clean room environment and complete all required paperwork using GDPs in a timely and accurate manner.
Interact with scientists, engineers, production staff and operations director.
Ensures that work is performed in accordance with EHS, quality, and operational standards and SOPs.
Support deviation investigations, corrective action implementation.
In-depth knowledge of quality systems, validation principles, regulatory/ICH guidelines and multi-product controls preferred.
Departmental representation as an SME (Subject Matter Expert) on cross-functional teams including Process Development, Quality Assurance and Control, Calibration, Maintenance, Validation, Supply Chain, and CMC/Regulatory teams is required.
Perform troubleshooting as necessary and take initiative in resolving issues.
Develop bill of materials and manage raw material planning and inventory for GMP and non GMP orders.
Analyze data and provide recommendations on process improvements.
Basic Qualifications:
Master’s degree in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology, or equivalent and 3+ years of relevant industry experience or
Bachelor’s degree in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology, or equivalent and 5+ years of relevant industry experience or
HS diploma and 9+ years of relevant industry experience in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology, or equivalent
Preferred Qualifications:
Prior experience in a cGMP-related industry is required, within Biopharmaceutical industry
Aseptic processing experience.
Experience with upstream unit operations and related equipment listed in the Responsibilities Section.
Previous biotechnology experience in viral vector production or upstream manufacturing of monoclonal antibodies in a clinical or commercial environment.
Knowledge of Current Good Manufacturing Practices (cGMPs).
Prior experience initiating, owning and closing out deviations, change control, CAPA’s and safety improvement projects.
Prior experience creating and revising SOPs to support projects or continuous improvement objectives.
Willingness to think outside of the box and adapt best practices to our small, but growing environment
Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
High energy level and a positive outlook coupled with the requisite willingness to do what it takes to achieve personal and organizational goals and overcome obstacles
Background or understanding of Lean concepts (5S, KanBan)
Background in disposable technology and multi-product facility requirements
Highly analytical and continuous improvement minded
Experience in both downstream and upstream process development / manufacturing
For additional benefits information, visit:
https://www.gilead.com/careers/compensation-benefits-and-wellbeing
* 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 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.
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 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 ApplicantAccommodations@gilead.com for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
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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.
Please apply via the Internal Career Opportunities portal in Workday.