Manufacturing Engineer I, Viral Vector Upstream
Gilead Sciences, Inc.
**For Current Kite Pharma Employees and Contractors:**
Please log onto your Internal Career Site (https://www.myworkday.com/gilead/d/inst/13102!CK5mGhIKBggDEMenAhIICgYI1A0QtgI~/cacheable-task/2997$2151.htmld#backheader=true) to apply for this job.
We’re 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. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're 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**
Kite is seeking a Manufacturing Engineer to support Viral Vector Clinical Operations at the Santa Monica facility in Southern California. We are seeking motivated, team-oriented candidates to join a fast-paced team of scientists and engineers to conduct operations related to viral vector production. 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 in a team to support operations for clinical viral vector production at scale.
+ Safety and Compliance are the two primary objectives of manufacturing operations. Expected duties include the planning, execution and oversight of safe, compliant and efficient operation of area processes.
+ Responsible for day to day planning and execution of all 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.
+ Works in conjunction with other manufacturing engineers under the guidance of the team Lead.
+ Perform upstream unit operations and operate related equipment such as:
+ Vial thaw, shake flask expansion, Wave bioreactor, single use production bioreactor, transfection, harvest depth filtration, and media preparation.
+ Additionally, cross training with downstream operations for column chromatography, sterile filtration, UFDF, and buffer preparation in small scale and pilot scale.
+ Proficiency and routine maintenance of auxiliary equipment including but not limited to: pH/conductivity meters, filter integrity testers, autoclave, peristaltic pumps, tubing welders and analytical equipment to support and monitor the process is required.
+ Perform aseptic operations in a Biological Safety Cabinet.
+ 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 completes all required paperwork using GDPs in a timely and accurate manner.
+ Interacts with scientists, engineers, production staff and operational lead.
+ Ensures that work is performed in accordance with quality standards and SOPs.
+ May support deviation investigations, corrective action implementation and change management initiation.
+ 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, and maintenance teams is required.
+ Perform troubleshooting as necessary and takes initiative in resolving issues.
**Basic Qualifications:**
+ Masters degree OR
+ Bachelors degree and 2+ years of relevant industry experience OR
+ AA degree and 4+ years of relevant industry experience
+ HS degree and 5+ years of relevant industry experience
**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 downstream 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/or revising SOPs to support projects or continuous improvement objectives.
+ Background or understanding of Lean concepts (5S, KanBan)
+ Background in disposable technology and multi-product facility requirements
+ Able to lift equipment up to 25 lbs.
Does this sound like you, if so apply today!
The salary range for this position is: $86,275.00 - $111,650.00. 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:
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 .
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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 ApplicantAccommodations@gilead.com for assistance.
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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 (https://www.myworkday.com/gilead/d/inst/13102!CK5mGhIKBggDEMenAhIICgYI1A0QtgI~/cacheable-task/2997$2151.htmld#backheader=true) to apply for this job.
**Change The World With Us**
Everyone at Kite is grounded by one common goal – curing cancer. Every day, we aim to establish a direct line between that purpose and our day-to-day work.
We are creating Kite together, with the recognition that the best teams are built by the best people. We maintain an attitude of curiosity, and creativity with each challenge as we develop a new market for cancer therapies. We appreciate and respect one another, and most importantly, we don’t take success for granted.
While we’ve come a long way to make what others viewed as impossible, possible, we know one thing is certain. Today is just the beginning.
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