Manufacturing Engineer III - Viral Vector Downstream Formulation
Manufacturing Engineer III - Viral Vector Downstream Formulation
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$ 115260 - 149160
1 Vacancy
Job Description
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 Tcell 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
Kite is seeking a Manufacturing Engineer to support Viral Vector Clinical Operations at the Santa Monica facility in Southern California. We are seeking motivated teamoriented candidates to join a fastpaced team of scientists and engineers to conduct operations related to viral vector purification and formulation. 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 primarily support downstream and formulation operations for clinical viral vector production at scale with cross training into upstream production activities.
- Safety and Compliance are the two primary objectives of manufacturing operations. Expected duties include the planning and oversight of safe compliant and efficient operation of area processes.
- Responsible for daytoday planning and of all Downstream production operations as well as all related equipment and systems necessary to clean configure sanitize/sterilize and maintain equipment in a dynamic and fastpaced team environment.
- Works in conjunction with other manufacturing engineers under the guidance of the team Lead.
- Perform downstream unit operations and operate related equipment such as:
- Harvest depth filtration column chromatography sterile filtration UFDF Final fill 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 ISO7/ISO5 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.
- Indepth knowledge of quality systems validation principles regulatory/ICH guidelines and multiproduct controls preferred.
- Departmental representation as an SME (Subject Matter Expert) on crossfunctional teams including Process Development Quality Assurance and Control Calibration Maintenance Validation Supply Chain and CMC/Regulatory teams is required.
- Perform troubleshooting as necessary and takes initiative in resolving issues.
Basic Qualifications:
- Masters degree and 3 years of relevant industry experience
- Bachelors degree and 5 years of relevant industry experience
- HS diploma and 9 years of relevant industry experience
Preferred Qualifications:
- Prior experience in a cGMPrelated industry is required within Biopharmaceutical industry
- Aseptic processing experience.
- Experience with downstream 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 CAPAs 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 multiproduct facility requirements
- Able to lift equipment up to 25 lbs.
For additional benefits information visit:
Gilead Sciences Inc. 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 nonjob 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 for assistance. NOTICE: EMPLOYEE POLYGRAPH PROTECTION 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. Please apply via the Internal Career Opportunities portal in Workday.
Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid longterm 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 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:
For more information about equal employment opportunity protections please view theKnow Your Rights poster.
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Employment Type
Full-Time
