Senior Process Engineer I, Viral Vector Process Design

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 highly motivated Senior Process Engineer I to be an integral member of the viral vector process development team to design and characterize viral vector processes at Kite. The candidate will contribute to process development and engineering activities required to enable robust GMP manufacturing of viral vectors to support Kite’s early and late phase pipeline programs. The primary responsibilities will be to identify opportunities for process improvements, design, implement, and lead lab-based activities to mitigate risks in GMP manufacturing. The candidate is expected to interface between various Technical Operations groups (analytical development, manufacturing science and technologies (MSAT), manufacturing, supply chain, quality, technology transfer, T-cell process design) and effectively communicate study outcomes and program timeline risks along with mitigations. The Senior Process Engineer I will be an exceptional communicator, critical thinker, and will have proven effectiveness at matrix influencing in a exciting environment. Responsibilities include, but are not limited to: Design, implement and lead lab-based activities supporting process improvement studies and life cycle development Support lab implementation and develop a best practices and proactive safety culture amongst PDe staff Collaborate with Operations, Manufacturing, Autologous PDe, and MSAT teams to identify process improvement needs and develop a strategy encompassing feasibility evaluation through implementation for next generation platform processes Design, implement and analyze process characterization studies in support of late phase programs Provide hands on training of viral vector unit operations to vPDe, MSAT and manufacturing staff Become a subject matter expert of vector product and process platform historical data in order to propose process design improvements that can resolve program risks Effectively communicate process data trends, characterization results and process improvements in both written and presentation format, while working collaboratively between Process Design, Manufacturing, MSAT, and Quality The candidate should be able to make key insights to data and develop solutions (i.e. root cause identification or corrective and preventative actions (CAPAs)) in a collaborative multidisciplinary environment. Authoring of and/or reviewing of technical documentation to enable technology transfer from process development to GMP manufacturing facilities as well as regulatory filing submissions Basic Requirements: MS/MA Degree in Chemical/Biochemical Engineering, Biomedical Engineering, Biotechnology or a related discipline and 4+ years of pharmaceutical/biotech industry experience in manufacturing or process development as well as sustained excellence in performance and accomplishments that align to company goals or BS/BA Degree in Chemical/Biochemical Engineering, Biomedical Engineering, Biotechnology, or a related discipline with 6+ years of pharmaceutical/biotech industry experience in manufacturing or process development or High School Diploma with 11+ years of pharmaceutical/biotech industry experience in manufacturing or process development Preferred Requirements: Practical expertise/knowledge of cGMP manufacturing for Biologics or Viral Vector or Gene and Cell therapy products. Exceptional written and oral communication skills to a scientific and quality-focused audience Experience in managing multiple complex projects simultaneously through effective time management and with little oversight Previous experience with process design and technology transfer is preferred. Knowledge of process validation and qualification is preferred. Thorough understanding of operating and performance parameters, as well as establishing parameter ranges Previous experience with cell culture and aseptic process experience is preferred Previous experience with downstream purification operations inclusive of depth filtration, ultrafiltration/diafiltration, chromatography, and sterile filtration preferred Previous experience with final fill into bags or vials preferred Working knowledge of scientific and engineering principles Ability to think critically, and demonstrated troubleshooting and problem-solving skills based on deductive reasoning Comfortable in a exciting, small company environment with minimal direction and able to adjust workload based upon changing priorities Self-motivated and willing to accept temporary responsibilities outside of initial job description The role is site-based with primary location in Santa Monica, but need ability to travel, based on business priorities Ability to consistently demonstrate company core values of Excellence, Integrity, Inclusion, Accountability and Teamwork The ability to work effectively in a diverse, inclusive environment The salary range for this position is: $130,220.00 - $168,520.00. 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 . 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 ApplicantAccommodations@gilead.com for assistance. For more information about equal employment opportunity protections, please view the 'Know Your Rights' (https://www.eeoc.gov/employers/eeo-law-poster) poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT (http://www.dol.gov/whd/regs/compliance/posters/eppac.pdf) YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT PAY TRANSPARENCY NONDISCRIMINATION PROVISION (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp_%20English_formattedESQA508c.pdf) 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 (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.