Sr Process Engineer II
Job Location:
Santa Monica, CA - USA
Monthly Salary:
Posted on:
Vacancies:
Job Summary
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 T-cell 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
Key Responsibilities
Raw Material Technical Leadership
- Lead and coordinate hands-on process development (PD) and technology development activities including laboratory study design experimental execution analytical sampling plans and data interpretation.
- Communicate technical outcomes and risks to crossfunctional partners and risk assessment teams.
- Define raw material requirements qualification strategies and acceptance criteria to support technology transfer commercial launch and lifecycle management.
- Translate process quality and GMP requirements into raw material and component design specifications in collaboration with vendors and external partners.
- Perform Supplier Notification Assessments (SNAs) global projectrelated raw material change assessments and raw material deviation impact assessments.
Lifecycle Management Risk Mitigation & Crossfunctional Collaboration
- Develop implement and maintain raw material lifecycle management (LCM) strategies.
- Drive secondsource raw material initiatives to improve supply chain resiliency.
- Lead and support material FMEA CCIT Adventitious Agent and Nitrosamine risk assessments to enable regulatory filings.
- Support technical investigations supplier audits and regulatory inspection responses.
Basic Qualifications
- PhD in Biochemical Engineering Chemical Engineering Biomedical Engineering Biochemistry Material Science or a related discipline with 2 years of pharmaceutical or biotech process development experience
OR - MS in a related discipline with 5 years of relevant academic or industry experience.
Preferred Qualifications
- Familiarity with pharmaceutical regulatory requirements including those related to raw materials and singleuse systems.
- Handson experience with cell culture techniques including bioreactors cell isolation and laboratory equipment.
- Experience in aseptic processing cell passaging sampling media formulation reagent and vial management and cryopreservation.
- Proficiency in statistical design of experiments (DOE).
- Strong scientific or engineering foundation in bioprocessing scaleup/scaleout hydrodynamics mass transfer and equipment design and control.
- Understanding of cell biology principles including cell differentiation phenotype markers and metabolic pathways.
- Basic material science knowledge and material compatibility considerations in cell culture environments.
Additional Skills & Competencies
- Strong computer skills with the ability to multitask selforganize and manage competing priorities.
- Demonstrated project management experience.
- Selfmotivated accountable and willing to take on temporary responsibilities outside the initial job scope.
- Collaborative resultsoriented mindset with a positive attitude and resilience in overcoming challenges.
- Ability to thrive in a fastpaced dynamic environment with minimal direction and shifting priorities.
For additional benefits information visit:
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 disabilitygenetic 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 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 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. 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 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 systems ability to recognize and kill 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.
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
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.
Kite Pharma 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:
Required Experience:
Senior IC
About Company
Kite is dedicated to curing cancer. Learn about the science of cell therapy, our cancer research, and our cancer treatments in the pipeline.
