Sr Process Engineer I
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Job Location:
Santa Monica, CA - USA
Monthly Salary:
$ 133195 - 172370
Posted on:
3 days ago
Vacancies:
1 Vacancy
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 study outcomes to cross-functional partners and risk assessment teams to support data-driven decisions.
- Define raw material requirements qualification strategies and acceptance criteria to support technology transfer commercial launch and product lifecycle management.
- Translate process quality and GMP requirements into clear design and technical specifications for vendors and external partners.
- Perform Supplier Notification Assessments (SNAs) global project-related raw material change assessments and raw material deviation impact assessments.
Lifecycle Management Risk Mitigation & Cross-Functional Collaboration
- Develop implement and maintain Raw Material Lifecycle Management (LCM) strategies.
- Drive second-source raw material initiatives and collaborate with internal stakeholders to improve supply chain robustness and resiliency.
- Lead and support Material FMEA Container Closure Integrity Testing (CCIT) Adventitious Agent and Nitrosamine risk assessments in support of regulatory filings.
- Support deviation investigations supplier audits and regulatory inspection responses related to raw materials and consumables.
Additional Skills & Competencies
- Strong computer skills with the ability to multitask self-organize and manage competing priorities.
- Demonstrated project management experience including cross-functional coordination.
- Self-motivated accountable and willing to take on responsibilities outside the initial scope as business needs evolve.
- Collaborative results-oriented mindset with a positive attitude and resilience in overcoming technical and operational challenges.
- Ability to thrive in a fast-paced environment with minimal direction and adapt quickly to changing priorities.
Basic Requirements
- BS in a related disciplinewith at least 6 years of experience in pharmaceutical or biotechnology process development
OR
- MS in a related discipline with at least 4 years of experience in pharmaceutical or biotechnology process development
Preferred Qualifications
- PhD in Biochemical Engineering Chemical Engineering Biomedical Engineering Biochemistry Materials Science or a related discipline
- Familiarity with regulatory requirements applicable to pharmaceuticals and single-use disposable systems.
- Hands-on experience with cell culture techniques including bioreactors cell isolation and use of standard laboratory equipment.
- Experience in aseptic processing cell passaging sampling media formulation reagent and vial management and cryopreservation.
- Proficiency in statistical design of experiments (DoE) and data-driven process optimization.
- Strong scientific and engineering foundation in bioprocessing scale-up/scale-out hydrodynamics mass transfer and equipment design and control.
- Understanding of cell biology principles including differentiation phenotype markers and metabolic pathways (preferred).
- Working knowledge of materials science material compatibility and interactions with cell culture systems (preferred).
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
Key Skills
- Lean Manufacturing
- Six Sigma
- Distributed Control Systems
- Continuous Improvement
- Process Improvement
- Minitab
- Root cause Analysis
- Process Engineering
- cGMP
- Kaizen
- Programmable Logic Controllers
- Manufacturing
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.
