California Job Vacancies
Military Veterans are Encouraged to Apply.
For Current Kite Pharma Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
Job Description
Everyone at Kite is grounded by one common goal – curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Join us in our mission!
Kite is seeking a highly motivated individual with biotechnology experience to work on innovative T-cell therapies for cancer treatment. As a Sr. Process Engineer II in Materials & Process Engineering (M&PE) group, you will have a key global role within Kite's Process Development and Technical Operations functions to help develop technical and strategic solutions for excipients, ancillary/single use materials, and critical reagents used in commercial cell therapy and viral vector manufacturing. This group is part of Global Material Sciences & Technology (MSAT) and will report to leadership in Santa Monica, CA.
Key Responsibilities (include but are not limited to):
- Provide technical subject-matter expertise (SME) and implementation for commercial excipients, ancillary/single use materials, and critical reagents across the global internal and external network sites.
- Evaluate various materials use in global manufacturing processes and support the evaluation of new or alternate materials, material change either via supplier initiated change (SIC) or change control, and ensure material readiness for introduction into commercial GMP manufacturing.
- Provide technical input into the development of requirements/specifications for new GMP materials (including excipients, ancillary/single use materials, critical reagents, etc.) and secondary source material selection in collaboration with PD, site MSAT, manufacturing, supply chain, quality assurance operations, supplier quality and external vendors.
- Review and provide technical input or support for regulatory filings, regulatory inspections or projects for regulatory commitments.
- Support the requirements, design and implementation of new GMP single-use assemblies/manifolds/technologies used in global commercial manufacturing processes, where appropriate utilize value engineering to develop project solutions.
- Analyze and identify material and process risks; and support FMEAs activities.
- Support cross-functional investigation, identification of root-causes and CAPAs at internal manufacturing sites, and external vendors in collaboration with site MSAT and supplier quality. Lead resolution of critical manufacturing material issues, as needed.
- Support the development of a continued material verification plan for existing critical raw materials utilized for cell therapy and viral vector manufacturing process.
- Collaborate with key suppliers/partners including Manufacturing, Quality, Supply Chain, Regulatory, and others within Technical Operations.
- Participate in cross-functional material project teams.
- Perform other duties as assigned.
Requirements:
- Ph.D. in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology with relevant experience or
- MA/MS in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology or MBA with 6+ years of relevant experience or
- BA/BS in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology or equivalent and with 8+ years of relevant experience
Preferred Qualifications:
- Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing, cell culture, and process development
- Practical expertise with cGMP manufacturing and regulatory regulations and requirements for pharmaceuticals or medical devices
- Successful track record as a materials SME collaborating with both internal stakeholders and external raw material suppliers
- Good understanding of excipients, ancillary/single use materials, and critical reagents utilized in cell & gene therapy and the suppliers in the space
- Good understanding of material qualification and material testing requirements
- Ability to share complex principles of knowledge with others (team member, stakeholder, external, or inspection) along with strong technical writing abilities
- Experience leading cross functional teams to obtain project deliverables is a plus
- Working knowledge of scientific and engineering principles
- Knowledge of lean manufacturing and/or six sigma principles is a plus
- Self-motivated, excellent prioritization, problem-solving and investigation skills
- Ability to function efficiently and independently in a changing environment
- Team player with excellent 360-degree communication skills
Does this sound like you? If so, please apply today!
#LI-ML1
#IND123
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 http://www.kitepharma.com . Sign up to follow @KitePharma on Twitter at http://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 careers@gilead.com for assistance.
Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Kite has made the decision to require all U.S., Canada, Australia, Singapore, and Hong Kong employees and contractors to receive the COVID-19 vaccines as a condition of employment. "Full vaccination" is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE 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.
For Current Kite Pharma Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
from California Job Vacancies https://ift.tt/794fgsx
via https://www.californiajobvacancies.com/other-general/veterans-preferred-senior-process-engineer-ii-msat-1200890535/?utm_source=rss&utm_medium=rss&utm_campaign=veterans-preferred-senior-process-engineer-ii-msat-1200890535
No comments:
Post a Comment