For Current Kite Pharma Employees and Contractors:
Please log onto your Internal Career Site to apply for this job
Kite is seeking a highly motivated individual with CMC writing experience for authoring, editing and reviewing regulatory submission sections (for IND, BLA, MAA and associated regulatory filings) and RTQs. This position is part of the Process Development organization and you will be interfacing with the internal Process Development teams and authoring submission sections and responses to agency questions based off of development reports, validation reports and other technical documents. You will also interface with external Regulatory Affairs, Manufacturing and Quality teams to ensure consistency in submission content. No travel is required for this position.
Responsibilities (include but are not limited to):
Write / edit / review regulatory submission sections for new and commercial products
Author responses to agency questions within the required timeline
Address comments and support comment resolution on submission content
Maintain CMC product timelines at the direction of the operations team lead
Adhere to company Style Guide, templates, and SOPs for document development
Work with cross-functional teams to ensure production of high-quality written documents
Interact with appropriate departments to establish priorities and deadlines for technical documentation
Use experience in Process Development to identify technical inconsistencies and participate in resolution
Perform other related duties and assignments as required
Bachelor's, Master's Degree, or PhD in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology, Biology, Biochemistry or equivalent with 7+ years (Bachelors), 5+ years (Masters), 2+ years (PhD) of relevant experience
Experience participating in or leading regulatory submissions
Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing and process development
Thorough knowledge of biologics process development is essential. Cell therapy process development experience is highly desired
Knowledge of product lifecycle Product and process development, clinical trials, validation and regulatory submissions, commercial GMP manufacturing
Working knowledge of regulatory requirements for biologics, pharmaceuticals and medical devices
Must be able to function and contribute as part of a team, have excellent communication skills and contribute to team based decisions
Ability to think critically, and demonstrated troubleshooting and problem solving skills
Self-motivated and willing to accept temporary responsibilities outside of initial job description
Well-developed computer skills and fluent with Microsoft office applications
Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities
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.
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For Current Kite Pharma Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
Kite Pharma, Inc.