Scientist, Technical Writing

Employer
Kite Pharma
Location
Santa Monica, CA, United States
Posted
Oct 30, 2020
Ref
R0015163
Required Education
Bachelors Degree
Position Type
Full time
Kite is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.

For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job

Job Description

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 in this role, 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


Basic Qualifications:

Bachelor degree with 7+ years of experience in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology, Biology, Biochemistry or MA/MS degree with 5+ years of experience in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology, Biology, Biochemistry

Preferred Qualifications:

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

Do you want to make a real difference in the world? Come help us in our quest to cure cancer! Everyone at Kite is grounded by this common goal. 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 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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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 contactcareers@gilead.comfor assistance.

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For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.