Technical Writer, CMC

Kite Pharma, Inc. Santa Monica , CA 90405

Posted 3 weeks ago

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 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

Requirements:

  • 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

#LI-MH1

#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 www.kitepharma.com. Sign up to follow @KitePharma on Twitter at 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.

For more information about equal employment opportunity protections, please view the 'EEO is the Law' 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.


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Technical Writer, CMC

Kite Pharma, Inc.