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Manager, Process Development/CMC Regulatory Writing

United States - California - Santa MonicaRegulatoryRegular

Arbeitsbeschreibung

***Equity, Bonus, 401k Match, Paid Shutdowns***

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 on 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 regulatory submission plan 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
  • Support the development of policies, training and processes related to regulatory filings

Basic Qualifications:

  • PhD degree in in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology, Biology, Biochemistry with 0+ years of experience
  • MA/MS degree with 6+ years of experience in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology, Biology, Biochemistry
  • BS/BA degree with 8+ years of experience in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology, Biology, Biochemistry or
  • High School Diploma with 12+ 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
  • Proactive in identifying gaps, generating solutions, and offering support
  • 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!