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ImmunityBio, Inc. is a late-stage immunotherapy company developing next-generation therapies that drive immunogenic mechanisms for defeating cancer and infectious disease. The company’s immunotherapy platform is designed to activate both the innate (natural killer cell and macrophage) and adaptive (T cell) immune systems to create long-term “immunological memory.”Position
We are seeking an experienced Technical Writer
for Cell Therapy and Vaccine biopharma drug products (hybrid - remote and onsite work). This candidate would be responsible to performing a wide variety of Manufacturing activities in support of internal GMP activities. The candidate is expected to communicate, support, and collaborate with Manufacturing leadership to assess documentation needs for the team. This position provides a unique opportunity to make an immediate impact, and lay the foundation for processes and procedures in a fast-paced dynamic environment. This position will be located at one of our clinical manufacturing facilities in El Segundo or Culver City, CA and reports to the Manufacturing Document Control Supervisor.Responsibilities
- Create, revise, and format new or existing documents (MBRs, SOPs, forms, jobs aids, technical documents, worksheets, etc.) and assists in tracking each revision
- Facilitate the review/approval of all technical documents through the electronic document management system
- Collaborate within department and cross-functionally to meet set objectives and execute against manufacturing schedule.
- Participate in regular site and Quality/Manufacturing meetings.
- Participate in audits and regulatory inspections as assigned.
- Other duties as assigned.
Knowledge / Skills / Abilities
- Bachelor’s degree in Biological Science, Chemistry, or related discipline with at least 2-4 years of document review and technical writing work experience
- Minimum of 2-4 years of experience in the Biopharmaceutical or related GMP industry.
- Good knowledge of Biologics cGMP manufacturing ideally including recombinant protein and cell therapy and/or vaccine cGMP manufacturing.
- Experience producing and organizing content with a logical flow.
- Experience with electronic document management systems.
- Experience writing, proofreading, and revising GMP documentation.
- Strong verbal, written, and interpersonal communication skills.
- Proficiency in computer use and Microsoft Office applications.
- Proven ability to work independently and analyze and resolve issues that impact quality.
- Ability to operate in a fast-paced, multi-disciplinary industrial environment while managing multiple priorities.
- All hires are based upon successful completion and passage of a background check.
ImmunityBio is a mandatory vaccination employer for COVID-19 and its variants. The Company requires that its employees be fully vaccinated as of their start date. If you require a medical or religious accommodation we will engage in the interactive process with you. Proof of vaccination will be required prior to start. If we make you an offer and you are not yet vaccinated, we will accommodate a delay in start date. ImmunityBio may also mandate that its employees receive vaccine boosters, and all accommodation laws will be followed.