
Technical Writer, Manufacturing
United States - Maryland - FrederickManufacturing Operations & Supply ChainRegularJob Description
Kite is a cell therapy company that is focused on providing patients with highly effective, life-saving therapies. We have two commercial products, Yescarta® and Tecartus®, along with a robust pipeline of various autologous and allogeneic clinical programs.
We are seeking a highly motivated individual to join us as a Technical Writer in our state-of-the-art commercial manufacturing facility in Frederick, MD.
In this role you will be responsible for performing and coordinating all technical writing related activities for the Manufacturing group, including collaborations with key personnel in other departments to ensure proper implementation of Kite policies and procedures.
Responsibilities include (but not limited to):
Includes, but not limited to, document authoring, coordination of review and comments resolution, approval, issuance, implementation, periodic review, and retirement.
Coordination and alignment of SOP’s and other technical documents to training materials (ILT’s, CBT’s. OJT’s, etc.) to drive convergent harmonization throughout all documents.
Perform compliance assessment of procedural documents against evolving global health authority regulations and health authority inspection observations.
Synthesize feedback from SMEs/procedural document teams to identify and resolve issues to accurately document current and future processes.
Excellent writing skills with hands on approach/willingness to learn in a collaborative biotech environment. Willingness for floor time to observe procedures.
Proactively use judgment to manage risk and uncertainty, and to anticipate the need for and implement contingency plans.
Effectively participate on projects, escalate issues as necessary and identify/meet key milestones with an understanding of cGMPs.
Effectively manage and prioritize multiple documents/projects to meet dynamic needs of organization.
Work with limited guidance to manage the development of procedural documents and, seek input as needed.
Exercise sound judgment, using a risk-based approach, to ensure compliance with procedural document regulations, practices, and policies.
Ability to identify, manage, and/or escalate issues and risks to timelines.
Collects and shares best practices through direct communications and communities of practice.
Drives excellence, productivity, and efficiencies by using various tools such as Operational Excellence, scheduling, etc.
Additional duties as assigned.
These duties can be delegated to designated deputies of a satisfactory qualification level as needed. Deliver, document, and track training activities per applicable Standard Operating Procedures
Coordinate, develop, and revise of qualifications
Assist with tracking and utilization of Learning Management System (LMS)
Provide regular updates to Management on the Manufacturing Technical Writing program status and initiatives
Prepare and communicate monthly Manufacturing Training Metrics
Perform compliance self- audits, as required
Assist in change controls, CAPA’s, and deviations as needed in collaboration with Site Manufacturing Technology and Manufacturing Science & Technology Groups
Basic Qualifications:
Bachelor’s degree with 2 years of relevant experience
OR
AA degree with 4 years of relevant experience
OR
High School degree with 5 years of relevant experience
Preferred Qualifications:
Previous experience as a technical writer within the Pharma/Biotech business.
Pharmaceutical/biotechnology environment
Previous experience working with a Learning Management System
Ability to relay technical information in a concise and simple format.
Possess good interpersonal and excellent written/verbal communication skills.
Highly motivated and detailed with good organizational skills
Ability to train and mentor staff
Possess the ability to multitask and work independently or in a team environment with minimum supervision
Experience with Training, Electronic batch records (PASX) and Cell Therapy a plus.
Assumes total accountability for assigned duties
Good computer skills in word processing, spreadsheets, and database software applications, specifically MS Office (Word, Excel, PowerPoint)