Vacancy caducado!
For Current Kite Pharma Employees and Contractors:Please log onto your Internal Career Site (https://www.myworkday.com/gilead/d/inst/13102!CK5mGhIKBggDEMenAhIICgYI1A0QtgI/cacheable-task/2997$2151.htmld#backheader=true) to apply for this job.Job DescriptionKite 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 experienceORAA degree with 4 years of relevant experienceORHigh School degree with 5 years of relevant experiencePreferred 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)
The salary range for this position is: $73,015.00 - $94,490.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans.For additional benefits information, visit:https://www.gilead.com/careers/compensation-benefits-and-wellbeing
Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
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 [email protected] for assistance.For more information about equal employment opportunity protections, please view the 'Know Your Rights' (https://www.eeoc.gov/employers/eeo-law-poster) poster.NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT (http://www.dol.gov/whd/regs/compliance/posters/eppac.pdf)YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACTPAY TRANSPARENCY NONDISCRIMINATION PROVISION (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp%20EnglishformattedESQA508c.pdf)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 (https://www.myworkday.com/gilead/d/inst/13102!CK5mGhIKBggDEMenAhIICgYI1A0QtgI/cacheable-task/2997$2151.htmld#backheader=true) to apply for this job.Change The World With UsEveryone at Kite is grounded by one common goal – curing cancer. Every day, we aim to establish a direct line between that purpose and our day-to-day work.We are creating Kite together, with the recognition that the best teams are built by the best people. We maintain an attitude of curiosity, and creativity with each challenge as we develop a new market for cancer therapies. We appreciate and respect one another, and most importantly, we don’t take success for granted.While we’ve come a long way to make what others viewed as impossible, possible, we know one thing is certain. Today is just the beginning.
Vacancy caducado!