Senior Manufacturing Associate

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The Manufacturing Senior Associate works as part of the manufacturing team to deliver high quality therapeutics. This role is focused on processing of cell therapy technologies where aseptic processing is of the utmost importance. This role contributes to the successful delivery of released product in support of clinical trials and commercial production.

Responsibilities

• Performs aseptic operations in a Grade A controlled environment and trains staff on aseptic operation
• Support production in a controlled environment and train staff as needed
• Under minimum supervision, executes on production batch records and according to standard operating procedures and protocols
• Under minimum supervision, assist in all areas of cell processing and related duties (stocking, inventory management, material movement and reconciliation, controlled forms management, planner entry form issuance and other tasks)
• Independently support manufacturing batch record review
• Assist in the development of manufacturing electronic batch records
• Author drafts and revision of standard operating procedures, work instructions / batch records of existing and new processes and / or equipment as needed
• Support routine maintenance and cleaning of rooms and equipment
• Execute tasks in a manner consistent with safety policies, quality systems, and GMP requirements
• Initiate work orders as needed
• Independently support initiation and investigation of minor deviations and support root cause investigations and CAPA records
• Support as SME training of staff as applicable
• Identify and implement continuous improvements
• Support NPI and process transfer activities as needed
• Execute visual inspection of final drug product
• Manage D space during production (sample handoff, material ingress as needed, print documents as needed)
• Assist the team with maintaining an up-to-date working inventory for the equipment / supplies
• Document and review appropriate paperwork, daily logs, and documentation per Good Documentation Practices, including electronic documentation
• Participate in a detailed training program and develop a training plan

Qualifications

Preferred Skills

Work Environment

Physical Requirements

Salary And Benefits

EEO Information

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBCHR@fujifilm.com).

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