Manufacturing Specialist, Technical Documentation, Cell Therapy Manufacturing

About This Role

The Manufacturing Specialist, Technical Documentation supports Cell Therapy Manufacturing by authoring and revising Standard Operating Procedures and other GMP documentation for cell therapy operations, ensuring quality and regulatory compliance. This role involves collaborating with subject matter experts, managing quality actions, and supporting audits to advance novel programs.

Responsibilities

• Author and revise Standard Operating Procedures (SOP) and associated documentation for cell therapy manufacturing in accordance with Current Good Manufacturing Practices (cGMP's)
• Work closely with department Subject Matter Experts (SME's) to align on procedural updates, tech transfers, and obtain proper reviewers/approvers on all documentation
• Ensure quality and regulatory compliance of Manufacturing GMP documentation
• Act as a liaison between manufacturing, Quality Operations, and relevant Management systems
• Assist with Tech Transfer activities
• Communicate Quality-related initiatives and actions to all functional area managers and supervisors
• Challenge and make recommendations for process improvements
• Escalate compliance concerns to management in a timely manner
• Review and approve change controls as the manufacturing representative
• Communicate with team, support resources, and management regarding issue identification and resolution
• Develop solid understanding of quality and documentation systems (BMSDocs and Infinity)
• Identify, manage, and own quality actions and drive to completion
• Develop solid understanding of Cell Therapy Manufacturing processes
• Track deliverables and manage timelines effectively
• Support internal/external audits by taking urgent action to support requests
• Assist with team metrics, identifying improvements and ensuring prompt action is taken
• Obtain access to and develop solid understanding of various electronic systems utilized by Manufacturing (MES, SAP, ValGenesis, DeltaV, Maximo etc.)

Requirements

• 3+ years experience in Biotechnology/Pharmaceutical Manufacturing Operations or Support role
• Knowledge of cGMP and manufacturing production (preferred)
• Experience authoring cGMP documentation (preferred)

Qualifications

• A Bachelor's Degree in a related field is preferred. A combination of education and relevant experience may be considered in lieu of degree.
• 3+ years in a Biotechnology/Pharmaceutical Manufacturing Operations or Support role.

Nice to Have

• Cell Therapy manufacturing experience

Skills

* Required skills

Benefits