Job Description

The Manufacturing Specialist will be responsible for activities including technical writing, project management and project execution. This person is highly detailed oriented with excellent documentation skills and a continuous improvement mindset.

Responsibilities

• Subject matter expertise on manufacturing equipment and processes – must demonstrate moderate to advanced level of technical depth and process knowledge with manufacturing operations
• Authors manufacturing documentation, including batch production records, solution lot records, procedures, and work instructions to meet production schedules with a minor degree of supervision and can deliver on key stakeholder requirements
• Supports technology transfer of new products into manufacturing and communicates across functional teams
• Initiates, owns, and manages manufacturing focused change controls, CAPAs, and planned exceptions
• Project management and project execution – leads or participates in projects (moderate to complex in nature) and oversees timely execution
• Partners with cross functional groups (e.g. Manufacturing, Manufacturing Sciences, Engineering, Automation, Quality Assurance, Planning, and Materials Management) to identify continuous improvement opportunities and drives implementation

Qualifications

Manufacturing Specialist I, MFG Tech Ops:

• Bachelor’s degree of Life Sciences or Engineering preferred in addition to 2+ years of experience.

Manufacturing Specialist II, MFG Tech Ops:

• Bachelor’s degree of Life Sciences or Engineering preferred in addition to 4+ years of experience.

Experience Requirement for ALL Manufacturing Specialist I/II, MFG Tech Ops:

• Prior experience in manufacturing – parenteral filling and packaging operations, oral solid dose manufacture, and/or oligonucleotide synthesis
• Knowledge of business processes supporting manufacturing operations
• Robust understanding of quality and cGMP principles
• Understanding the roles of cross-functional groups in a manufacturing setting
• Fundamental knowledge of change control
• Intermediate to advanced skills in Microsoft Office and computer-based quality systems
• Intermediate to advanced level of technical writing skill
• Ability to interpret source process documentation and design manufacturing documents
• Excellent oral and written communication skills

Additional Information

The Manufacturing Specialist facilitates manufacturing operations by executing activities related to technical documentation, technology transfer, change control and process improvement. An understanding of manufacturing processes, equipment, and cGMP are vital to perform this position effectively.