MSAT Process Specialist

About this opportunity :

To support the transfer of development processes into GMP manufacture. Working with Project Teams, Manufacturing, and QA to progress process transfer. The ability to multi-task and accommodate shifting priorities is a must. 

Key Job Responsibilities:

• Develop, review and revise SOPs as required to assure documentation reflects current operations, meets industry standards, and meets customer expectations.
• Develop, review and revise Mater Batch records (MBRs) as required to assure documentation reflects current operations, meets industry standards, and meets customer expectations.
• Provide technical transfer support for oligonucleotide projects that move from process development to oligo manufacturing.
• Support the interface between Supply Chain (SC), Process Development, Quality control/Analytical Development (QC/AD), Environmental Health and Safety (EHS) and Oligo Operations (OPS) to ensure successful technical transfer of scale up and cGMP projects in manufacturing.
• Provide support in the preparation of technical transfer documentation, process transfer related deviations and campaign summary documentation preparation.
• Communicate appropriate information to representatives of SC, QC/AD, Business Development, Project Management, OPS, Quality Assurance, EHS and Facilities to enable efficient execution of work activities.
• Adhere to all company environmental, health and safety policies.

Job Knowledge Required:

• BS in Chemistry, Biology, or equivalent direct experience is required.
• Experience required in cGMP manufacturing environment with familiarity in quality change management systems.
• Must have knowledge of relevant manufacturing processes.
• Ability to efficiently draft clear and informative documentation for manufacturing, procurement, and quality compliance.
• Strong communication skills.
• Detail oriented and independently motivated.
• Proficient with the Microsoft Office suite.

The annualized salary for this role is $75,400.00 - $92,300.00.