MSAT Process Specialist - Nitto Avecia : Job Details

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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 to ensure documentation reflects current operations, industry standards, and customer expectations.
• Develop, review, and revise Master Batch Records (MBRs) to ensure documentation reflects current operations, industry standards, and customer expectations.
• Provide technical transfer support for oligonucleotide projects transitioning from process development to manufacturing.
• Support interface between Supply Chain, Process Development, Quality Control/Analytical Development, Environmental Health and Safety, and Oligo Operations to ensure successful technical transfer of scale-up and cGMP projects.
• Assist in preparing technical transfer documentation, deviations, and campaign summaries.
• Communicate effectively with various departments to facilitate efficient work activities.
• Adhere to all environmental, health, and safety policies.

Job Knowledge Required

• Bachelor's degree in Chemistry, Biology, or equivalent experience.
• Experience in a cGMP manufacturing environment with familiarity in quality change management systems.
• Knowledge of relevant manufacturing processes.
• Ability to draft clear and informative documentation.
• Strong communication skills.
• Detail-oriented and self-motivated.
• Proficient in Microsoft Office.

The annual salary range is $75,400 - $92,300.

• Mid-Senior level

• Full-time

• Pharmaceutical Manufacturing

This job posting is active. No indication of expiration is present.