MSAT Process Specialist
MSAT Process Specialist
Posted on :
29-07-2025
Employer Active
1 Vacancy
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Job Description
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 $75400.00 - $92300.00.
Required Experience:
Unclear Seniority
Employment Type
Full-Time
Key Skills
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