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MSAT Specialist
Pay Range: $22 - $26/hr
Onsite Role in Rensselaer, NY
An MSAT Specialist supports the Drug Product Manufacturing Sciences and Technology (DP MSAT) departments through monitoring process performance, data trending, data analysis and/or laboratory testing. Provides support for the design and development of drug product processes and will be part of a team responsible for industrialization, troubleshooting and validation of drug product processes at manufacturing sites, both international and domestic.
As a Temp MSAT Specialist, a typical day might include the following:
· Performs verified data entry tasks into electronic systems in a timely and efficient manner.
· Tracks cycle time and metrics for data entry process.
· Supports the implementation, expansion and continuous improvement of Regeneron’s Application for Data Aggregation and reporting system.
· Handles quality system events pertaining to data integrity and data management such as investigations, CAPAs, Change Controls and general document approvals.
· Trends process performance to establish/improve process capability, uses data analytics and/or laboratory testing to develop metrics and ensures process is operating within intended process control strategy.
· Assista with policies, technical reports/protocols, change controls, etc. in support of cGMP activities.
· Supports efforts associated with the drug product Continued Process Verification (CPV), documentation and trending of In Process Control (IPC) initiative.
· Maintains required training status on Regeneron specific work instructions and SOPs.
· Collaborates with cross-functional teams to define and execute drug product process development and technology transfer activities.
· In collaboration with peers, procures, implements and evaluates new technologies for potential future use in the drug product process.
· Maintains an awareness of relevant equipment and technology vendors, their existing and planned offerings and their anticipated performance.
· Communicates relevant information to peers and teams.
· Supports process investigations and assists with product impact assessment for change controls and internal/external investigations, through laboratory investigations and/or data analysis.
· Continuously aims to improve processes for improved performance
To be concidered you must have the following; BS/BA in engineering or scientific discipline or equivalent combination of education and experience. Experience in a pharmaceutical/biologics cGMP environment or equivalent preferred
This role might be for you if you have the:
· Ability to work independently or as part of a team.
· Ability to communicate with transparency.
· Technical knowledge in drug product manufacturing, product development and validation preferred
This is a contract position at Regeneron with Magnit Global being the Employer.
To do our best work we need different viewpoints. Therefore, we celebrate diversity and embrace inclusion. As an equal opportunity employer, we are dedicated to building a team that represents a variety of backgrounds, perspectives, and skills. We strive to ensure that we maintain a positive and enriching work environment for all.
W2 only, no third party solicitation
