Senior Drug Product MSAT Engineer

Regeneron Pharmaceuticals•Rensselaer, IN

3d•$78,700 - $128,700•Onsite

About The Position

Regeneron is seeking a Senior Drug Product (DP) Manufacturing Science and Technology (MSAT) Specialist to join our Process Science Drug Product Engineering department. The Drug Product Manufacturing Science and Technology (MSAT) Engineer supports equipment selection, management of equipment qualification, and process validation activities, and will be responsible for solving issues during technology transfer and cGMP start-up for internal or external manufacturing sites. They also provide on the floor support during operations, as needed, for internal or external manufacturing, reviews process data to ensure operational consistency, and provides support for investigations. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

Requirements

BS in Engineering; chemical engineering or biomedical engineering preferred
5+ years of relevant experience

Responsibilities

Provides drug product manufacturing process knowledge for new product introduction, technology transfer, process validation, process troubleshooting and issue resolution for biopharmaceutical drug products
With the support of multi-functional teams, acting as the technical lead, for technology transfer of the drug product manufacturing processes to manufacturing facilities
Tracking and reporting project milestones related to raw material/component procurement, equipment readiness, process transfer, manufacturing document creation, etc.
Reviewing and approving cGMP batch documentation (master batch records, component specifications, validation protocols, material specifications, etc.) required to support cGMP production at manufacturing facilities
Assisting with investigation and root cause determination and CAPA identification and implementation for manufacturing deviations
Trending process performance and collaborates with internal and external teams to establish/improve process performance, process capability to ensure process is operating within intended process control strategy
Authoring technical reports/protocols in support of cGMP activities
Supporting development of sampling plans for cGMP batches related to process characterization, process qualification, lot release, stability etc.
Assisting in equipment selection, qualification, and start up activities and working with manufacturing to ensure robust procedures are used for operation of equipment
Partnering with strategic sourcing/procurement to specify technical requirements associated with raw materials, components, equipment and services to ensure external vendor on time delivery
Supporting the drafting of regulatory filings and responding to regulatory information requests