Senior MSAT Leader: Process Transfer & Validation

Simtra BioPharma Solutions; Bloomington (IN); On-site; USD 85,000 - 110,000; Full time

Job summary

Simtra BioPharma Solutions in Bloomington, Indiana is seeking a Principal Manufacturing Science and Technology (MSAT) Representative to lead the onboarding and process development for new drug products. The ideal candidate will have over 6 years of experience in pharmaceutical manufacturing, preferably within a CDMO.

Your role will involve providing technical support, conducting investigations, and mentoring new hires in Technical Services, as well as being a subject matter expert during audits.

Qualifications

• 6+ years of pharmaceutical manufacturing experience, preferably in a CDMO.
• In-depth knowledge of systems like scales and mixing systems.
• Advanced proficiency in MS Office Suite.

Responsibilities

• Lead onboarding and process development for new drug products.
• Provide technical support and lead process improvements.
• Conduct NCR investigations and manage CAPA implementations.

Skills

Pharmaceutical manufacturing experience

Aseptic processing

Process validation

MS Office Suite proficiency

Education

BS degree in science or engineering

Tools

JDE

BPLM

MiniTab

Trackwise

Job description

Simtra BioPharma Solutions in Bloomington, Indiana is seeking a Principal Manufacturing Science and Technology (MSAT) Representative to lead the onboarding and process development for new drug products. The ideal candidate will have over 6 years of experience in pharmaceutical manufacturing, preferably within a CDMO.

Your role will involve providing technical support, conducting investigations, and mentoring new hires in Technical Services, as well as being a subject matter expert during audits.