MSAT Senior Associate: Tech Transfer & Process Development

Simtrabps; Bloomington (IN); On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

Medical & Dental Coverage

401(k) Retirement Savings Plan with 1:

Paid Holidays and PTO

Education Assistance

Job summary

Simtra BioPharma Solutions (Simtra) seeks an MSAT Senior Associate to drive onboarding and process development for new drug products. You will lead cross-functional teams, develop technical transfer plans, and support PPQ strategies on the path from development to commercial transfer.

In this role, you will own deviation investigations, CAPA, change control, and regulatory interactions as a subject matter expert, ensuring batch release readiness and quality compliance across projects.

Qualifications

• Bachelor’s degree required in a science or engineering field.
• In-depth knowledge of aseptic processing, sterile filtration, and clinical manufacturing.

Responsibilities

• Lead onboarding and process development activities for new drug products.
• Serve as the lead technical expert among cross-functional teams.
• Create Technical Transfer documents and validate PPQ strategies.
• Provide technical support on the manufacturing floor and drive CAPA.
• Represent Simtra in audits and client calls as SME.

Skills

MSAT

Tech Transfer

Process Development

GMP

Education

Bachelor's degree in science/engineering

Tools

JDE

BPLM

MiniTab

Trackwise

Job description

Simtra BioPharma Solutions (Simtra) seeks an MSAT Senior Associate to drive onboarding and process development for new drug products. You will lead cross-functional teams, develop technical transfer plans, and support PPQ strategies on the path from development to commercial transfer.

In this role, you will own deviation investigations, CAPA, change control, and regulatory interactions as a subject matter expert, ensuring batch release readiness and quality compliance across projects.