Senior MSAT: Tech Transfer & Process Development Lead

Simtra-Biopharma-Solutions

Bloomington (IN)

On-site

USD 90,000 - 130,000

Full time

14 days+

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Benefits offered by this job

Medical & Dental Coverage
401(k) Retirement Savings Plan with 会社
Time Off Program
Education Assistance Program
Employee Assistance Program
Onsite Campus Amenities

Job summary

Simtra BioPharma Solutions in Bloomington, Indiana, is hiring a MSAT Senior Associate to lead onboarding and process development for new drug products. You will work with program management, sales, supply chain, and R&D during development and transfer, reporting to the Senior Manager, Technical Transfer.

You’ll serve as a technical expert on a cross-functional team, drive PPQ strategy, and ensure smooth handoffs to commercial teams.

Qualifications

  • Bachelor’s degree in science or engineering required.
  • 5 years pharma manufacturing with 3+ years MSAT/Tech Transfer experience.
  • Deep knowledge of aseptic processing and sterile filtration.
  • Proficiency with enterprise software and QA systems.

Responsibilities

  • Lead onboarding and process development for new drug products and studies.
  • Serve as technical expert within cross-functional teams and PPQ strategy.
  • Develop and review Tech Transfer documents and master batch records.
  • Provide daily technical support on the manufacturing floor and drive process improvements.
  • Lead deviations investigations and CAPA implementations.
  • Represent Simtra in audits and client calls as SME.

Skills

Aseptic processing
Process development
Cross-functional collaboration
Technical transfer
Regulatory understanding

Education

Bachelor's degree

Tools

JDE
TrackWise
MiniTab
Microsoft Word/Excel/Outlook

Job description

Simtra BioPharma Solutions in Bloomington, Indiana, is hiring a MSAT Senior Associate to lead onboarding and process development for new drug products. You will work with program management, sales, supply chain, and R&D during development and transfer, reporting to the Senior Manager, Technical Transfer.

You’ll serve as a technical expert on a cross-functional team, drive PPQ strategy, and ensure smooth handoffs to commercial teams.

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