Manufacturing Science and Technology; MSAT

About the Role

The Manufacturing Science and Technology (MSAT) role is part of a team of experienced pharmaceutical professionals responsible for the technical onboarding and process development of new drug product projects s includes designing the process(es) required for the new project. The Tech Transfer Senior Associate will work closely with a cross‑functional group consisting of Program Management, Sales, Supply Chain, Process Validation, Research and Development (R&D), and others, during development and transfer of new projects to Simtra.

This position is 100% onsite at the Bloomington facility and reports to the Sr. Technical Transfer Manager.

• Lead the onboarding and process development activities for the manufacture of new drug products, including the supporting development studies
  • Lead the cross‑functional team through technical activities, development studies and PPQ batches
  • Create technical transfer documents supporting this goal [Technical Transfer Plan, Process Development studies (i.e. mixing studies, filtration studies, purge studies, etc.), Demonstration batch records, PPQ master batch record]
  • Heavy participation/co‑lead with Process Validation representative on PPQ strategy and protocol development
  • Lead during hand‑off to the commercial team following PPQ batches
• Provides technical support to daily manufacturing operations while being visible on the manufacturing floor and resolving issues during manufacturing
• Leads process improvement activities
• Independently conduct Non‑Conformance Report (NCR) investigations and create, provide ownership, and implementation of Corrective Actions/Preventive Actions (CAPA)
• Change Control Management (CCM) owner and impact assessment
• Ownership of Fill Volume Dosing Qualification (FVOQ) documentation
• Critical evaluation of product impact and responsible for advising if product meets release criteria and regulatory requirements
• Participates in new project reviews to determine acceptable fit
• Reviews Master Batch Records of junior colleagues and provides guidance
• Independently represents Simtra in regulatory, client and internal audits as product/process Subject Matter Expert (SME). Ownership of audit responses and related CAPAs
• Participates independently in client calls and on‑site visits to discuss and set strategy for projects and issue resolutions
• Standard Operating Procedures (SOP) owner & process subject matter expert (SME)
• Perform filter troubleshooting
• Develop and present in‑depth SME courses on pharmaceutical industry topics
• Mentors new hires in Technical Services Department and helps with training and on‑boarding

• BS degree, preferably in a science or engineering related field
• 7+ years pharmaceutical manufacturing experience
• 3+ years of applicable Technical Transfer/Process Development experience
• In-depth knowledge of systems and equipment - including scales, mixing systems and mixing monitoring methods, aseptic formulations, fill volume limit setting, disposable formulation technology, homogeneity testing, control charting, identification and response to trends
• Expertise in aseptic processing, sterile filtration, and Process Validation
• Microsoft Office Suite advanced proficiency Word, Excel, and Outlook
• Knowledge and ability to use enterprise software (JDE, BPLM, Minitab, Trackwise, etc.)

• Duties will require overtime work on occasion, including nights and weekends
• Position requires sitting for long hours but may involve walking or standing for periods of time
• Must be able to qualify for Grade A/B area gowning
• Must be able to wear applicable personal protective equipment (PPE)

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • Short and Long‑Term Disability Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
• Additional Benefits
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical…