Hiring: MSAT Senior Associate (Tech Transfer) Company: Simtra BioPharma Solutions Location: Bloomington, IN Job Posted Time: 2026-09-10 13:51:41 Employment Type: Contract / On-site Target Skills & Keywords : Elasticsearch, Microsoft Excel, Program Management, R About the job Experience: •3 years of applicable MSAT/Tech Transfer/Process Development experience. Required Skills: •Lead the onboarding and process development activities & tasks for the manufacture of new drug products, including the supporting development studies. •Serve as the lead technical expert among a cross functional team •Lead the cross functional team through technical activities, development studies and clinical and/or PPQ batches •Create Technical Transfer documents supporting this goal (Tech. Transfer Plan, Process development studies (i.e. mixing studies, filtration studies, purge studies, etc.), Demonstration batch records, GMP clinical/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. The position is visible on the Manufacturing floor, resolves issues during manufacturing and leads process improvement activities. •Conduct deviation (DEV) investigations without assistance, as well as creation, ownership and implementation of Corrective Actions/Preventive Actions (CAPA) Qualifications: •Bachelor’s degree required, preferably in a science or engineering related field. •Requires 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. •In-depth expertise in aseptic processing, sterile filtration, and clinical manufacturing and/or Process Validation •Five (5) years pharmaceutical manufacturing experience, with a minimum of 3 years of applicable MSAT/Tech Transfer/Process Development experience. •Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, MiniTab, Trackwise, etc.) •Duties will require overtime work on occasion, including nights and weekends •Use of hands and fingers to manipulate office equipment is required •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. Grade A/B access may involve standing for periods of time. •Must be able to wear applicable personal protective equipment (PPE). Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!