Principal Manufacturing Science and Technology (MSAT) Representative

Principal Manufacturing Science and Technology (MSAT) Representative Bloomington, Indiana, United States For over 65 years, pharmaceutical and biotech companies have partnered with Simtra BioPharma Solutions (Simtra) to bring their sterile injectable products to market. Simtra is a world‑class Contract Development Manufacturing Organization with facilities in Indiana, US and Halle/Westfalen, Germany, offering a range of delivery systems including prefilled syringes, liquid/lyophilized vials, diluents for reconstitution, powder‑filled vials, and sterile crystallization for biologics, small molecules, cytotoxics, vaccines, and more, with a strong emphasis on quality and continuous improvement. What you’ll be doing: 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 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, 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 Provide technical support to daily Manufacturing operations by being visible on the manufacturing floor, resolve issues during manufacturing and lead process improvement activities Conduct Non‑Conformance Report (NCR) investigations without assistance, as well as creation, ownership and implementation of Corrective Actions/Preventive Actions (CAPA) Change Control Management (CCM) owner and impact assessment Ownership of fill volume dosing qualifications (FVOQ) Critical evaluation of product impact and responsible for advising if product meets release criteria and regulatory requirements Participate in new project reviews to determine acceptable fit Review Master Batch Records of junior colleagues and provide guidance Technical representative in regulatory, client and internal audits as product/process Subject Matter Expert (SME), and ownership of audit responses and related CAPAs Participate independently in client calls and on‑site visits to discuss and set strategy for projects and issue resolutions SOP owner & process SME Develop and present in‑depth SME courses on pharmaceutical industry topics Mentor new hires in Technical Services and help with training and onboarding What you’ll bring: BS degree required (preferably in a science or engineering related field) 6+ years pharmaceutical manufacturing experience (preferably in a CDMO) In depthknowledge 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 Experience in aseptic processing, sterile filtration, and process validation MS Office Suite advanced proficiency Experience using Enterprise software (i.e., JDE, BPLM, MiniTab, Trackwise, etc.) Physical / Safety Requirements: 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 Must be able to wear applicable personal protective equipment (PPE) Simtra is an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic. #J-18808-Ljbffr