Principal Manufacturing Science and Technology (MSAT) Representative

About the role

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization (CDMO) specializing in sterile injectable products. With facilities in Indiana, US and Halle/Westfalen, Germany, we partner with pharmaceutical and biotech companies to bring life-changing medicines to market. Our expertise spans a wide range of delivery systems, including prefilled-syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials, and sterile crystallization. We work with biologics, small molecules, cytotoxics, highly potent compounds, and vaccines, adhering to the highest quality and regulatory standards.

The Principal Manufacturing Science and Technology (MSAT) Representative is a key member of our technical team, responsible for the onboarding and process development of new drug product projects. This role involves close collaboration with cross-functional teams, including Program Management, Sales, Supply Chain, Process Validation, and Research and Development (R&D), to ensure successful project transfer and commercialization.

Responsibilities

• Lead the onboarding and process development activities for new drug products, including supporting development studies.
• Serve as the lead technical expert within a cross-functional team, guiding technical activities, development studies, and Process Performance Qualification (PPQ) batches.
• Create technical transfer documents, such as Technical Transfer Plans, process development studies (e.g., mixing, filtration, purge studies), demonstration batch records, and PPQ master batch records.
• Participate heavily in PPQ strategy and protocol development, co-leading with the Process Validation Representative.
• Lead the hand-off to the commercial team following PPQ batches.
• Provide technical support to daily manufacturing operations, including issue resolution and process improvement initiatives on the manufacturing floor.
• Conduct Non-Conformance Report (NCR) investigations independently, including the creation, ownership, and implementation of Corrective Actions/Preventive Actions (CAPA).
• Serve as the Change Control Management (CCM) owner and perform impact assessments.
• Own fill volume dosing qualifications (FVOQ) and critically evaluate product impact to determine release criteria and regulatory compliance.
• Review Master Batch Records of junior colleagues and provide guidance.
• Act as a technical representative in regulatory, client, and internal audits as the product/process Subject Matter Expert (SME), including ownership of audit responses and related CAPAs.
• Participate independently in client calls and on-site visits to strategize and resolve project issues.
• Serve as an SOP owner and process SME.
• Perform filter troubleshooting and develop in-depth SME courses on pharmaceutical industry topics.
• Mentor new hires in Technical Services and assist with training and onboarding.

Requirements

• BS degree required, preferably in a science or engineering-related field.
• 6+ years of pharmaceutical manufacturing experience, preferably in a CDMO.
• In-depth knowledge of systems and equipment, including scales, mixing systems, aseptic formulations, fill volume limit setting, disposable formulation technology, homogeneity testing, control charting, and trend identification/response.
• Experience in aseptic processing, sterile filtration, and process validation.
• Advanced proficiency in MS Office Suite.
• Experience using enterprise software (e.g., JDE, BPLM, MiniTab, Trackwise).

Physical / Safety Requirements

• Occasional overtime work, including nights and weekends.
• Use of hands and fingers to manipulate office equipment.
• Position requires sitting for long hours but may involve walking or standing for periods of time.
• Must qualify for Grade A/B area gowning.
• Must be able to wear applicable personal protective equipment (PPE).