Principal Manufacturing Science and Technology; MSAT Representative

Principal Manufacturing Science and Technology (MSAT) Representative is part of a team responsible for mandatory technical onboarding and process development of new drug product projects at Simtra Bio Pharma Solutions.

• Lead the onboarding and process development activities for the manufacture of new drug products, including supporting development studies.
• Serve as the lead technical expert among a cross‑functional team.
• Lead cross‑functional team through technical activities, development studies and PPQ batches.
• Create technical transfer documents supporting the goal, such as Tech. Transfer Plan, process development studies and demonstration batch records.
• 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, resolve issues during manufacturing and lead process improvement activities.
• Conduct Non‑Conformance Report investigations independently and own corrective and preventive actions (CAPA).
• Own Change Control Management (CCM) and impact assessment.
• Own fill volume dosing qualifications (FVOQ).
• Critically evaluate product impact and advise 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.
• Act as technical representative in regulatory, client, and internal audits as product/process subject‑matter expert, and own audit responses and related CAPAs.
• Participate independently in client calls and on‑site visits to discuss strategy for projects and issue resolutions.
• Serve as SOP owner and process SME.
• Perform filter troubleshooting.
• Develop and present in‑depth SME courses on pharmaceutical industry topics.
• Mentor new hires in Technical Services and help with training and onboarding.

• Bachelor’s 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.
• Experience in aseptic processing, sterile filtration, and process validation.
• Advanced proficiency in MS Office Suite.
• Experience using enterprise software such as JDE, BPLM, Mini Tab, Trackwise.

• 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.