Contract sterile injectable manufacturer with 65+ years cGMP fill/finish expertise
Simtra BioPharma is a large CDMO focused on sterile injectable manufacturing and formulation support. Their stack reflects heavy manufacturing automation—Ignition, Siemens S7, PLCs, HMI, SCADA, and analytical instruments (HPLC, ICP-MS)—paired with pharma-grade compliance tooling (Veeva, LIMS, Windows/Active Directory). They're migrating from LabVantage to LabWare LIMS, signaling a software modernization push. Manufacturing roles dominate hiring (99 of 191 active), with acute pain around GMP/CGMP compliance, downtime reduction, and operator efficiency—typical for a legacy-heavy operation scaling capacity.
Notable leadership hires: Manufacturing Group Lead, Manufacturing Lead, Equipment Lead
Simtra BioPharma operates as an independently owned CDMO spanning 1,001–5,000 employees across the United States and Germany. The company specializes in sterile fill/finish services and formulation development for pharmaceutical and biotech partners facing manufacturing bottlenecks, clinical supply constraints, demand surges, or risk mitigation needs. Core operations center on aseptic filling lines, process development, and technical support; current work includes commissioning of new production capacity, system assessments for regulatory gaps, and process validation. Quality and compliance infrastructure is central to their positioning.
Simtra runs Veeva (Vault and Dynamics 365 integration), LIMS (migrating from LabVantage to LabWare), SCADA, Ignition, and Siemens S7 PLC systems with HMI interfaces for aseptic line control and monitoring.
Key projects include aseptic filling line optimization, new production building commissioning, GMP software module implementation, process development for new drugs, system assessments for regulatory/quality gaps, and predictive maintenance initiatives.
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