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The Senior Manager, Technical Operations oversees all process and manufacturing engineering operations to support manufacturing and quality in full compliance with GMP and other regulations; oversees design specification, contract negotiation, timelines and execution of numerous projects to enhance and maintain facility; optimizes the deployment of internal talent and utilization of contractors; promotes safety, compliance, best practices, engineering standards and resource optimization. This individual is responsible for being a champion for a safe work environment and developing objectives that improve the safety culture within their team and the site. Join our talented workforce, where a commitment to excellence and a customer focused attitude is everything. We pursue excellence because our work has the power to improve patients’ lives with the pharmaceuticals we develop and manufacture.  Responsibilities
• Attend Senior Staff meetings to develop and drive initiatives for achieving company goals
• Give presentations to prospective clients on process engineering capabilities
• Review client audit findings and implement corrective action where applicable
• Ensure project milestones are met and monthly deliverables are achieved
• Attend all project kick off meetings to appropriately set client expectations and ensure standardized approaches to tech transfer
• Reviews and approves validation protocols and final reports for client specific equipment and aseptic processing
• Ensures on-going process capability improvement
• Participates in self-development activities and training
• May establish and maintain systems to track department deliverables and trend performance against metrics
• Ensure unit’s compliance with GMP and all of its related elements such as documentation (SOP’s and validation protocols, etc.)
• Complete annual performance appraisal for direct reports
• Develop weekly/monthly goals and manages activities through direct reports

• Bachelor’s Degree in Biology, Chemical Engineering or related discipline strongly preferred; experience in lieu of degree may be considered
• 10+ years’ experience in pharmaceutical/biotechnology industry, experience in a cGMP/FDA regulated environment required
• Experience with clean room personnel, material flows, and aseptic processing regulatory requirements
• Knowledge of cleanroom process flows and process design; I.E. biodisposable strategies, sterile filtration, mixing strategies, fluid transfer to and from various compounding vessels/biobags
• Specialty knowledge of UF/DF, liposomal compounding/formulation strategies (ethanolic injection, extrusion), high shear mixing strategies, emulsions, suspensions, micronization techniques
• Current in cGMPs and how to implement management systems that promote cGMP compliance
• Ability to work with minimal

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