Manager, Manufacturing Science & Technology
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At a glance
Job overview
Amneal Pharmaceuticals is hiring a Manager, Manufacturing Science & Technology. The Manager, Manufacturing Science & Technology provides technical leadership and hands‑on support for sterile manufacturing operations, ensuring processes are scientifically sound, validated, robust, compliant, and continuously improved while acting as a bridge among Manufacturing, QA, QC Microbiology, Engineering, Validation, Regulatory Affairs, Supply Chain, and Product Development.
Key focus areas include Provide technical support for sterile operations including BFS, prefilled syringes, bag filling, formulation, filtration, aseptic transfers, filling setup, container closure, and visual inspection, Lead or support validation lifecycle activities such as PPQ, CPV, monitoring, trending, and manage tech transfer, scale up, site transfer, new product introduction, and lifecycle management, and Serve as MS&T SME for deviations, non‑conformances, OOTs, failures, yield losses, and contamination events; lead investigations, impact assessments, CAPAs, and batch disposition support.
Important skills include Sterile Manufacturing Operations, Blow Fill Seal, Prefilled Syringe Filling, Sterile Bag Filling, Formulation, and Sterile Filtration.
Skills & qualifications
Skills
Full job description
Description:
This role provides technical leadership and hands on support for sterile manufacturing operations, including Blow Fill Seal, prefilled syringe filling, sterile bag filling, formulation, sterile filtration, aseptic processing, component preparation, visual inspection, and related process interfaces. This role ensures sterile processes are scientifically sound, validated, robust, compliant, and continuously improved, serving as a technical bridge between Manufacturing, QA, QC Microbiology, Engineering, Validation, Regulatory Affairs, Supply Chain, and Product Development/Technology Transfer.
Essential Functions:
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Provide technical support for sterile operations (BFS, prefilled syringes, bag filling, formulation, filtration, aseptic transfers, filling setup, container closure, visual inspection)
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Lead or support validation lifecycle activities (PPQ, CPV, monitoring, trending) and manage tech transfer, scale up, site transfer, new product introduction, and lifecycle management
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Serve as MS&T SME for deviations, non conformances, OOTs, failures, yield losses, contamination events; lead investigations, impact assessments, CAPAs, and batch disposition support
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Establish and improve control strategies (CPPs, CQAs, IPCs, parameters, criteria) and support contamination control, APS, EM trending, cleanroom controls, and sterile assurance investigations
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Partner with Engineering, Manufacturing, Validation, QA, and Automation on equipment qualification, process improvements, facility upgrades, and manufacturing readiness; lead or support change control assessments
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Author/review technical documents (protocols, reports, SOPs, risk assessments, CPV, investigations), support audits and regulatory inspections, and provide technical coaching to junior staff and project teams
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