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The Head of Device SRM (Supplier Relationship Management) manages device supplier relationships. This is a strategic role that will develop and implement internal policies and be influential in decision making across major functional areas: - Develop and manage Suppliers for clinical and commercial devices - Development and implementation for legal and financial aspects of the alliance - Contribute to negotiation of contract terms and conditions, including the management of amendment....


Director Analytical Method Development & Validation (GMP BiopharmaceuticalPhD preferred or MS with LOTS (5+ mgt, 10+ GMP)Analytical Method Devt, qualification and validation experience requiredComplex and New Method workLarge Cell experience is a mustWould love to have protein Characterization and analyticsGMP and STRONG leadership (team up to 60-100), Financial Management


The Supplier Relationship Manager manages supplier relationships.Lead and be accountable to CDA, NDA, MSA, Quality agreement, and supplier agreements Follow business processes and guidelines to act as the center of excellence for legal and financial aspects of the allianceContribute to negotiation of contract terms and conditions, including the management of amendment activities.Contribute to tactical and strategic sourcing activityPrepare and facilitate quarterly business review with the....


Sr Director/Director, Manufacturing Operations who will be accountable for the manufacture of clinical and commercial supplies in accordance with cGMP and lead manufacturing operations to meet customer requirements; use metrics to monitor capacity utilization, effectiveness of operations and resource allocation and be accountable for cGMP compliance, including deviations, CAPAs and product/process investigations. Need 15+ years in pharmaceuticals, nutraceuticals or biologics manufacturing....


This position is responsible for leading upstream development projects by applying scientific knowledge and QbD principles to develop efficient and robust upstream manufacturing processes and establish product / process knowledge. They will be accountable for timely development and successful transfer of these processes to either internal or external manufacturing partners to satisfy CMC deliverables. Furthermore, this position will contribute to establishing department infrastructure and....


The Lead, Human Factors Engineering will be serve as a local leader for the Human Factors Engineering Team as it grows. This role will lead human factors work to support the development of devices and combination products for delivery of our wide portfolio of drugs and biologics. This includes leadership in human factors planning, use-related risk management, requirements development and execution of human factors research (user research, formative and summative studies).1.Responsible for....


Seeking oversight to all aspects of operation of the Quality Assurance and Quality Control Lab departments and to serve as a site agent to manage compliance to all cGMP procedures including testing requirements for manufacturing are performed in a regulatory compliant manner Seeking 10 years quality experience in pharmaceutical, biological or animal health industry with 5 years of supervisory experience. FDA experience in a manufacturing gmp environment. Will be responsible for managing 3....

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