5 associate technical lead jobs found in Durham

Biogen What You'll Do The Sr Associate II will support and lead team initiatives regarding compliance, documentation, writing deviations, lab exceptions, actions, and environmental excursions. The Sr Associate II must have practical knowledge of current regulations and cGMPs to ensure all work is performed in a cGMP manner, with adherence to regulatory regulations. What You'll Do Investigate discrepancies and capture activities in writing. Ensure appropriate corrective actions are captured, as applicable, for laboratory deviations and exceptions Author technically sound moderately complex reports with minimal guidance Support laboratory operations, to include QU, and actively and effectively communicate across functional groups and levels for completion of deliverables Initiate and monitor QC laboratory documentation, such as Standard Operating Procedures and periodic review of laboratory procedures and see them through to completion May provide Quality...

Biogen About This Role As a Senior Associate I, Quality Control (QC), you will play a critical role in ensuring the integrity, accuracy, and compliance of analytical testing that supports drug substance and drug product release. What You'll Do Perform and review analytical testing for product release, stability studies, and method validation. Lead method transfer and qualification activities. Author protocols, technical reports, and change controls. Mentor peers and contribute to cross-functional process improvement initiatives. Conduct impact assessments related to compliance (e.g., global directives, audit readiness, deviations). Review and approve complex reports and data generated by others; lead complex problem-solving through facilitation and escalation when needed. Evaluate the impact of QC activities on project teams, including implications for batch release and stability data. Support setting and reporting of measurable goals, targets,...

Biogen This position follows a traditional 2-2-3 format from 6p-6a (Night Shift) About This Role: The Manufacturing Lead performs and documents daily manufacturing operations in a cGMP environment including operation of process equipment, execution of validation protocols, revising cGMP documents, ensuring compliance to cGMP, as well as maintaining equipment and facilities. This position works closely with shift Supervisor to coordinate critical activities collaboratively and utilizes resources efficiently. This is a key preparatory role for the Manufacturing Supervisor position. The Manufacturing Lead responsibilities include but are not limited to: Executes manufacturing processing steps and/or manufacturing support activities, monitoring the process against the batch record, SLR and control system. Coordinates and/or leads process steps as required, serving as a process step(s) expert. In coordination with Supervisor, schedules tasks for a given shift and plan...

Biogen This position is a M-F business hours schedule (8A-5P) and is full time on-site at our RTP facility About This Role As an Associate III, QC Raw Materials, you will play an integral role in the Quality Control Raw Materials team at the Biogen RTP Pharma site. This critical position supports functional, tactical, and operational objectives by sampling, inspecting, and testing raw materials while maintaining strict adherence to cGMP documentation standards. Your expertise in Gas Chromatography (GC) and wet chemistry will be essential as you perform compendial testing and manage data entry into electronic laboratory information management and inventory systems. Collaborating closely with QC teams, Quality, Planning, Warehouse, Validation, and Manufacturing teams, you will help ensure that operations run smoothly. Your role may also involve assisting with GMP compliance activities, investigation writing, and continuous improvement initiatives. By working independently and...

Biogen About this Role In this Parenteral Filling Manufacturing Specialist II role, you will be responsible for manufacturing support tasks including technical writing, project management, and process implementation. This position requires you to be highly detail oriented with excellent technical writing skills and a continuous improvement mindset. What You'll Do Author manufacturing documentation including procedures, work instructions, logbooks, batch production records, solution lot records management and project execution -participate in projects (simple to moderately complex in nature), facilitating timely execution. Partner with cross functional groups (e.g. Manufacturing, Manufacturing Sciences, Engineering, Automation, Quality, Planning, and Materials Management) to identify continuous improvement opportunities and drive implementation Support the technology transfer of products into manufacturing and communicate across functional teams to ensure production...