Nov 15, 2019

Manufacturing Lead (Purification, Small Scale Manufacturing) (Night Shift)

  • Professional Diversity Network
  • Research Triangle Park, Durham, NC, USA
Full-Time Manufacturing

Job Description

Biogen

Job Description

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 resource allocation. This includes production, validation or other project activities. Also, responsible for proper information sharing at shift exchange and ensure all issues are communicated appropriately.
* Documents/records and reviews cGMP data and information (including documentation of deviations) for processing steps and/or equipment activities, following standard operating procedures. Develops and/or revises documents as needed. Key documentation includes batch records, SLRs, and equipment logbooks. Ensure completeness of BPR/SLR real time review.
* Actively participates in training activities, managing their own individual training plan. Provides training to other associates as required and shares knowledge with others. Observes performance of employees, provides timely and targeted coaching for employees, and provides feedback to Supervisor mid and end of year.
* Initiates / investigates deviations, develops and implements corrective and preventative actions as required by supervisor. Leads and/or actively participates in troubleshooting. Serves as possible SME for audits.

Qualifications

The desired candidate should be highly detailed oriented with excellent documentation skills and exceptional troubleshooting abilities. The incumbent is expected to be an expert on multiple unit operations, have excellent technical understanding of the pr

Additional Information

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.

States

NC  

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