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ROLE SUMMARY
As a member of the Gene Therapy Manufacturing Technical Services Team the Senior Process Eng -Drug Product will play a pivotal role in process validation, launch and commercial production of Gene Therapy Drug Products manufactured in Sanford, NC. During the initial phase this role will focus on supporting the Gene Therapy facility start-up, process transfers and process validation. Following execution of process validation the scope of work will include BLA submission authoring, process performance monitoring, support for change controls and deviations as well as identification of process improvements.
ROLE RESPONSIBILITIES
- Author process and equipment descriptions, process flow diagrams
- Design technical and engineering studies, author protocols, write technical reports summarizing study results
- Author process validation protocols and reports
- Lead risks assessments.
- Establish an effective Continuous Improvement feedback loop between Operations, Project teams and the fill finish equipment vendor(s) to incorporate lessons learned
- Support change management and implementation for changes to the manufacturing processes and associated systems.
- Support for regulatory submissions and PAI readiness
- Mentor and train junior colleagues
QUALIFICATIONS
- Degree in Bioprocessing, Engineering, Molecular Biology or related discipline
- BS with a minimum of 5-8 years or MS with 3-5 years of aseptic Fill Finish unit ops experience in biopharmaceutical industry
- An in-depth knowledge of Fill Finish unit operations including aseptic processing, and visual inspection
- Drug Product Process Transfer and Validation experience
- Strong leadership, organizational planning and project management skills, in addition to technical knowledge, is required to work with multi-disciplinary teams.
- Must be self-motivated and work with minimum direction
- Excellent interpersonal effectiveness and communication skills (written and oral) are required in order to interface across management levels and departments.
Preferred
- Knowledge of statistical tools (e.g. six sigma, process capability, control charting, etc.)
- PAI readiness experience
- Experience with Single Use Systems
- Last Date to Apply for Job: 7/21/2020
- Eligible for Relocation Package
- Eligible for Employee Referral Bonus
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EEO & Employment Eligibility
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