As a member of the Gene and Cell therapy Technical Support Team located in Sanford, NC, the Upstream Process Engineer will play a pivotal role in the design, start-up, and verification of the Stage 2 GTx manufacturing and pilot plant facilities in Sanford, NC. The incumbent will review and approve user requirements and design specifications, support fit for use activities (FAT, commissioning, verification), and serve as an Upstream process subject matter expert.
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 process performance monitoring, support for change controls and deviations as well as identification of process improvements.
Actively contribute to scale-up, transfer and successful execution of robust gene therapy manufacturing processes
Drive application of the Right First Time co-development processes for upstream process risk assessments and control strategies
Support both late phase clinical and commercial manufacturing operations, including Tech Transfer to the Sanford Facility and facility start up activities
Contribute to Project Technical Teams, communicate and collaborate effectively to ensure effective interactions with all stakeholder groups.
Designs technical and engineering studies, writes technical reports summarizing study results and generates necessary data to support change impact assessments during process transfer and investigations.
Authors process and equipment descriptions, process flow diagrams and risks assessments.
Supports change management and implementation for changes to the manufacturing processes and associated systems.
Identifies potential process improvements projects. Leads implementation of process improvements projects and supports compliance driven projects that require technical support.
Contribute to process validation plans, protocols and reports.
Mentor and train junior colleagues
BS with in Bioprocessing, Molecular Biology or related discipline with a minimum of 5-8 years of mammalian cell culture experience in biopharmaceutical industry. PhD or MS degree preferred.
Process development or technical support for GMP manufacturing with single-use bioprocessing technologies such as WAVE bioreactor and XDR bioreactors
Strong mammalian cell culture expertise required; knowledge of other heterologous expression systems desirable
An in-depth knowledge of bioreactor operations and perfusion cell culture highly desirable
Process Transfer and Scale up Experience in GMP environment
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.
Molecular virology/ engineering and production of recombinant viruses based on transient transfection
Perfusion cell culture experience
Remains organized &; positive in ambiguous and fast-paced, rapidly changing environment
Flexible and adaptable to changing priorities, meeting deadlines, and working well under pressure and in ambiguous situations
Ability to process complex information and make recommendations with incomplete data set
Ability to adjust work schedule to meet business needs – overtime, off shift, weekends.
Ability to travel– travel time may be up to 20% according to business needs.
Other Job Details:
Last Date to Apply for Job: February 17, 2021
Eligible for Employee Referral Bonus
Eligible for Relocation package
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