About the position
Durham's Technical Operations Specialist will be an energetic, technical leader with strong interpersonal, communication, and collaboration skills responsible for implementation of technology transfer process knowledge, license approval support, commercial process enhancement activities, and routine support of commercial manufacturing. This position will primarily support the upstream fermentation and downstream purification processes for the technology transfer of our HPV vaccine drug substance. Additionally, this role will contribute to the performance and results of a department, provide technical guidance, and anticipate and interpret client and/or customer needs to identify and implement solutions. Off-shift and weekend coverage will be required based on business unit needs and specific assignments. The role encompasses technical services support in the areas of equipment and automation systems, validation, deviation management and product franchise. Specific assignments may be focused in one area or span across multiple areas of focus.
Responsibilities
- Provide technical/team support for commercial technology transfer, and qualification studies associated with the development and implementation of processes, systems and facilities related to vaccine drug substance and key intermediates.
- Actively participate on cross-functional manufacturing teams to advance project goals and deliverables related to the vaccine process.
- Lead technical studies and author documentation associated with site commercialization efforts.
- Provide deep SME knowledge for manufacturing investigations support (Product and process deviations and complex material-related events).
- Support structured problems solving for in-depth process and equipment investigations.
- Support timely resolution of manufacturing disruptions.
- Collaborate with internal/external partners, e.g. Other Company sites, Global Teams, Procurement, Raw Material & Component Suppliers.
- Develop effective data analytics methodologies, including statistical process control, and deepening process understanding.
- Author, review, and/or edit technical documents to support regulatory filings including technical protocols, reports and risk assessments.
- Author and lead manufacturing and facility deviations.
- Author Change Control documentation for complex process, validation, analytical, equipment, facility/utility and/or automation changes.
- Support aspects of regulatory inspections by presenting and defending technical documentation, investigations, and change controls.
- Evaluate and develop innovative process technologies, continuous process improvements and post launch process enhancements.
- Provide post approval support and subject matter expertise support to ongoing manufacturing activities.
Requirements
- Bachelor of Science Degree in Chemical Engineering, Biochemical Engineering, Bioengineering, or related life science field with a minimum of two (2) years of relevant experience or a Master of Science Degree.
- Experience in vaccine or biologics manufacturing within a cGMP environment.
- Experience authoring technical documentation (technical investigations, protocols, reports, or change controls) within a cGMP context.
- Demonstrated systematic problem-solving skills.
- Proven leader with influence and outstanding communication (written & presentation) skills.
- Ability to foster a collaborative work environment.
Nice-to-haves
- Experience in bulk upstream and/or downstream vaccine processes within a cGMP environment.
- Experience with culture media and/or buffer formulation processes.
- Experience with Clean-in-Place and Sterilize-in-Place systems.
- Experience with technology transfer methodologies for introduction/launch of a cGMP product.
- Experience with on-the-floor cGMP manufacturing support including providing immediate responses on the shop floor to deviations and supply chain interruptions.
- Authored process change control.
- Authored deviation investigations.
- Experience with validation documentation and execution.
- Experience with SAP.
- Experience with Manufacturing Execution Systems (MES).
- Experience with Delta V.
- Ability to read Piping and Instrumentation Diagrams is desired.
- Lean Six Sigma belt certification.
- Experience with process risk assessment tools.
- Experience with responding to regulatory questions with multiple agencies (e.g.FDA, EMA).
- Experience with face to face presentation of technically complex subjects to regulatory inspectors.
