The PositionProvide technical expertise and leadership to support technology transfer, process optimization and lifecycle management of manufacturing processes. Partner with cross-functional teams to ensure reliable, compliant and efficient operations while driving continuous improvement, process robustness and successful product delivery in alignment with Novo Nordisk's strategic objectives and quality standards.
RelationshipsReports to Manager or above.
Essential Functions- Perform as a subject matter expert (SME) for a Drug Substance operation (e.g., production bioreactor processes, chromatography, tangential flow filtration, etc.)
- Utilize Process Development and client provided process data to review proposed GMP scale process descriptions. Create process flow diagrams from process descriptions
- Perform responsibilities associated with the evaluation, alignment and recommendation of equipment and process improvements
- Review daily processing data from GMP manufacturing to monitor process performance
- Authors and approves technical documents, such as batch records, protocols, bills of materials, sample plans, manufacturing campaign reports, operating procedures, etc
- Review technical and validation documents for accuracy and thoroughness
- Perform assessments on material changes as disclosed by suppliers
- Train others on manufacturing techniques and science/engineering principles
- Participate in client meetings offering technical support and act as the lead representative for MS&T
- Work cross functionally with Process Development, Manufacturing, Engineering, Automation, Quality Assurance, Quality Control, Supply Chain, Project Management, Validation, Facilities and other departments to effectively transfer and maintain processes in the facility
- Participate in and support strategic alignment across Biologics sites and the Bloomington site
- Work closely with manufacturing to author appropriate batch documentation and provide technical and strategic oversight associated with GMP manufacturing
- Lead and/or support the compilation of process data, including communicating project status, trend identification and delivering internal or client presentations
- Evaluate existing processes and identify process or equipment improvements to advance efficiency, consistency and competitiveness within the market
- Support the building of business case(s) for process improvement projects
- Act as the lead for technical support of risk assessments, gap analysis, deviations, change controls and CAPAs including determination of product or process impact, root-cause analysis and corrective action identification
- Responsible for motivating, coaching and developing coworkers as a subject matter expert
- Act as a mentor to lower-level team members and Co-ops/interns
- Perform other responsibilities to support group, site and network-based initiatives, as required
- Follow all safety and environmental requirements in the performance of duties
- Other duties as assigned
Physical RequirementsFrequent sitting, standing, walking, reading of written documents and use of computer monitor screen, reaching with hands and arms, talking, writing, listening. Occasional stooping, kneeling, crouching, bending, carrying, grasping. Frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 50 pounds. Must be able to work in a cleanroom environment, including being able to don cleanroom gowning, for up to 4 hours continuously. Must comply with EHS responsibilities for the position. Working conditions will be Heating Ventilation and Air Conditioned controlled. Working in a lab environment will require working with skin irritants, lung irritants, electrical equipment, sharp instruments, toxic materials and hazardous waste. Safety procedures will be followed to minimize exposure, including clean room gowning.
Qualifications- Bachelor's Degree in related field of study from an accredited university required and a minimum of four (4) years of relevant experience required
- In lieu of Bachelor's Degree with four (4) years of experience, may consider a Master's Degree in related field of study from an accredited university with a minimum of two (2) years of relevant experience required
- In lieu of Bachelor's Degree with four (4) years of experience, may consider a Doctorate Degree in related field of study from an accredited university with a minimum of zero (0) year of relevant experience required
