Job Description
About The Department The Boulder Site is home to the specialized technical operations/CMC team for oligonucleotides and RNAi therapeutics. The CMC team works alongside Quality, Regulatory, Technical Operations and RNAi Early Development professionals at our Boulder, Colorado facility and works closely with our teams in Lexington, Massachusetts. Together, we are driving change. Are you ready to make a difference. The Position Novo Nordisk, CMC Boulder, is building a Phase 1 and 2 API Pilot facility for oligonucleotide manufacturing in Boulder Colorado. As such, the Quality Control team is seeking a Senior Quality Control Equipment Analyst to support both the successful start-up and ongoing operation of the Quality Control laboratory supporting early phase manufacturing. The Senior Quality Control Equipment Analyst will: Own all activities related to the establishment & operation of the Quality Control Chemistry laboratory as it relates to equipment qualification and subsequent PM’s and annual qualification. The position will also act as a back-up Global LIMS SME for the facility. This position is highly visible to Sr Management and is intended for a self-starter. This position is for a hands-on analyst familiar with Novo systems (TIMS, Global LIMS) and processes as they relate to GMP Quality Control. Relationships Reports to Senior Manager, Quality Control. Essential Functions Serve as QC lead (Equipment Responsible) for analytical equipment qualification to support the Boulder CMC API facility Perform analytical equipment qualification and preventive maintenance, including hands-on execution and/or coordination with equipment vendors when activities are outsourced Responsible for documenting the qualification and maintenance of analytical instrumentation, using Quality generated protocols and reports from the TIMS system when possible Coordinate with internal subject‑matter experts and equipment vendors to troubleshoot and resolve equipment issues Serve as the QC lead for the TIMS system a back-up for Global LIMS QC Super User Assist with material qualification as needed Develop processes, procedures and or protocols for QC lab equipment such as, but not limited to: HPLC, UHPLC, GC, Karl Fisher, UV, pH, Conductivity, TOC, endotoxin, ICP-MS and FTIR Write/revise SOPs, technical protocols, change control and other quality related documentation Lead & coach team members, other specialists, providing leadership in problem solving for process & quality issues Evaluate and support corporate initiatives for new technology and process improvements Represent Boulder QC on global and site level as needed for collaboration with other NN sites Interact closely with QC analysts, analytical development, facilities, engineering, and quality assurance to ensure alignment with relevant stakeholders Follow all safety & environmental requirements in the performance of duties Other accountabilities, as required Physical Requirements Ability to work in an open office environment with the possibility of frequent distraction. Ability to travel up to 10% of the time. Qualifications High School Diploma or GED and 8+ years of experience, or Associate's degree with 6+ years of experience, or Bachelor's degree from an accredited university and 4+ years of experience, or Master's degree and 2+ years of experience is required QC experience in a pharmaceutical or related (regulated) environment required Experience with computerized laboratory systems (TIMS, Global LIMS, etc.) preferred Demonstrated expert understanding of processes, procedures & products associated with assigned areas required. Able to perform detailed analysis of events & processes, develop appropriate responses to situational needs, & convey information/results to various organizational levels as appropriate required Excellent verbal & written communication skills, investigative writing skills, & computer skills required (MS Word, Outlook, Excel, PowerPoint, TIMS, and Global LIMS) Demonstrated experience in practical problem solving & process improvement methods required Demonstrated ability to manage multiple tasks/deadlines & prioritize properly based on process needs & events. Demonstrated effectiveness in systematic follow-up required Understand the processes and products at an advanced level required Demonstrates understanding of project management and NN gate process flow preferred Expert level of knowledge & understanding regarding departmental SOP’s & their high-level inter-relationships required (i.e. how they work together to establish a system) The base compensation range for this position is $