Robert Jannelle
Snoqualmie,WA
Summary
Operations and Quality leader with 21+ years in biotechnology, cell therapy, and vaccine manufacturing. Expert in driving operational strategy, process optimization, and operational frameworks across global operations environments. Proven track record in building high-performing teams, greenfield buildouts, enhancing efficiency, and fostering strategic partnerships. Passionate about advancing biologics manufacturing through innovative solutions and operational excellence.
Overview
2026
2026
years of professional experience
Work History
Senior Director Operations Strategy (CDMO)
Just Evotec
2024 - 12.2025
- In partnership with Quality and Operations leadership, led the development and execution of comprehensive operations strategy, focusing on scalability, efficiency, and continuous improvement that addresses current operational challenges while anticipating future needs
- Conducted in-depth analysis of current operational processes and spearheaded major initiatives to redesign and enhance business processes across the organization, including but not limited to mapping current processes, identifying inefficiencies, and leveraging data-driven insights to propose and implement more effective and scalable solutions with a goal to significantly improve productivity, reduce costs, and enhance quality
- Collaborated with cross-functional and cross-site teams to ensure strategies were aligned with overall business goals
- Regained >$500,000 in lost revenue based on complex investigation of material tracking failures.
- In partnership with Operations leadership, developed and refined key performance indicators (KPIs) and metrics that accurately reflect the efficiency, effectiveness, and overall health of operational processes
- Provided regular reports to senior management, with clear insights into initiative project status, operational performance, and strategic recommendations based on data analysis
- Designed and implemented best practices for operational excellence, leveraging technology and innovative solutions where applicable
- Managed and mentored operations team members, ensuring alignment with the company’s strategic vision and operational goals
- Developed strong relationships with key industry partners, fostering collaboration and mutual growth opportunities.
Senior Director, Manufacturing (MAB Drug Substance- CDMO)
Just Evotec
2022 - 2024
- Built manufacturing operations team overseeing CDMO manufacturing of MAB drug substances
- Recruited and hired staff to increase departmental expertise (22 to >70 staff in 9 months)
- Developed and deployed organizational structure to mature manufacturing organization
- Provided guidance and leadership to large manufacturing team of >70 staff
- Designed and implemented Tiered structure governance for functional leaders to quickly make important decisions and document output
- Led commercial readiness project to prepare manufacturing site for FDA regulatory inspection
- Developed senior manufacturing leadership team to ensure Safety, Quality and Accountability by driving Right First time Execution, Always being Prepared, and Delivering Fast
Director, Quality Operations
Novavax
01.2021 - 01.2022
- Built quality operations team overseeing external CMO manufacturing of Covid vaccine drug substance
- Recruited and hired staff to increase departmental expertise
- Developed and deployed organizational structure to continuously changing CMO landscape
- Provided leadership to large quality team
- Traveled to globally to strengthen relations between CMO and company parent
- Redesigned Change Control Review Board to ensure efficient and effective changes
- Implemented project structure to ensure efficient and successful release/disposition of drug substance to meet extremely high vaccine demand (2 billion dose/year)
Associate Director, Technical Services, Viral Vector Manufacturing
Kite Pharma
01.2019 - 01.2021
- Designed, developed and deployed commercial manufacturing of Retro viral vector into new viral vector facility
- Designed and created Technical Services department structure and philosophies for deviation, change control, CAPA, EBR, SOP and Training for new site
- New Product Introduction lead for first commercial internal viral vector at Kite which required supervision and tracking of key deliverables and milestones
- Implemented change control for a site-wide initiative that reduced cost of goods by over $60,000 per year.
- Designed and implemented decision making governance structure for functional leaders to quickly make important decisions and document output
- Founding member of Global Product Variation and Jurisdictional Control and Material
- On boarded Technical Services staff, set roles & responsibilities, ensure appropriate workload.
- Technical Services/MSAT global network member driving RACI homogeneity between 5 manufacturing sites
- Championed team culture transition and response group during COVID-19 shelter-in-place order
Partnership & Alliance Management, Quality
Amgen
01.2017 - 01.2019
- Managed 6 external partnerships for early phase, clinical and commercial product, small molecule and mabs, and out-license and Co-Development/Co-Commercialization license agreements
- Strategically maintained and negotiated quality agreements and communications between Amgen and partners
- Member of multiple Product Delivery Teams providing partner quality specific support
- Commercial launch team deliverable contributor utilizing cross-functional company-wide and partnership resources
- Designed/Implemented scalable automated document disposition managing tool with email and forecast generating capabilities to ensure Operation Excellence between six cross-functional teams
- Travel internationally in Japan and Europe presenting to partner senior leadership teams and collaborating with partner peers
- Increased organizational savviness to ensure accurate cross-functional team participation
- QMS network global team member (Ad hoc presenter in the Disposition and Complaints networks)
Manager, Validation
Amgen
01.2017 - 01.2017
- Leader of the Cleaning Validation group with direct reports
- Owner of CAPA and CCMS for clinical and commercial validation
- Negotiated service level agreement with cross functional supported area leadership
- ATO Site manufacturing and CIP/SIP subject matter expert reporting site metrics to site Quality Executive Director and Manufacturing Vice President
- DSS business performance review facilitator and SME
- Regulatory audit participation and response completion/coordination
- Designed and drove cleaning validation process harmonization project
- Additional Roles:
- Single use systems manufacturing representative, driving network and vendor collaboration for design changes and failure investigations, implementation of system updates/modifications, user feedback and coordination of training with vendors
- Site manufacturing and CIP/SIP subject matter expert. Designing, collecting and reporting site monthly metrics to VP of clinical operations and quality site head. Reporting corporate quarterly metrics to global process owner
- Clinical manufacturing Risk register lead. Risk review owner and facilitator.
Manufacturing Specialist, Process Technical Support
Amgen
01.2013 - 01.2017
- Leader in the Quality Systems group with direct report
- PQP execution of both commercial and biosimilar products into a clinical/commercial facility
- Owner of Class 2 and 3 Non-conformances for clinical and commercial products. Worked in partnership with product quality leaders, quality assurance representatives, and subject matter experts for root cause investigation and documentation of non-conforming events
- CAPA owner and implementer for clinical and commercial corrections and improvements identified during root cause investigations
- Change control owner
- Multisite and Site SOP creator, owner and trainer
- SQDIP facilitator: Conducted routine tracking of and improvements to key deliverables for the Process Technical Support group
- Provided 24 hour on call support for all associated floor activities
Senior Associate Process Development Pilot Lab
Amgen
01.2009 - 01.2013
- Automation Lead, Equipment Lead, Harvest Commissioning Lead, Molecule Lead
- Investigated and eliminated a pervasive bacterial contaminant that prevented a successful run for over three years in Pilot Plant.
- Performed up and downstream daily activities, media/buffer preparation, sampling, CIP/SIP, data analysis, and process characterization
- Subject matter expert for scale-up through harvest
- Campaign/maintenance scheduler - required cross functional collaboration
- Safety – High risk assessment lead and co-author of Pressure Fundamentals training
- Trainer of full-time staff and contractors
- Continuous improvement and operational excellence contributor
- Centrifugation and clarification process SOP creator/owner
Responsible System Owner, Facilities & Engineering
Amgen
01.2008 - 01.2009
- Acted as the responsible equipment and process owner for harvest filtration and associated equipment
- Provided 24 hour on call support for all associated floor activities
- Reviewed SOP and equipment changes
- Implemented and reviewed GMP change controls
- Managed process/operational improvement projects
Senior Associate/Shift Lead Manufacturing
Amgen
01.2004 - 01.2009
- Shift lead for perfusion, production, and harvest groups
- Followed and enforced GMP procedures for scale up of Enbrel at 2-day run rate
- Facilitated the process implementation of new molecule to make plant a multi-product facility
- Facilitated the successful validation and commissioning of scale-up reactors and systems
- Gained technical writing skills while maintaining extensive non-conformance, corrective action and preventive action database
- Regularly revised, updated, and created SOPs and Manufacturing Procedures
Education
M.S. - Biotechnology
University of Rhode Island
Providence, RI01.2012
B.S. - Biological Science
Florida State University
Tallahassee, FL01.1998
Skills
- Policy development
- Collaborative leadership
- Culture transformation
- Hoshin Kanri
- Greenfield project development
- Regulatory focused batch record optimization
- Project management
- Process improvement/Operational Excellence
- Quality lifecycle management
- Group dynamics
- Technical troubleshooting
- Global travel experience
- Standard operating procedure development
Software Skills
- Smartsheet
- Microsoft Excel
- Microsoft Project
- Microsoft PowerPoint
- Microsoft Word
- DeltaV
- PI
- Trackwise/Veeva
- Maximo
- Change Control
- LIMS
- MES
- EDM Quality
Timeline
Director, Quality Operations
Novavax
01.2021 - 01.2022
Associate Director, Technical Services, Viral Vector Manufacturing
Kite Pharma
01.2019 - 01.2021
Partnership & Alliance Management, Quality
Amgen
01.2017 - 01.2019
Manager, Validation
Amgen
01.2017 - 01.2017
Manufacturing Specialist, Process Technical Support
Amgen
01.2013 - 01.2017
Senior Associate Process Development Pilot Lab
Amgen
01.2009 - 01.2013
Responsible System Owner, Facilities & Engineering
Amgen
01.2008 - 01.2009
Senior Associate/Shift Lead Manufacturing
Amgen
01.2004 - 01.2009
B.S. - Biological Science
Florida State University
Senior Director Operations Strategy (CDMO)
Just Evotec
2024 - 12.2025
Senior Director, Manufacturing (MAB Drug Substance- CDMO)
Just Evotec
2022 - 2024
M.S. - Biotechnology
University of Rhode Island