Roberto Lotti
Steinhausen
Summary
Highly organized and motivated professional experienced in aseptic Drug Product manufacturing, with proven experience on the shopfloor and within the contract manufacturing landscape.
Pragmatic and goal-oriented professional with excellent time management and problem-solving skills. Known for reliability and adaptability, with swift capacity to learn and apply new skills. Committed to leveraging these qualities to drive a new challenge.
Overview
20
20
years of professional experience
Work History
Associate Director – Global External Manufacturing
Biogen International
09.2021 - Current
- Managed interface activities with CDMOs, covering process transfers, CMO execution of our products’ manufacturing, contracts establishment and revision. This includes ensuring that departmental goals and objectives are properly aligned to support global operations’ strategy
- Led the external supply-related aspects of due diligence activities, coordinating the evaluation of existing manufacturers’ technical capabilities, regulatory competences, quality level, production capacity, supply-related processes
- Owned the overall relationship management for the assigned CMO(s), acting as Biogen’s point of contact and interacting with the CMO’s upper management
- Contributed to resolution of operational issues e.g. deviations, corrective and preventive actions, production delays etc.; oversaw alignment of production planning with planned CMO’s production. Ownership of change control timely implementation in line with regulatory and stock management constraints. Monitoring CMOs performance according to KPIs and negotiated metrics targets with CMOs based on governance team’s input
- Facilitated technology transfer from research and development projects to commercial-scale operations, ensuring successful integration into the production environment
- Conducted comprehensive due diligence for external suppliers, assessing capabilities and compliance with regulatory standards
Rotational Asset Lead – Asset Development&Portfolio Management
Biogen International
07.2020 - 06.2024
- Work with internal stakeholders in establishing proper supply for an early-stage R&D program (from R2D transition support and Ph 1, onwards to Ph 3 readiness)
- Partner with R&D program teams and with Global Clinical Operations (GCO) to track study progress and associated information functional for the advancement of the program
- Collaborated with cross-functional teams to develop strategic asset plans and timelines for pipeline projects.
Head of External Quality Parenteral, Global External Quality
Biogen International
06.2020 - 08.2021
- Provided quality leadership and managerial support for all process-related aspects of commercial manufacturing activities performed at our Contract Manufacturing Organizations (CMOs)
- Ensured departmental goals and objectives are properly aligned to support site and global operations strategy
- Built and maintained a skilled and motivated team of Quality Engineers, proactively coaching and fostering development plan of team members
- Developed effective partnerships across the organization at all levels, including senior management
Manager, Global External Quality
Biogen International
10.2016 - 05.2020
- Provided technical/quality guidance to resolve operational issues at CMOs for Biogen's Drug Products aseptically manufactured
- Successfully contributed to numerous technology transfer projects between internal teams as well as external partners, resulting in seamless transitions without disruptions to ongoing operations
- Supported CMC functions for the review and approval of regulatory filings
- Supervised a designated number of QA Associates, supported the team members in order to guide them in their responsibilities
- Analyzed the performance of each team member and provided aid / took actions where necessary
- Assisted & trained with day-to-day activities a QA Ops team at the brand new Drug Substance plant in CH for 6 months
Sr Associate, Supplier Quality
Biogen International
06.2014 - 09.2016
- Supported multiple successful technology transfers and validation projects, leading to established commercial supply of parenteral Drug Products
- Responsible for quality aspects related to the transfer or set-up of processes for commercial/clinical large molecule bulk drug products at CMOs, including but not limited to quality agreements, risk assessments, validations protocols and reports review and approval, defining and following up on quality and performance indicators
- Managed the QA interface with manufacturing and testing partners for assigned commercial and clinical large molecule bulk drug products
- Accomplished the periodical evaluation of the performance of Contract Manufacturing Organizations in collaboration with other concerned departments
- Participated in regulatory inspections and supported regulatory inspections at CMOs
Quality Assurance Specialist / Senior Quality Assurance Coordinator
GlaxoSmithKline Manufacturing
05.2008 - 05.2014
- Coordinated a team of QA specialists in charge of QA oversight for the Freeze Drying department
- Maintained quality oversight for manufacturing processes on the shopfloor, sterile injectable forms
- Conducted training of QA staff
- Led and/or reviewed deviations/complaints investigations, CAPAs definition, change controls and KPIs
- Authored, reviewed and approved Master Batch Records, reviewed and issued local SOPs and technical reports
- Led partnership with the QA function at a partner GSK site part of the GSK Vaccines Hub
Pharmacist
Farmacie Comunali di Modena SpA
07.2007 - 05.2008
Sales Representative in Modena
Chiesi Farmaceutici
01.2006 - 01.2007
- Focused on cardiovascular and musculoskeletal system therapeutic areas
Education
2nd level University Master degree - Pharmaceutical Technologies and Regulatory Affairs
University of Parma
Parma, IT01.2008
Master’s degree (MSc) - Pharmaceutical Chemistry and Technology
University of Modena and Reggio Emilia
Modena, IT01.2005
Skills
- Able to communicate efficiently in interpersonal and professional settings, through both written and oral forms, at all levels with excellent customer service skills
- Sound understanding and knowledge of biopharmaceutical manufacturing, technical transfer, performance qualification of aseptic operations
- Capable of operating in a calm and even manner within a pressurized environment
- Management experience
- A critical mind with the ability to gather information from situations quickly
- Fully familiar with standard business operations and capable of fitting into daily operations seamlessly
- Key relationship management
- Able to efficiently prioritize diverse, competing, concurrent projects
Languages
English
Bilingual or Proficient (C2)
Italian
Bilingual or Proficient (C2)
Timeline
Associate Director – Global External Manufacturing
Biogen International
09.2021 - Current
Rotational Asset Lead – Asset Development&Portfolio Management
Biogen International
07.2020 - 06.2024
Head of External Quality Parenteral, Global External Quality
Biogen International
06.2020 - 08.2021
Manager, Global External Quality
Biogen International
10.2016 - 05.2020
Sr Associate, Supplier Quality
Biogen International
06.2014 - 09.2016
Quality Assurance Specialist / Senior Quality Assurance Coordinator
GlaxoSmithKline Manufacturing
05.2008 - 05.2014
Pharmacist
Farmacie Comunali di Modena SpA
07.2007 - 05.2008
Sales Representative in Modena
Chiesi Farmaceutici
01.2006 - 01.2007
Master’s degree (MSc) - Pharmaceutical Chemistry and Technology
University of Modena and Reggio Emilia
2nd level University Master degree - Pharmaceutical Technologies and Regulatory Affairs
University of Parma