Robert Bottome's Email Addresses & Phone Numbers

📖 Summary

• Supply Chain and Materials Management: Sales & Operations Planning, Demand management, Supply planning, master scheduling for drug substance and drug product production, detailed scheduling, shop floor control and warehouse logistics; • Product Life Cycle Leadership: Maximizing product launch, international market expansion, end to end risk management, COGs optimization, product presentation streamlining, line extension and new indication launch; • Operations: GMP Packaging and Aseptic filling for biologics; • Operational Excellence and Business Process Management: Cycle time and inventory buffer optimization, new product introduction timeline compression, total preventive maintenance; • Transformational Change: Safety culture, human error prevention, Class A certification.Technical Product Leader @ Technical Product Leader for the biologic Nutropin (Human Growth Hormone) and the small molecule, Esbriet. Technical Product Leaders sit on the Life Cycle Team, and are the single point of contact between Pharma Medicines Technical Operations and the rest of the company, including Commercial/Global Product Strategies. Designed and deployed Product Strategic Planning process, the first Product Strategy Review session, product risk management and issue management processes for biologics and small molecule. For Nutropin: Successful delivered FDA and EMA approval for drug substance manufacturing process upgrade (to version 1.1); tech transfers for cartridge filling and combination device manufacturing. Integrated end-to-end production planning into SAP. Investigated and implemented CAPAs to reduce complain rate. Collaborated with our partner to build sales in Europe, and Commercial to enable aggressive contracting in US. For Esbriet: integrated Intermune acquisition for Product Management, including enabling order-to-cash in major markets, and Market Authorization Holder transfer ahead of schedule. Configured supply chain to optimize flow of goods and funds. Sourced tablet development and active pharmaceutical ingredient production – production of registration batches began 4 months after the sourcing decision. From November 2013 to Present (2 years 2 months) Director, SSFP Production Services @ Accountable for 70 person team including warehouse, plant scheduling, material management, training, operational excellence and tech transfer / drug substance campaign start up teams. 2012 Drug Substance Manufacturing: 148 runs, and 19 campaign starts, commercial and clinical/E coli and CHO. Worked with end-to-end Schedule/Make/Assess and Release teams, Commercial Supply Planning and Process Development Planning to enable plan changes and manage trade offs. 2012 Drug Product Manufacturing: 189 commercial fills (100% success in 2012), 6.6 Million vials with 2 Million Inspected for Export; 98 non-commercial fills, 378 packs; 66 schedule crashes with 43 expedites (success rate: 96%) Freeze-thaw tanks: 1,357 supplied to the network, supporting 21 drug substance/drug product manufacturing sites (Roche/GNE/CMO); Operational Excellence: Focus on reliable, right first time operations including human error prevention and right first time best practices, governance model streamlining (-20% meetings), front line supervisor effectiveness (pilot in DS successful), and equipment reliability (monthly cross-functional self-analysis and target setting). Successful projects include: A3 Herceptin Inventory Team support (winner of PTB reliability project of the year) which increased available capacity by 50%. Material Operations: Developed and delivered step change in warehouse operations, including safety culture focus, and several inspection readiness gap closures (including re-furbishment of aging facility, program to catalog and dis-possess aging production assets). Five successful agency and partner audits, including European Union. Defined and deployed plan to take accountability for commercial final product shipments. From January 2009 to Present (7 years) Director, Operational Excellence @ Secured Class A Certification for SSF Production Facility comprising drug substance and drug product, commercial and non-commercial operations. Innovated reliability and agility enhancing processes including tech transfer timeline compression and asset performance improvement. From August 2007 to April 2010 (2 years 9 months) Director, Commercial Bulk and Filling @ Collaborated cross-functionally to deliver a step change in reliable aseptic operations: monthly fill window attainment improved from 25% to 85% as a result of Total Productive Maintenance, human error reduction and other effort. From November 2005 to August 2007 (1 year 10 months) Director, Packaging @ Introduced a variety of lean production techniques and tools including: 5S, visual factory, OEE measurements, FMEA and rapid change over. Drover injury and illness rate down from 15 to 3.3 using behavioral safety and improvement teams. From April 2003 to October 2005 (2 years 7 months) Associate Director, Manufacturing Systems Improvement @ Worked cross-functionally across product operations to deploy continuous process improvement fundamentals including process health metrics, root cause analysis, risk analysis and error-proofing. Developed innovative GMP training for frontline supervisors, standardized forms and logs and deployed DMI format for work instructions. From November 2000 to March 2003 (2 years 5 months) Senior Manager, Environment Health & Safety @ Engaged with manufacturing, process development, QC lab and facilities management customers to define relevant metrics, deploy safety improvement teams, deliver hazard prevention training (elevated work, electrical safety, pressure safety, confined space), and management systems for managing workplace hazards (including hazard material storage, confined space rescue, hazardous energy control and new equipment safety reviews). Negotiated and obtained a variance for lab fume hoods. From November 1999 to October 2000 (1 year) Principal Consultant @ Conducted SEMI-S2 equipment safety reviews, management system audits, business continuity an disaster management reviews and drills, and machine guarding audits for a variety of industries. Worked with a national temp agency to reduce workplace recordable injuries. From 1996 to 1999 (3 years) BA, Zoology @ University of California, Berkeley From 1980 to 1984 Robert Bottome is skilled in: Change Agent, Supply Chain Management, Operations Management, GMP, SAP, MES, Lean Manufacturing, Six Sigma, Warehouse Management, Organizational Learning, Training & Development, Employee Training, Process Improvement, Clinical Development, Cross-functional Team Leadership