Roche Molecular Systems Work Values

Daily Duties at Roche Molecular Systems:

Managed 2 Technical Departments and 12 cGMP manufacturing and material inventory areas with a $4M operational budget; identified and implemented over $5M/year cost savings initiatives; maintained compliance audit readiness and led audits in areas of responsibility. Process Improvement and Cost Savings Initiatives •Designed facility site and coordinated transition and start up activities (transfer of personnel, equipment, inventory, process) for manufacturing site relocation; Drove project deliverables per established timelines; Controlled $52M of inventory transition, capital equipment acquisition and laboratory construction •Devised the standardization strategy as the Tech Ops Lead of the Global Procurement Cost Savings Harmonization Project ($.7M/year). Collaborated efforts with 5 international corporate sites to globally standardize purchased material, consolidate suppliers, streamline purchasing efforts and reduce material costs •Launched and implemented multiple technical raw material cost savings projects ($4.6 M/year) •Coordinated garment service contract negotiation cost reduction initiative ($.25M/year) •Authored and implemented product-contact consumables project which identified critical manufacturing components for quality inspection, decreased inventory levels by 40% ($1M) and reduced scrap by $50K/year •Orchestrated equipment maintenance (acquisition, trouble-shooting, calibration, PM and IOQ/ PQ and cleaning validation report approvals) of over 500 system components •Developed and instituted departmental metrics (KPI) tracking to monitor output, lead and process times and per cent error. Analyzed direct labor utilization and implemented both resource re-allocation and work flow improvements which resulted in a 50% reduction in lead times, a 30% decrease in error rate, and a 50% increase in overall process efficiency •Demonstrated exceptional cross-team leadership by effective collaboration with R&D, Procurement, Planning, Quality, Regulatory, Finance, Validation, Calibration, Facilities, S&E and Manufacturing to facilitate project progress and achieve corporate objectives •Designed and executed training for over 150 people in new policies and procedures •Excellent technical writing skills (Project Implementation Plans, SOPs, Non-conformance Investigations, CAPA, Production Batch Records, Change Board Submissions, Biological Product Deviation Reports) Material Logistics and Compliance Management •Centralized and managed over 1100 raw materials ($25 M), maintained a corporate accuracy KPI of > 95% •Investigated raw material and process formulation deviations, performed root cause analysis and assigned CAPA •Executed supplier corrective action requests (SCARs) for non-conforming raw material supplier batches •Facilitated material quality disposition and availability to support tight production schedules •Analyzed supplier specification and COA changes and assessed new alternate supplier qualifications. Presented recommendations to the Supplier Qualification Team and Quality Review Board. Coordinated associated Feasibility and Validation project requirements •Orchestrated cross geographical material supply and distribution to global customers •Coordinated hazardous materials importing and exporting per DOT 49CFR and International Air Dangerous Goods & Hazmat regulations. •Coordinated all raw material transfers from Development to Production and for contract manufacturing •Expedited international deliveries of development raw material with Customs brokers to meet launch timelines •Sourced and acquired material processing equipment for contract manufacturing Government Compliance •Led over 70 successful LRQA/ ISO 9001, CBER, FDA, NJDEP, EPA and OSHA audits and customer inspections with no observations cited in areas of responsibility •Enforced departmental conformance per ICH/FDA, GMP, QSR, ISO and OSHA compliance •Conducted over 100 routine inter-departmental audits •Performed Risk Management and Failure Mode and Effects Analysis (FMEA)

What they like about Roche Molecular Systems:

You highly value a work environment built on a formal structure, rules, and regulations. You do not enjoy the unpredictability of shifting priorities and deadlines that upset your routine. You require and enjoy direction, input and accountability as part of your work environment. You have a strong need to participate in making key decisions and feel left out if your superiors or co-workers do not seek your input when making decisions. You thrive on providing good customer service to both internal or external customers, and doing so makes you feel good.

Tags

operations, cGMP, project management, quality, global, compliance, Project Mangement, CAPA, Deviation Investigation, Change Mangement, Inventory Mangement, SAP, Cost Savings, Equipment, Validation, Leadership, Audits, Process Improvement, Lean Manufacturing, Technical Writing, Presentation, Training, Medical Device, IVD Diagnostics, fast paced, Trackwise, New Jersey, biotech, pharmaceutical

Skills

Presentation, Technology Solutions, Sales Support, Software Implementation, Leadership , Lean Manufacturing/Kaizen/Process Improvement, Compliance Auditing, SAP End-user Implementation /SME , Deviation Investigations, CAPA Management, Change Control Management, Technical Writing, Risk Management, Controlling Multi-million Dollar Budgets, Managing Global Cost Savings Projects, Technology Transfer, Supply Chain Management , Cross Functional Team Leadership, Inventory Management, Environment Control, Site Design and Transition Project Management, Equipment Management

These are some of the questions we asked our climbers about their experiences with Roche Molecular Systems: