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Management Supply Chain

Location:
San Francisco, CA
Posted:
May 02, 2016

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Resume:

Shalaka Khambalkar (MS Engineering Management, PMP, B.S.Engg, Six Sigma Green Belt)

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EXECUTIVE SUMMARY: Over 17 years of bio pharma industry experience with cross functional knowledge in various areas such as Product Security and Compliance, Global Supply Chain, Global Distribution & Logistics, Commercialization, Engineering, Operations, Automation, Quality and Validation. Specific expertise in strategy through execution, organization development, service delivery, sourcing and vendor management and delivering multi-million operational cost savings and improvements. Results-driven approach with an outstanding track record of business transformation and delivery. . MANAGEMENT COMPETENCIES

Relationship Building Portfolio Management Sourcing Strategy, Negotiation and Business Process

Talent Management/Mentoring OE/Change Management Organization Design and Development Strategic and Operational Leadership Budget/Vendor Management Product Commercialization Quality Systems Implementations Continuous Improvement minds / Risk Management

Cost benefit Analysis/ Vendor

Management

TECHNICAL COMPETENCIES

Program Management/PMP Six Sigma Green Belt Certification / Operational Excellence

FDA/EMEA/Global

Regulations/Compliance

SDLC and validation 21 CFR Part 11 &

S88/S95 compliance

Participations in compliance, validation

and quality audits

ACT tools/Catalyst trained change agent Automation, Control system and Electronic Batch Reporting

EMPLOYMENT HISTORY

Amgen Inc., Thousand Oaks, California, USA 15,000+ employees Supply Chain Manager, Global Track and Trace/Serialization BPO Q1 2015 – Current BPO – Global Business Process Owner for Amgen’s Track and Trace program that includes complying with the global product serialization and track/trace authentication regulations and to enhance anti-counterfeiting and recall capability for Amgen’s commercial drug products. This requires unprecedented level of integration across production and distribution information systems. The intent is to enable manufacturing, distribution, and supply chain tracking of serialized products per existing and emerging regulations which also includes monitoring the changing regulations per country and ensure Amgen effectively adapts and complies. Accountable for the strategy, performance, and continuous improvement of business processes associated with Amgen's Serialization and Traceability processes. Lead the area and responsible for the development, governance, and continuous improvement of Serialization and Traceability business processes. I am responsible for the Traceability Solution that will be aligning the business process, technology and regulations with the help of various benchmarking standards (GS1/RX-360/HDMA etc) that includes enabling transmission of product tracking and authentication information in house and contracted external parties as required (i.e. contract manufacturers, 3rd party logistics, customers, regulators) for local and international markets such as NA, EU, Brazil, Argentina, Korea, etc. that ensures an electronic trail to track individual transportable items as they move through their respective supply chain cycle; a system which creates an electronic trail of where our products go from the packaging line all the way to the final retailer. This also involves partnering cross functionally at Amgen with Amgen IS organization, Supply chain sub teams, Master data teams, ERP team and their vendors, solution, various contracts, solution providers, participating actively on various industry pilots, managing all aspects of the traceability area and parts of Serialization area such as GTIN strategy, management, and the tool. I manage compliance with the DQSA Lot level traceability that is in place since Q1 2015 with a success rate of 99% on the ASN transmission errors for all Amgen shipments. This involves technical troubleshooting of the errors, training customer support teams and resolving all the ASN related issues within 24-48 hours response time. Strong ability to work globally, cross-functionally with local/international teams by operating at the strategic as well as operational level. Demonstrated program management skills to deliver business process implementations and business performance analytics Additionally, I am also managing Serialization and Traceability implementation for Amgen’s Contract Manufacturing Organizations (CMO) interface into Amgen. This is a phased program that currently has 5 CMOs in the immediate scope. This includes integration within Amgen internal systems, traceability vendor and the Serialized packaging line at the CMOs at all steps in the life cycle from strategy, requirements gathering, and data exchange solution go live through onboarding. All Shalaka Khambalkar (MS Engineering Management, PMP, B.S.Engg, Six Sigma Green Belt)

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implementations are complex as they involve planning and managing multiple internal and external cross functional entities and multiple CMO sites that have chosen different local solutions to interface with Amgen interface. Project Manager, Serialization; Operations Project Management Office Q4 2013- Q1 2015

Project managed Amgen’s Track and Trace program by supporting the functional lead by and managed 2 key work streams - Global Traceability and Contract Manufacturing and be the single point of contact from Amgen.

Successfully on boarded all tier 1, 2 and 3 treading partners and established lot level traceability - DQSA compliance by Q1 2015.

Weekly and monthly reporting’s and the governance updates, steering team updates and core team meetings

Coordinated activities with internal and external business partners such as CMOs, Trading Partners, Alliances and Amgen internal teams and escalating issues as necessary.

Project Planning, Creating master plan with interdependencies, resourcing and establishing RASCI, communication plan, monitoring and control to ensure on time and budget deliverables.

Act as a change agent and be flexible as needed.

Perform a gap analysis, identify project risks and maintain risk register and mitigation plans. Support Improving decision making at Amgen by pushing DAI. Strategic Planning and Operations – Operations Performance Excellence Feb 2011– Q4/2013

In this role, I drove multiple initiatives in support of global expansion and planning optimization across corporate, regional and site functions. Implemented S&OP process across Amgen Operations and beyond.

Qualification Improvement Program: Program Manager: Led the design and implementation of Operations and Quality training programs and competency-based curriculums across Amgen sites. Managed this cross functional global program that streamlined the process to qualify manufacturing staff across Amgen globally.

Program Manager: Developed metrics hierarchy cascade from strategic measures through metrics for each OE pillar – Quality, Economics, Culture, and Supply. Overall alignment with Amgen operations strategy. This involved project scoping, chartering, business case development, project management plan development and maintenance, stakeholder communications, risk management etc.

Project Manager: Extending OE beyond Operations – Worked on Improving the MAC process (Material Approval and Compliance) for Global Commercial Operations. Implemented OE tools and methodologies on MAC process to find opportunities to improve Amgen MAC by Interfacing with key stakeholders such as Marketing, Legal, Regulatory, Medical Communications, and Material Compliance.

Program Manager: Knowledge Management Marketplace Redesign- Amgen OIS redesigned KMM tool with SharePoint 2010. Successfully delivered phase 1 of this project as an Operations PM working closely with Operations IS and Business lead to deliver the aggressive timelines.

Participated in a series of sessions that improved commercialization excellence business process (CMCX) to align with alliance management and emerging markets. This initiative improved the overall product commercialization timeline by 40% and involved working end to end with pre-clinical, clinical and commercial cross functional teams to create and streamline current business processes.

Imbibed project management in Excellence in Operations awards program and supported Amgen’s Continuous Improvement mindset cultural change program for Amgen Operations.

Performed analysis for Supply Plan Adherence Metric supporting the Supply Stability initiative within Amgen Supply Chain. Presented a report out to the senior management with recommendations to improve the supply stability.

Managed Neupogen/Neulasta E2E Cycle time reduction program provided a monthly report out that included improvement trends, Pareto analysis and key performance metrics. Designed and managed EPPM portfolios for Neupogen Neulasta initiatives at AML.

Continuous Improvement (OE) tools and techniques such as ACT (Accelerated Change toolkit), SIPOC, VSM, Catalyst, and Six Boxes methodology, Six Sigma toolkit that includes Pareto, P-chart, and control charts using Minitab, several project management tools and routine A3s business cases, EPPM and automated dashboards, metrics reporting Shalaka Khambalkar (MS Engineering Management, PMP, B.S.Engg, Six Sigma Green Belt)

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Project Manager- Supply Chain 2006 - 2011

Project management supply chain management processes [packaging, warehousing, global distribution, planning and forecasting].

Led Global Insulated Shipping Containers Qualification Program that streamlined Amgen’s Global Cold Chain Management Strategy to align both NA and ICO regions. I was the program manager ensuring the on-time and quality deliverables at every stage of qualifications – Physical, Thermal, and Verification and Implementation with support from Amgen cross functional team and the third party suppliers.

Established operational leadership to supported teams and identified cross-functional implications, risks and issues, Elevated issues and work to overcome obstacles, Managed all aspects of projects/processes: planning, estimating, sequencing and scheduling, monitoring and controlling, risk management, execution, and closing, Maintained a master project plan and schedule for assigned projects.

Established and led a cross-functional team from Global Distribution, Corporate Transportation, Supply Chain Planning, Global sourcing, Finance, and external partners to translated plans into actionable and measurable tasks and delivered project standards for quality and quantity, resource modeling. Presented long-term potential benefits to executive management.

Managed cold chain initiative such as global implementation for the Sensitech’s Cold stream software upgrade, Heavy Weight Air Program and Dry Ice refrigerant management for Global distribution. Business Process Management- Transport Validation

Was responsible for implementing transport validation business process in alignment with commercialization excellence

(CMCX) guidance a phased gate approach Amgen used at the time. This involved Product lifecycle planning, executions and implementation of the TV program and adherence to regulations and on time regulatory filings for the product launch.

Led the program through strategy developments, project scoping, charting, planning, metrics development and reporting, and operations compliance to standard policies and procedures in addition to facilitating the execution of the business process by ensuring product commercialization milestones by active participation in Drug product development team, supply chain teams.

Adherence to CMCX processes, owning and authoring master plans, creating business process templates, authoring regulatory filing CMC sections, participating in audits, Authoring New Product Introduction (NPI) section while continuously monitoring, revising, and communicating progress and the business process.

Served as subject matter expert on business process policies and operating standards, working objectively to analyze compliance issues or concerns.

Partnered with cross functional teams and all stakeholders to ensure policies can be operationalized. Researched new methods and standards Cold Chain engineering, FDA regulations and industry developments affecting the development and commercialization of pharmaceutical/biotechnology products, and interpreting their impact on our business practices and policies.

Baxter Healthcare - Bioscience, Los Angeles, CA 45,000+ employees Principal Automation Engineer – Automation Engineering and Validation 2002 – 2006

Responsible for automation engineering and computerized system validation for the LA Fractionation Complex at Baxter Bioscience. Led various functions like - Devise SDLC approach, Distributed Control System and Electronic Batch Records systems configurations, and validations. Participated in Factory Acceptance Testing, Installation/Operational commissioning.

Managed the DCS/EBR validation effort including planning, field execution, monitoring performance and cross functional communication. Led development of Traceability Matrix and system level/Stress Level testing closeouts.

Oversaw a crew of contractors, Generation, Approval and Technical review of all User Requirements, Design Specifications, Functional Specifications, and testing validation documents like Installation/Operational Qualifications and Commissioning test plans including simulation and Field Executions for the System.

Developed and Implemented of Quality Systems and Engineering Polices such as: Quality Change Control Process, Business practices and SOPs for automation -DeltaV, PLC, and Electronic Batch Reporting System (EBRS) life cycle development. System management, Commissioning and Validation Policies for EBRS, user and security management, disaster recovery and data backup, implementation and download procedure and several other procedures per 21 CFR part 11 guidelines, Risk Analysis of product and process using FMEA, HaZOP tools and guidelines.

Put together the system validation package for FDA submission. Set up deviation handling process in accordance with the Plant Change control procedures. Technically reviewed and authored final reports with successful closeouts and deviation Shalaka Khambalkar (MS Engineering Management, PMP, B.S.Engg, Six Sigma Green Belt)

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handling. Resolved Conflict by Identifying critical Path activities and collaborated with different internal departments like Manufacturing, Quality and Engineering and resolve issues and propose time effective solutions to enhance the schedule. Emerson Process Management 50,000+ employees

Senior Systems Engineer, Austin Texas 2000 – 2002

Clients: Biogen Idec, Wyeth Pharmaceuticals, Baxter Healthcare, Bayer MID and Bayer Chlor, Eka Chemicals & Hercules industries, Basf Toyo, ICI-Synetix, and Abbott Industries.

Developed engineering solutions and practices to support Manufacturing, Automation Systems such as DeltaV, PLC, EBR, MES and BAS systems. Core responsibilities include management of Project Engineering team, Manufacturing, Operations Support team and Infrastructure Management team.

Several years of hands-on experience in commissioning, qualification and facility start-up with cross functional teams. Responsible for providing coaching, motivation, development, reorganization and mentoring the junior staff.

Made technology decisions ensuring long-term success of implementation. Developed strategies & processes to ensure cross-functional teamwork & communication.

Systems Engineer, India 1999-2000

Systems Level Testing: As a part of the Technical Engineering Group for Systems design, was involved in the testing of GUI. I was the project member in the database management and testing GUI's. I was involved in the design, implementation and testing of software projects. Led projects in database management and GUIs. Testing,

Projects Undertaken: DeltaV 6.0, DeltaV 6.3: System level testing for batch process and FieldBus devices and signal processors. Prepared the validation test protocols for Tsunami version and executed validation procedures.

ROS 4.0 Testing: Work involved testing functionality and monitoring performance, recommends Solutions for boosting the system performance. OWP 2.2 Tester: A prime tester for the advanced system release using Sybase platform. Written and executed Test Protocols for OWP2.2. EDUCATION & CERTIFICATIONS

Lean Six Sigma Green Belt, Baxter Bioscience and Amgen refresher training. Current

Project Management Professional certified by Project Management Institute Current

Master of Engineering Management, California State University, Northridge 2003-2006

Bachelor of Instrumentation and Control Engineering, Cummins College of Engineering, India 1994-1998



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