Supply Chain Contract Manufacturing Program Management

MONIKA GUPTA, MBA, PMP, B.S/B.TECH

Milpitas, CA *5035 480-***-**** **.***********@*****.*** LinkedIn GLOBAL SUPPLY CHAIN LEADER

Supply Chain Operations leader with 20+ years of expertise in BioPharma Product Lifecycle Management, Launch Readiness, Contract Manufacturing, Strategic Planning, Operations Finance, and Business Analytics. A trusted partner in driving strategic initiatives, leading high-performing teams, and managing vendor relationships to achieve organizational goals. Skilled in navigating deadline-driven and ambiguous environments with ownership and accountability. Adept at analyzing quantitative and qualitative data, building compelling business cases for executive stakeholders, and fostering collaboration across all levels of an organization. Known for inspiring teams, driving operational excellence, and delivering impactful results. Select Accomplishments

• AGC Biologics – Designed and implemented an organizational structure for the logistics team, established site-specific supply chain KPIs, and developed a high-performing, cohesive supply chain leadership team resulting in 100% On-Time In-Full (OTIF) to manufacturing and site leadership visibility to underlying causes of abnormal scrap.

• Zosano Pharma – Established a Material Review Board (MRB) to streamline decision-making processes and developed a comprehensive scrap process to enhance material accountability and cost efficiency resulting in clean-up of phantom inventory and reduction in scrap in system.

• Boehringer Ingelheim – Directed product launch preparation, execution, and lifecycle management, ensuring strategic alignment with sustainability and profitability goals resulting in successful FDA approval and launch of first commercial product at site and increased trust with client.

• Impax Laboratories – Managed a spend of ~$30M for external manufacturing relationships with up to 25+ companies. Managed evaluation and selection of contract manufacturers, planning and coordination of product transfers within or to contract sites. Improved Supply Agreements compliance from 70% to 100%.

• Amgen – Achieved savings of $150,000+ by proposing and implementing a re-modeled vendor’s invoicing structure. Led operational excellence projects resulting in statistical tools for safety stocks, reorder levels and pull-based planning. CORE STRENGTHS & COMPETENCIES

Contract Manufacturing Management

Demand Forecasting & Planning

Supplier Relationship Management

ERP Systems Integration

Project Management

People Management

Financial/Cost-Benefit Analysis

Budget Management

Supply Chain Planning, S&OP

SAP, QAD, Microsoft AX

Kinaxis RapidResponse

Procurement & Sourcing

PROFESSIONAL EXPERIENCE

AGC Biologics Bothell, WA

BioPharma Drug Development & Mfg Revenue ~$600M Employees: 2500+ Sr. Director- Supply Chain 2023 - 2024

Served as Site Supply Chain Head and integral member of the Site Leadership Team, leading planning, procurement, and warehouse operations at a cGMP Biologics manufacturing facility, ensuring uninterrupted supply of GMP products for clinical trials and approved commercial markets.

Instituted organization structure for logistics team, quarterly all-staff, daily stand-ups and developed high performing, cohesive site supply chain leadership team.

Designed Site Supply Chain metrics to measure performance of inventory financials, planning, procurement and warehouse and shared KPI trends with staff.

Streamlined end-to-end supply chain processes, reducing lead times and improving material availability to support production targets and regulatory compliance.

Partnered with global stakeholders to drive supply chain excellence, aligning site operations with corporate objectives and contributing to operational efficiencies and cost savings. Zosano Pharma Fremont, CA

Pharmaceutical Drug Development & Mfg Revenue ~$1M Employees: 50+ Director- Supply Chain and Contract Manufacturing 2021 - 2022

Directed supply chain operations, including planning, purchasing, and warehouse activities, to ensure effective inventory management, accurate forecasting, and seamless logistics for meeting commercial production demand and handling returns/disposal of clinical trial materials.

Established a Material Review Board (MRB) to streamline decision-making processes and developed a comprehensive scrap process to enhance material accountability and cost efficiency.

Designed a QAD (ERP system) improvement roadmap, optimizing system functionality to improve operational accuracy and supply chain visibility.

Managed external contract manufacturers to improve delivery timelines and production costs, ensuring alignment with organizational goals and project requirements.

Boehringer Ingelheim Fremont, CA

BioPharma Drug Development & Manufacturing Revenue: ~$20B Employees: 50,000+ Associate Director- Supply Chain Planning and Systems 2020 - 2021

Led supply chain business analysis team overseeing the SAP audit, design/improvement in SAP planning processes including Bill of Materials compliance between process engineering, manufacturing and procurement systems and led kick-off preparation for S/4HANA upgrade.

Mentored and trained SAP end-users across process engineering, manufacturing, quality, logistics, and planning, enhancing operational efficiency.

Associate Director- Biopharma Product Management Operations 2018 – 2020

Accountable for overall product ownership by cross-functionally aligning all product relevant topics, leading cross-functional teams, driving cross-functional decision making, communicating product strategy and performance to internal and external stakeholders.

Led cross-functional team for product launch preparation, launch execution and life cycle activities ensuring strategic level product management with focus on sustainability and profitability. Covered all strategic aspects of product: safety, quality, supply chain design, production, risk, regulatory, sourcing & outsourcing, cost and product budget and crisis management. Impax Laboratories Inc. (now part of Amneal Pharmaceuticals) Hayward, CA Industry: Pharmaceutical Manufacturing Employees: 2500+ Senior Manager- External Manufacturing/CMC Project Management 2014 - 2018

Championed the successful launch of a controlled substance product, managing the end-to-end CMC process, including method transfer, demo runs, packaging, and regulatory submissions, ensuring timely approval and market entry.

Trusted partner in executing strategic confidential initiatives at organization. Managed Impax contract manufacturing sites through executing activities as per company’s business policies.

Orchestrated cross-functional collaboration across teams (Technical, Quality, Supply Chain, Regulatory, Legal, Finance), ensuring adherence to product quality, cost control, and on-time delivery from contract manufacturing sites.

Crafted detailed Request for Proposals (RFP) to clearly document Impax expectations around compliance, quality, and production standards. Managed the selection and evaluation of contract manufacturers.

Developed tools for managing contracts lifecycle improving Supply Agreements compliance from 70% to 100%.

Managed capital and project budget monitoring and reporting; ensured cost of production targets are met; and actively managed projects, forecasting and production planning.

Developed and managed KPI to measure, track performance of CMOs/CPOs, and report to external or internal operating review meetings.

Served as SME in routine leadership briefings, facilitating informed decision-making on strategic and confidential initiatives.

Provided coaching and feedback for recruitment and development of staff, fostering growth and driving team success. Amgen Inc. Thousand Oaks, CA

Industry: Biotech Revenue: ~$25B Employees: 10,000+ Supply Chain Manager- Contract Manufacturing 2011 - 2014

Represented Amgen at external vendor meetings and served as a subject matter expert for clinical (Phase I–III) and commercial products on global supply chain teams.

Achieved $150,000+ in savings through redesigning and implementing a vendor invoicing structure.

Ensured flawless shipping performance metrics, meeting tech-transfer requirements, and FDA filing deadlines.

Conducted detailed analyses of persistent supply chain challenges, resolving issues related to source allocation models, yield calculations, and SAP (ECC) product design.

Designed responsive supply impact models to support agile manufacturing decision-making.

Conducted assessments of contract manufacturing supply chain processes, optimizing SOPs and business practices. Project Manager- Corporate & Strategic Resource Planning 2007 – 2011

Established and led cross-functional teams from Corporate Planning, Finance, Cost Accounting, Business Performance, and external partners to develop financial reporting capabilities in Kinaxis RapidResponse integrated with SAP data.

Devised consumption-based pull methodology to reduce scrap costs, presenting benefits to executive management.

Facilitated value stream mapping (VSM) workshops to optimize the invoicing process for contract manufacturing, reducing past-due invoices by 85% over six months.

Streamlined analytics for Finance and Contract Managers, creating a unified information source for Quality.

Developed a monthly Inventory Management Review Board process to monitor operational cross-functional metrics.

Created SCOR-based frameworks and commercial supply chain performance metrics for a Supply Chain Dashboard portal, sparking executive discussions with external vendors.

Implemented statistical models to establish safety stocks and reorder levels, collaborating with McKinsey as part of Operational Excellence. Trained planners on the new business processes.

Deployed Kinaxis RapidResponse integrated with SAP APO, liaising with Business, IS, and vendors to optimize supply chain. ADDITIONAL EXPERIENCE

MBA Intern-Integrated Supply Chain, Whirlpool Corporation, Benton Harbor, MI Technology Practice Lead, Intrasphere Technologies (Now Part of Deloitte), Gurgaon, India Business Intelligence SME/ Sr. Software Engineer, CMC Ltd. (Now Part of TATA Consultancy Services), India & USA EDUCATION & PROFESSIONAL DEVELOPMENT

W. P. Carey School of Business at Arizona State University, Tempe, Arizona Master of Business Administration, Supply Chain Management and Financial Management and Markets School of Engineering & Technology at Jamia Millia Islamia University, New Delhi, India Bachelor of Technology (B.S.), Electronics & Communications Engineering CERTIFICATIONS:

Clinical Supply Chain Management certified by Georgia Clinical & Translational Science Alliance, Aug 2024 LEAD – Women Unlimited Inc., May 2020

Lean Six Sigma – Villanova University, May 2011

Project Management Professional certified by Project Management Institute, Aug 2009 W. P. Carey School of Business at Arizona State University, Tempe, AZ, Aug 2005 – May 2007 PROFESSIONAL AFFILIATIONS

Member: Association for Operations Management (APICS), 2008-Present Officer: Toastmasters International, 2007-2008

Officer: W. P. Carey MBA Supply Chain Management Association, 2005-2007 Officer: W. P. Carey chapter of the National Association of Women MBAs (formerly GWiB), 2005-2007 Member: Institute for Supply Management & Council of Supply Chain Management Professionals, 2005-2018 COMMUNITY INVOLVEMENT / VOLUNTEER EXPERIENCE

Teacher: Art of Living for Meditation, Mindfulness and Yoga, 2014-Present Teacher: Chhandam School of Kathak “yoga”(Indian classical dance art form), 2011-2018 Community Service Chair: Amgen Indian Sub-Continent Network, 2007-2009 Volunteer: Habitat for Humanity, 2007-2014

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