Engaging leader with 25+ years of broad cross-functional experience in internal and external pharmaceutical manufacturing. Strong technical and business training and experience. Proven track record of managing successful business transitions and operational improvement initiatives.
Overview
29
29
years of professional experience
Work History
Director & Head Supply Chain
Cipla Therapeutics
Warren, USA
02.2022 - Current
End-to-end manufacturing and supply chain lead, and key member of cross-functional leadership team for branded pharmaceutical division of Cipla
Accountable for all aspects of manufacturing and supply of a commercially distributed specialty product, supply planning for launch of a pipeline of 8 internally developed products, and supply chain and operations due diligence for series of business development assets evaluated for purchase offers
Led cross-functional Virtual Manufacturing Team to ensure timely and compliant planning and execution of all operations, supply, quality, and regulatory activities for a US commercially marketed sterile finished product
Reduced inventory scrap liability associated by negotiating a ~25% reduction of finished good contractual take-or-pay obligations and facilitating activities to extend API and finished good shelf life by 2-3 years
Facilitated supply and operations activities required to receive marketing authorization and import license to launch US commercial product in India, and file same product in South Africa for marketing authorization
Performed operations and supply due diligence activities for 13 asset acquisition targets, and reverse due diligence activities for 1 asset sale
Director External Supply
Zoetis
Florham Park & Parsippany, USA
05.2013 - 02.2022
Led team of up to 12 Operations/Category and Supply Chain Managers, managing a portfolio of up to 46 US-based third-party finished good suppliers, supplying up to 330+ SKUs globally (50+countries), representing up to $110 Million in COGS, and up to $360 Million in annual revenue
Accountable for adherence to financial, customer service, quality, and risk management performance metrics, negotiation of service and supply agreements, third-party drug product sourcing for new or transferred products, and operations representation on transfer and due diligence teams
Implemented routines and proactively addressed supply issues to increase year-on-year customer service levels and reduction in quality high risk suppliers for five consecutive years
Drove cost savings initiatives resulting in 13% (2017) and 6% (2018) budget-to-budget COGS reductions, and actual-to-budget savings of 3% (2015), 5% (2016) & 4% (2017)
Led US External Supply Team through Zoetis separation process and de-centralization of supply chain functions to successfully implement a streamlined customer focused external supply team
Sr. Manager External Supply
Pfizer
Peapack, USA
01.2011 - 05.2013
Led cross-functional Virtual Site Operating Teams (VSOT) to supply products from a portfolio up to 22 US third-party suppliers, representing ~$50 Million in annual spend
Accountable for adherence to customer service, quality, and risk management performance metrics, negotiation of service and supply agreements, third-party drug product sourcing for new or transferred products, operations and supply chain representation on transfer and due diligence teams
Initiated and led independent biological-product focused VSOT for large, low-performing supplier to exceed % In-Stock metric by 24% of 2012 target
Implemented routines and proactively addressed potential supply issues to achieve 100% in-stock, 100% first-time-right, and 100% risk-management, quality, and APR commitment adherence for all suppliers in 2012
Associate Director Engineering & Validation
Wyeth/Pfizer
Pearl River, USA
10.2006 - 01.2011
Managed team of 12 Managers/Engineers (+contract resources), responsible for engineering, qualification, validation, and verification activities to support manufacturing operations to supply a vaccine generating annual revenues of more than $2 Billion
Managed budgeting and project management associated with up to $34 Million of capital funding
Led validation team to perform aseptic media simulation studies to allow implementation of tandem filling campaigns, increasing syringe filling line capacity by 40%
Led qualification and validation activities required for start-up of commercial vial-filling operations, ensuring adherence to compliance, budget and schedule requirements
Ensured timely filing of 'next generation' product as site drug product representative on cross-site validation team responsible for validation harmonization and completion of validation studies and associated filing documents
Implemented process to integrate responsibility for equipment qualification (IQ, OQ, PQ) activities and expertise into existing Project Engineering roles
Led team to utilize Lean Six Sigma and Operational Excellence concepts and tools to streamline equipment life cycle through implementation of a Risk Based, Quality by Design, ASTM E2500 Verification approach
Associate Director Biotech Manufacturing Operations
Wyeth
Pearl River, USA
08.2002 - 10.2006
Led a three-shift aseptic filling operation staffed by 14 Managers/Supervisors and 98 bargaining unit operators, and a fermentation and purification operation staffed by 12 Managers/Supervisors and 32 bargaining unit operators responsible for fermentation, purification, and associated support operations
Accountable for supply of a conjugated pneumococcal vaccine with annual sales revenue of more than $2 Billion
Maintained workforce morale and facilitated technical and operational solutions during workforce downsizing and transition from vial filling to a syringe filling operation, allowing for an un-interrupted supply of vaccine to the market
Fostered a culture QA collaboration, sponsored enhance batch record usability initiative, and implemented communication tools to reduce release cycle time by 75% and batch record errors by 80% (Q2 2005 versus 2003)
Implemented critical utility usage management and alternate operations shifts to offset peak utility usage activities, allowing for a 100% increase in drug substance production capacity to meet commercial and clinical demands
Manager, Material Supply
Wyeth
09.2001 - 08.2002
Managed a team of 9 supervisors/clerical assistants and 41 bargaining unit truck/trailer drivers and warehouse workers responsible for receipt, handling, tracking, and delivery of 250 pallets and 335 small packages per day, and storage, tracking and maintenance of 7,500 pallets of production material to support pharmaceutical, vaccines, and consumer health products manufacturing and research organizations
Developed and implemented operational procedures to meet requirements of Consent Decree commitments to ensure an efficient, compliant material supply operation
Manager, Technical Operations
Wyeth
11.2000 - 09.2001
Led a technical support team of 7 project engineers & managers responsible for providing technical/logistical support and equipment life cycle management to a 24 hour - 7 day consumer health product manufacturing operation
Developed cost/capacity model recommendations for labor/equipment resourcing, expense/capital budgeting, and product outsourcing recommendations
Developed a 5-year, $200 Million dollar capital budget plan to maintain the manufacturing operation at the required level of capacity, efficiency, and regulatory compliance
Managed a $10.6 Million capacity expansion to increase production capacity from 6.4 to 9.9 Billion tablets annually