James Holloway Email & Phone Number

Lake Zurich, Illinois, Us

Respected business leader with vast experience driving product development, manufacturing, quality, CMC, and supply chain from the pre-concept stage through commercialization and post-market analysis within the pharmaceutical, biopharmaceutical, and medical device industries. Background encompasses technical product development, scale-up, commercialization, technology transfer and cmc management of drugs, biologics, antibiotics, vaccines, and Schedule 2 and 3 DEA controlled substances. A forward-looking strategist that incorporates in-depth understanding of Technical Operations and Supply Chain global operations to build efficiencies and process harmonization, while effectively driving product portfolio delivery, resulting in higher-level predictability to top-line and bottom-line forecast.

Pharmaceutical and Medical Device Portfolio/Program/Project Management Consulting. Driving program management best practices and business process development from ideation through successful product commercialization. Creating value for companies through technical product development, scale-up, commercialization, and technology transfer of drugs, biologics, antibiotics, vaccines, sterile injectables, and schedule 2 DEA controlled substances.

Franklin Lakes, New Jersey, Us

BD Medical (Formerly CareFusion – Procedural Solutions Segment)Vernon Hills, IL 2011 – 2018Director, Program Management & GPDS – R&D EngineeringLeading healthcare provider with three major business segments: Medical, Life Sciences, and Interventional product lines. Initially hired to establish R&D PMO, driving predictability and competency of portfolio delivery for the Infection Prevention franchise and promoted within first year to set up a R&D portfolio and PMO for the Procedural Solutions business segment with five franchises in consumable medical devices. Role expanded to nine franchises in 2015 when CareFusion was acquired, with direct accountability for leadership, integration, and expansion of the outsourced engineering operations in India. Led R&D Program Management group for the multibillion-dollar BD Medication and Procedural Solutions Business. Managed budgets, four direct reports, 61 BD Program and Project Managers, and 300+ outsourced R&D Engineer Associates. Contributions: Grew first-year revenue by $50M and $20M+ in subsequent years by expanding ChloraPrep into 15 European markets. Captured ~85% on-time delivery. Implemented Product Lifecycle Management software tool in support of Program Management across the enterprise. Expanded network bandwidth, at the BD India Development Center and grew facility to ~350 associates, four labs, and four product aging chambers. Captured an $11.3M savings by identifying synergies in the integration of CareFusion R&D with the new BD R&D organization.

Ingelheim Am Rhein, Rhineland-Palatinate, De

Boehringer Ingelheim Vetmedica, Inc. (Division of Boehringer Ingelheim)Fort Dodge, IA 2009 – 2010Director, Project Management Office – US ManufacturingFollowing the largest divestiture at the time, Vetmedica, as the animal health segment within Boehringer Ingelheim, was expanded via the acquisition of over 250 animal health products from Pfizer, Inc.Selected as the post-acquisition Manufacturing Team Leader for transfer of 200 products as part of the largest divestiture of pharmaceuticals and biopharmaceuticals in U.S. Federal Trade Commission’s history at the time. Provided tactical leadership and training to PMO and project leadership in the Boehringer Ingelheim Vetmedica, Inc. organization. Oversaw team of 48, department budget and annual capital project budget for product transfers. Contributions: Managed product acquisition, site transfers (Pfizer, Inc. to Boehringer Ingelheim) and regulatory approvals. Completed product transfers within nine months and under budget by ~$5M, vastly surpassing original target completion of three year.

Building 32, Suite 400, Overland Park, Kansas, Us

Pfizer Animal Health (Formerly Fort Dodge Animal Health, a division of Wyeth)Fort Dodge, IA 2008 – 2009Director, Project Management Office – US Manufacturing Former $1.3B division of Wyeth, manufacturing over 250 drugs and vaccines for the treatment of animals and humans. Established and led PMO for the Animal Health Division with 48 team members and capital budget across the enterprise. Developed and directed portfolio of 97 strategic projects across three manufacturing sites. Provided program management support to the Operations team leaders, functional leaders, and the U.S. Manufacturing Committee (Governance Board/Steering Committee). Within three months after FDAH’s announcement of an acquisition by Pfizer, Inc., scope expanded to identification and implementation of pre-acquisition cost savings. Contributions: Launched the PMO within three months across five manufacturing sites while reducing manufacturing backorder volume from $12M to $0. Drove US manufacturing leadership to achieve targeted annual revenue of $850M in nine months vs 12 months. Captured 20% reduction in forecasted budget.

Somerset, Nj, Us

Catalent Pharma Solutions (Formerly Cardinal Health, PTS)Raleigh, NC 2007 – 2009Director, Project Management & Global Contract ServicesFollowing divestiture of Cardinal Health’s Pharmaceuticals and Technology Services division, the division was renamed Catalent Pharma Solutions, providing drug delivery technology and development solutions for drugs, biologics and consumer health products. Expanded leadership role to encompass both PMO and the Global Contract Services group for the North American manufacturing, laboratory, and packaging sites, following Catalent’s acquisition of the PTS division. Directed seven direct reports and budgets. Achieved $25M revenue target, including $10.5M of new incremental revenue.

Dublin, Oh, Us

Cardinal Health, Pharmaceuticals & Technology Services (PTS) Raleigh, NC 2005 – 2007Senior Project Manager – Cardinal Health, PTSPromoted to direct the Manufacturing PMO and team and budgets in construction and operation of a new sterile injection product manufacturing facility. Liaised with Business Development and Bids/Contracts for client presentations, development of proposals and Clinical and Commercial Product Supply Agreements, and creation of pricing for technology transfer, development, clinical trial, commercial manufacturing, and regulatory support. Spearheaded sterile injectable facility design (installation, qualification, and validation of manufacturing equipment, clean room suite qualifications, personnel flows, and material flows). Led first sterile injectable product to commercial approval by ensuring that facility design and processes met the requirements for a multi-product production facility. Generated several million dollars in new incremental annual revenue.

Dublin, Oh, Us

Cardinal Health, Pharmaceuticals & Technology Services (PTS) Raleigh, NC 2004 – 2005Project Manager – Cardinal Health, PTS Oversaw project management portfolio at the Raleigh site. Co-wrote and advised on project management practices/policies across 30 global sites as member of the Corporate Steering Committee on Project Management. Oversaw successful FDA site registration and approval for a multi-product sterile injectable contract manufacturing facility. Directed initiative which led to commercial product approval from the FDA Center for Biological Evaluation and Research (CBER).

DSM Pharmaceuticals Inc.Greenville, NC 2002 – 2004Senior Development ScientistPharmaceutical manufacturer of sterile injectables, orals, topicals, dose form manufacturing, scheduled drugs, clinical manufacturing, fill finish, aseptic filling, terminal sterilization, and cold storage. Promoted from Development Scientist III (2001 – 2002) and Development Scientist II (2000 – 2001) to lead development of multiple sterile injectable technical transfer products from clinical Phase II to commercial products, ranging from monoclonal antibodies, small molecules, DEA Class 2 controlled substances, and semi-synthetic antibiotics.

New York, New York, Us

Prior positions: Senior Development Scientist for Process Research & Development at Pharmacia & Upjohn Inc.Senior Development Scientist for Process Research & Development at Pharmacia Hepar, Inc.Development Scientist for Process Research & Development at Pharmacia Hepar, Inc.

M.S., Chemistry (Organic Synthesis)

B.S., Chemistry (Organic)