Robert Mcclay, Pmp Email & Phone Number

New York, New York, US

• Developing innovative assets from API and drug product development to commercial launch, engaging with R&D, Commercial, Regulatory, Finance, Tax, Supply Chain, regulatory agencies and internal and external.
• Paxlovid (nirmatrelvir/ritonavir) -- Demonstrated and proven leadership for co-development and governance processes to drive expedited formulation development, tech transfer and supply chain development, ensuring.

New York, New York, US

Representing Pfizer Global Manufacturing, lead evaluations of business development opportunities for Pfizer’s worldwide biopharmaceutical businesses by providing leadership and coordinating due diligence teams. Work closely with business units and manufacturing leadership in formulating strategies and seeking endorsement for business development.

New York, New York, US

• Lead team to industrialize new pharmaceutical products, providing product knowledge and expertise on process capability, manufacturing and asset maximization to accelerate global commercialization of new products from.
• Lead new oncology product teams to develop and execute plans for technology transfer, registration batch manufacturing, process validation, and global commercial launch. Project scope includes $10-20 million budget.
• Received 2008 President’s Achieving Excellence Award for finalizing commercial formulation and process at the commercial manufacturing site prior to initiating Phase 3 studies, reducing costs and regulatory risks.
• Conducted sourcing exercises by selecting a commercial manufacturing site, based on quality and GMP requirements, capacity and demand analyses, and projected cost of goods.
• Reduced cost of goods by incorporating lean concepts, including process analytical technology, to ensure manufacturability and cost-effective.
• Determined product and package trade dress, minimizing SKUs and standardizing formats to reduce global costs.

US

• Managed the scientific collaboration for research and development of the company’s product candidates. Lead efforts to analyze current project operations and make recommendations for improvement and coordinate the.
• Coordinated activities between Clinical Research, Data Management, Pre-clinical Development, CMC Development, Quality Assurance, and Regulatory Affairs to evaluate the effect of an intravenous, anti-angiogenic compound.
• Managed team to prepare a strategy and to meet with FDA for a Pre-IND meeting, resulting in a mutual agreement between the Agency and the company on a Phase 2/3 clinical program. Published comprehensive IND and met.
• Co-led a CRO selection team to identify and select a global CRO to manage the Phase 3 clinical development of the candidate product. Facilitated efforts to finalized contracting and budgeting/cash flow. Led, supported.

Rahway, New Jersey, US

• Provided program management for resource modeling and formulation development. Responsible for aligning organization with Clinical Research and company objectives by developing strategies, plans, and timelines which.
• Defined global models to predict resource requirements and understand the organization’s capabilities and capacities to meet the forecasted clinical demand. Provided strategies and direction for teams to meet demand.
• Facilitated new product development activities with team members from Pharmaceutical Chemistry, Formulation Design, Analytical Development, and Clinical Supply Operations. Defined and managed global clinical supply.
• Defined timelines and milestones to track development projects, communicate status, and provide options to mitigate risks.

Cambridge, Cambridgeshire, GB

Managed Product Industrialization’s Gastrointestinal (GI) Business Unit, by providing technical and administrative leadership. Coordinated and managed all pre-commercial technical development activities, including formulation development and manufacturing technology transfer, for new chemical entities and line extensions for AstraZeneca's GI product.

Rahway, New Jersey, US

• Implemented Merck's global facility plan and strategic initiatives for the manufacturing division within Europe. Participated on teams to develop manufacturing "Centers of Excellence".
• Provided leadership for $40 million Italian plant expansion project (10,000 square meter expansion and 12,000 square meter renovation).
• Actively involved on cross-functional teams in determining plant technical capabilities and manufacturing/packaging capacities.
• Modified plant focus to concentrate on solid dosage manufacturing flexibility to efficiently serve many markets.
• Design provided sufficient space, infrastructure, and capacity to accommodate future volume growth and new product introductions.

Rahway, New Jersey, US

• Designed production processes and performed new parenteral product scale-up worldwide.
• Developed the manufacturing process for a new class of anti-glaucoma agents in the United States, Italy, France, and Japan. Contributed to the regulatory approval process worldwide. Met launch dates in North America.
• Developed the manufacturing process in Japan for a new sterile injectable for treatment of osteoporosis.

Rahway, New Jersey, US

Documentation and on-line quality monitoring for solid oral dosage manufacturing and packaging.

Bs, Bioengineering

Education record