Robert Ashton Email & Phone Number

Oreland, Pa, Us

Raritan, New Jersey, Us

• Support the production of new and commercial pharmaceutical drugs.• Represent External Supplier Integration (ESI) Quality Assurance North America on new projects, product transfers and product improvement teams by guiding technology transfer decisions, setting project quality/compliance requirements, developing SOP’s and specifications as needed and providing technical transfer/validation support.• On-going management of parental, liquid and solid contract manufacturing locations through cGMP audits, driving compliance and quality improvement initiatives, assisting in the resolution of process/product non-conformance events, monitoring/resolving product complaints and review of Product Quality, reporting Contract Manufacturer performance metrics and conducting management reviews.

Us

The Senior Manager Technical Operations External Manufacturing is the focal point for the technical aspects for all site projects, CAPAs, Investigations in the EM space for all dosage forms: processing and packaging.The role provides technical support for Supply Chain Planning, EM site leaders and EMQA for management of technical issues at external manufacturing partners, both internal J&J (JSC) and external to J&J.It serves as a facilitator for all external manufacturing related projects and issues, is able to conduct technical assessments at external manufacturers and identifies, designs executable strategies and owns corrective action plans to be executed in coordination with the external manufacturers.It involves proactive identification of action plans to improve the sustainability and consistency across the manufacturing network. Accountable for timely execution of management action plans and CAPA's driven by technical issues/ gaps, reviews and approves APRs and has oversight of CPV. It provides technical and scientific input for regular business reviews of existing and due diligence reviews associated with potential external manufacturers and/or expansion of existing external manufacturers.It is a core member of and an active technical/scientific contributor for EMOP's PET and RVPA.

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Quality Account Manager for External Manufacturers of solid and liquid pharmaceutical products.Review and approve validation protocols, cleaning protocols, batch records and non-conformances.

Perform various duties (on-site manufacturing and post manufacturing data mining) to support the transfer of manufacturing operations from clinical manufacturing to commercial scale manufacturing.

Manufacture Phase I and II Clinical Supplies in Building 78 under cGMP conditions.

Horsham, Pa, Us

Primary responsibility is to execute whatever is necessary to meet scheduled delivery dates of pharmaceutical products as requested by PMRS Clients.Responsible for the procurement of raw materials and packaging components used for manufacturing and packaging of tablets, capsules, liquids, and semi-solids. Created and modified over 1000 Manufacturing and Packaging Master Batch Records for review and approval by Clients. Prepare change controls with justifications to improve manufacturing directions of clinical and commercial supplies. Participated in FDA Audits of Manufacturing Facility and Processes in support of 5 New Drug Applications. Developed, authored and performed process validations of manufacturing processes in support of the 5 New Drug Applications.Materials and Production Planning Manager of manufacturing and packaging schedules to meet multiple client timelines for Clinical and Commercial Supplies.Lead formulator in the development, either independent of Client or in conjunction with daily Client process management/involvement, for early clinical supplies and transfer to commercial manufacturing supplies. Led team in the implementation of a Weigh and Dispense Module within the web-based Compliance Suite supplied by Emerson Process Management.Advised as a manufacturing key stakeholder in the design and build out of a new 120,000 sq ft manufacturing facility including 40,000 sq ft of ISO-8 certified space for wet and dry granulations for tablets and semi-solid dosage forms including high potency pharmaceutical products.

Philadelphia , Pennsylvania, Us

Procurement responsibilities for construction and contract services, pilot plant chemicals and MRO supplies (includes lab supplies).Led team in the implementation of the AMEX procurement card to purchase lab supplies and chemicals reducing the total number of purchase orders and invoices.Implementation Team Member for SAP Material Management and Finance Modules for the APG Division of the Specialty Chemical Group. Trainer of SAP Material Management Module for over 500 employees at Princeton, R&D Center.

Us

Responsible for developing, negotiating and implementing long term sourcing strategies and contracts to ensure continuity of suppliers. Worked closely in a team environment with R&D, Plant Operations and Marketing to reduce total cost of products.Visited global sources for aluminum hydroxide, the major ingredient (5 ½ million lbs/yr) in the formulation of Mylanta. Negotiated long term contracts which reduced costs by 25% moving over $1,320,000 to the bottom line.Identified a source of 100% magnesium hydroxide powder which replaced the magnesium hydroxide paste ingredient. The piece price savings combined with lower freight costs reduced the price per pound by 43% which saved over 1,000,000 annually.Received the J&J Achievement Award for cost reduction activities relating to Mylanta production.Developed a national SOP for 200-300 chemical compounds which were used by suppliers to package, drum, bag, etc., all items sent to McNeil. This SOP advised all suppliers of McNeil's requirements and facilitated the elimination of return goods, reducing non-value added activities.; RHONE-POULENC RORER, INC.Rhone-Poulenc Rorer was a manufacturer of pharmaceutical products such as Maalox and Ascripton.

Directed the purchasing of raw materials/chemicals, bottles and caps to support the manufacturing and packaging processes at the Ft. Washington facility.

Managed the planning department activities to produce the packaging schedules to meet sales forecasts.

Responsible for the timely procurement, coordination of testing, and approval of raw materials to meet manufacturing schedules.

Responsible for managing the production of wet, dry, and continuous granulation processes.

Responsible for managing the production of liquid suspensions, creams and ointments.

Responsible for testing raw materials, in process granulations, liquid suspensions and finished packages.