Doug Daniels Email & Phone Number

Chapel Hill, NC, US

Cary, North Carolina, United States

Analytical Leadership- Oversee analytical method development & phase appropriate validation along with method transfer for biologic drug substance and drug product.- Provide scientific and technical leadership to internal and external teams.- Manage budgets for analytical activities.Clinical Support- Manage CROs to provide project oversight for.

RTP, NC

- Provided scientific and technical leadership to internal and external teams.- Oversaw analytical method development & phase appropriate validation along with method transfer for drug substance and drug product.- Reviewed and interpreted analytical results. Provided technical input into deviations and atypical results to ensure appropriate investigations.

Raleigh-Durham, North Carolina Area

• Managed team of 12 responsible for analytical methods lifecycle (development, validation and transfer) in QC laboratory value streams (Metered Dose Inhalers, Dry Powder Inhalers, Oral Solid Dose, Incoming Raw Material.
• Managed team of 12 responsible for analytical systems implementation in QC laboratory value streams.
• Subject matter expert for analytical equipment, analytical methods, laboratory investigations (RCA and CAPA's) and drug product stability.
• Analytical lead for new product introduction (NPI) for the Zebulon site. One new product was delivered per year.
• Delivered ICH Q3D remediation of the Zebulon site. Sixty drug product reports were delivered in order to meet FDA guidelines by Jan, 2018.
• Managed 15 analytical laboratory staff developing and validating methods for stability. Led stability testing for MDI, DPI and OSD drug products.

• Technical lead for computer validation of IT systems in QC laboratory.

Worked for Dr. Dan Norwood in Extractables testing group. Group leader for team performing leachables/extractable testing (GC and GC/MS) for pharmacutical components and finished drug product.

Product Specialist with Fisons Instruments (VG Instruments). Supported MD800, Carlo Erba GC8000 and other single quad mass spectrometers.

Burlington, NC

Forensic Toxicology GC/MS analysis and review (confirmation testing) of drugs of abuse (NIDA). Instrumentation specialist for HP GC/MS systems. Research & Development implementation/transfer of Methylmalonic acidemia testing from Metabolite Laboratories.

Kernersville, NC

Implementation of EPA drinking water methods using Extrel ELQ-400 GC/MS system.

Cary, NC

EPA environmental testing following methods 8240/8260, 8270, 624, 625, 524 and 525.