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 bioanalytical/biomarker testing support of clinical phases.- Lead and manage bioanalytical testing support of clinical programs at CROs.Drug Development- Lead analytical development for biologic drug programs (CMC team).- Author analytical technical documents to support regulatory submissions.- Author and review IND, IMPD and BLA CMC analytical modules for submission. - Direct, coordinate and monitor analytical activities at CROs.Commercial Support- Review and interpret analytical results. Provide technical input into deviations, out of specification and atypical results to ensure appropriate investigations and CAPAs.- Author, review and approve analytical quality documents supporting commercial testing.- Provide oversight of stability testing programs including review of protocols along with tracking, trending, and reporting of data.- Serve as subject matter expert for audits of CROs.- Lead for analytical change controls.

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 and CAPAs.- Directed, coordinated and monitored analytical activities at CROs.- Worked with CROs to provide project oversight.- Led and managed analytical support of clinical programs at CROs.- Provided oversight of stability testing programs including review of protocols along with tracking, trending and reporting of data.- Authored analytical technical documents to support regulatory submissions.- Served as subject matter expert for audits of CROs.

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, Microbiology). • 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. • Delivered analytical and stability sections for 3 drug products (US and European submissions). • Analytical lead responsible for a low cost dry powder inhaled formulation.• Led multiple site Lean Six Sigma training program and served as coordinator for six significant projects.

• 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.