Scott Straight Email and Phone Number

Lead internal and contract manufacturing technical activities and projects within Manufacturing Operations in support of Branded Pharmaceuticals commercial production, process development, and new product introduction• Conduct / lead process & product transfers, scale-ups and performance qualifications at contract manufacturing yielding sterile products (solid, liquid, lyophilized), medical devices, and convenience kits• Lead / participate in vendor identification, bidding, and selection processes• Author technology transfer documents including: requests for proposal, scopes of work, validation documents, protocols, reports, batch records, specifications, SOPs, etc.• Serve as the primary technical liaison with contract manufacturers and raw material / component suppliers• Author / review manufacturing and process development sections of CMC submission documents for NDA / BLA • Lead cross functional project teams to ensure scalable and commercial viable manufacturing processes and manufacturability of new products as they advance through process development, scale-up, technology transfer, validation, and commercialization• Provide technical support for critical issues such as manufacturing & laboratory investigations, supplier quality problems, and manufacturing process troubleshooting for lyophilized, liquid, solid dosage, and devices• Lead UDI implementation and GUDID data collection / entry for medical devices and convenience kits• Interface with GMDN Agency to generate new GMDN Terms required for GUDID data submission• Identify areas for process improvements, process efficiencies, and product yield improvements• Organize and lead periodic project updates and progress reporting on strategically important projects / activities• Author, review and approve quality systems and technical documentation required for project execution

Lead External Oversight and Technical groups in the manufacture of biologics, pharmaceuticals, and devices in the United States, Canada, and Germany• Reviewed and approved technical / validation documents, specifications, SOPs, deviations and CAPAs, and change controls• Served as Technical Services external manufacturing representative on Quality Board and Site Leadership Team• Drafted and reviewed global regulatory submissions • Managed technology transfer and new product launch activities• Lead activities related to formulation and process optimization• Reviewed product trend reports and annual product reviews (APR)• Participated in contract manufacturer and vendor audits

Provide QA support for Biologic API manufacture and external manufacturing fill/finish (F/F) operations

Provide cGMP, QA oversight for Johnson & Johnson cold chain Fill / Finish (F/F) contract operations in a high-paced environment, primarily relating to development of two biologics in pre-filled syringes for global markets.

Yes, took a challenge and learned a lot in my journey as the lead resource for pipeline management, marketing, and specialty lending programs for a team of eight Loan Officers

Evaluated and trended quality complaints supporting over 300 global products in all dosage forms

Performed Quality Control activities for liquid and semi-solid products and raw materials