Alex Marsh Email & Phone Number

Chapel Hill, Nc, Us

London, Uk, Gb

Inhalation product development for DPI, MDI, intranasal and nebulised formulations for novel small molecule respiratory therapies. Design, develop and validate drug product formulation, manufacturing process and analytical characterisation methods from feasibility through clinical and commercial.DPI, MDI, intranasal and Nebulised manufactured product, process and equipment design and development, scale-up and technical transfer. Establish and lead pilot-scale, clinical and commercial manufacturing and quality control operations at multiple global CDMO sites.Lead product development programmes ensuring delivery of essential project milestones for development, regulatory filing and launch: Clinical trials planning, manufacture and supply; IND-enabling batch manufacture and characterisation; Toxicology/safety study planning, test article preparation and supply; development program history data compilation, evaluation and analysis, report authoring.Compile NDA and IND CMC sections of regulatory dossiers for FDA and International Regulatory Authority approval, respond to Regulatory Authority Information Requests, Prepare Post-Approval regulatory submissions.

Watertown, Massachusetts, Us

•Development and implementation of wet-dry autoinjector drug-device combination product formulation filling manufacturing process, technical transfer, qualification, validation, industrialization for commercial•Development of drug formulation for a wet-dry autoinjector drug-device combination product•Development and implementation of drug substance particle engineering process suitable for a wet-dry autoinjector, qualification, validation, industrialization for commercial•Development and implementation of drug substance and drug product QC analytical and QC microbiological/sterility testing methods, technical transfer, qualification, validation, readiness and specification development for commercial for a wet-dry autoinjector•Establish drug formulation filling and visual inspection manufacturing process operations at commercial site(s) for a wet-dry autoinjector and ensure facilities and operations in compliance with relevant regulations•Devise end-to-end contamination control/minimisation strategy for drug product production process and material inputs, facility, material movement, personnel etc•Prepare GMP documentation for process operations - batch records, work instructions, procedures, methods, qualification scripts, protocols, reports, specifications etc; review and approve completed documentation post-execution•Identify, engage and direct activities of external manufacturing partners for raw material supply, product intermediate manufacture and supply, drug-fill-finish manufacturing operations and commercial supply•Co-ordination and project management between product development, device development, operations and customer functions,•Author and compile CMC sections of regulatory documentation - pre-IND, IND, Type C, NDA etc

Cambridge, Cambridgeshire, Gb

• Spearheaded development programme for novel platform for respiratory drug-device combination products (transition to low GWP propellant): energized and connected cross-functional subject matter experts to launch and deliver workstreams to achieve project feasibility and first-time-in-human clinical studies.Product and manufacturing process development, clinical trial planning and supply, pharmacological safety studies and supply, regulatory strategy and submissions, raw materials sourcing and supplier identification, program, timeline and budget management and communication.• Respiratory portfolio manufacturing for development, GMP, clinical and technical transfer operations to development, CMO and commercial manufacturing sites• Successfully mobilized outsourced expert and clinical trials manufacturing operations at Contract Manufacturing Organisations: searched and evaluated candidates, identified providers, technical transfer and relationship management.• Specialty drug product and excipient manufacture and purification (low GWP propellant), analytical characterization, toxicological/safety pharmacology evaluation.• Successfully executed turnaround of manufacturing operations team. Engaged and motivated individuals, created climate of teamwork, customer service and standardized processes. Achieved marked improvement in team performance and productivity.• Created Site Leadership Team. Built support and engagement from site leaders. Achieved improvement in site communication, employee engagement, participation, change leadership and cross-departmental alignment to corporate priorities

Us

• Successfully designed and developed product and manufacturing process from feasibility to commercial for a US-market respiratory generic drug-device combination product:Manufacturing product, process and equipment design and development, scale-up and technical transfer • Established and led pilot-scale and commercial manufacturing and quality control operations at multiple global internal and CMO sites; mobilized and managed suppliers and outsourced expert operations• Proficiently led product development programme, ensuring delivery of essential project milestones for development, regulatory filing and launch: Clinical trials planning, manufacture and supply; commercial manufacturing/launch preparation; continuous process improvement; development of robust, Quality-by-Design manufacturing process.• Compiled ANDA CMC section of regulatory dossier for FDA approval, IMPDs for MHRA clinical trial approval.Confidently interacted with FDA during review and on-site inspections, representing manufacturing process, bioequivalence and product/process development history. Proficiently responded to FDA Information Requests, Correctable Deficiencies

Chippenham, Wiltshire, Gb

• Successfully led the formulation and analytical development of novel dry powder inhalation therapy programmes (in-house and client driven) from feasibility through to clinical trials. • Championed turnaround of poorly-performing team to achieve high standards of productivity, engagement and customer service.

Brentford, Middlesex, Gb

• Formulation, analytical and manufacturing process development and technical transfer across respiratory portfolio - DPI, pMDI, Intra-nasal• Championed the development of robust, well-understood, controlled and continuously improved manufacturing processes across GSK respiratory portfolio and associated manufacturing unit operations. • Ensured successful, on-time delivery of development and clinical respiratory product manufacturing campaigns.• Led technical transfer of processes to commercial manufacturing and development sites Europe-wide.

Phd, Pharmacy

Master Of Business Administration (Mba)

Msc, Organisational And Business Psychology

Msc, Process Analytics & Quality Technology

Bsc, Chemistry

Authentic Leadership Coach, Coaching

German Language Cefr Level B2