BIOTECHNOLOGY
AND PHARMACEUTICAL ADVISORY

ABOUT

About

Charles Ross Advisory is a strategic consulting firm founded by Charles Ross, a seasoned leader in biotechnology and pharmaceutical manufacturing. The firm specialises in guiding life sciences organisations through the design, build, qualification, and operational readiness of GMP-compliant facilities, with a particular focus on start-ups, phase 1 requirements, aseptic processing and operational excellence.

Core Offerings

Translation from R&D, preclinical into Phase 1 clinical studies and beyond.
Facility Strategy & Execution: End-to-end support for biotech/pharma infrastructure projects—from concept to commissioning.
GMP & Quality Consulting: Expertise in compliance, validation, and operational readiness for sterile manufacturing environments.
Project Leadership: High-impact management of complex, multi-stakeholder initiatives, including cleanroom upgrades and new builds.
Strategic Communication: Tailored messaging and branding for technical audiences, investors, and ecosystem partners.
Mentoring & Ecosystem Development: Building capability and connection across the life sciences sector.

Professional Experience

Vaxxas – Head of Operations

Charles established and managed a full GMP operational process at the TRI including a suite of Standard Operating Procedures, multiple cleanroom qualifications, media fills and environmental monitoring system resulting in over 100 batch of clinical products being supplied to 5 clinical studies. In his tenure at Vaxxas, Charles secured significant funding and managed the design and build of the $35M Vaxxas Biomedical Facility.

Radpharm Scientific - General Manager

Charles was responsible for all site activities including production, engineering, business, quality, HR, warehouse/logistics, and projects. Charles successfully achieved a GMP aseptic licence extension followed by several positive TGA audits during his time at Radpharm.

Business Biotics Group - Company Director/Owner

Senior projects director and consultant for large-scale pharmaceutical projects. Managed several biocontainment and pharmaceutical projects at the Australian Animal Health Laboratories (PC4).

CSL Bioplasma LTD. ZLB Bioplasma Inc - Project Manager

Managed Phase III and commercial HD programs for the Hemostatic Dressing Project (American Red Cross and US Army collaboration). Tech transferred the process to CSL Swiss facility.

Qualifications & Affiliations

Adjunct Associate Professor (UQ), BEng (Chemical), Dip (Project Management)

Parenteral Drug Association Australian Chapter Board member Mar 2025 - present

Masters in Pharmaceutical Industry Practice Advisory Board 2019 - present

PATH Micro-projection Array Patch Sterility Working Group (2018-present)

Industry Mentoring Network in STEM (IMNIS) 2023 - present

Services

Corridors and door For Cleanroom manufacturing pharmaceutical plant, Epoxy flooring, Sandw

Facility Design & Build

Group of Vaccine bottles. Medicine in ampoules. Glass vials for liquid samples in laborato

GMP Manufacturing

SARS-COV-2 COVID-19 Coronavirus Vaccine Mass Production in Laboratory, Bottles with Brande

GMP Compliance

Automatic machine for filling ampoules and vials. Modern pharmaceutical equipment. Line fo

Sterile Manufacturing

Funding and business case development
Conceptual designs and layouts, particularity cleanroom and laboratory layouts.
Project briefs and operational readiness plans.
User requirement specifications, tendering and procurement of equipment including fill and finish lines, packing lines, autoclaves, lyophilisers and general process equipment.
User requirement specifications, tendering and procurement of GMP utilities and services including WFI system, PFS generators, compressed air systems and HVAC systems.
Biocontainment PC2 and PC3.
ISO8 to ISO 5 cleanrooms.
Environmental Monitoring and Environmental Monitoring Systems.

Batch documentation, Standard Operating Procedures for cleanroom cleaning, environmental monitoring, gowning etc.
Manufacturing process design.
Equipment tendering and procurement.
Warehousing and goods inwards systems.
Operational Excellence programs.
Problem solving in cleanrooms and aseptic processing.
Management Operating Systems.

PIC/S, TGA, APVMA, EMA and FDA.
Quality Management Systems requirements.
Contamination Control Strategies, Site Master Files and Site Validation Master Plans.
Mock TGA/APVMA audits, preparation and assistance with TGA audits
Equipment procurement, Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ).
Aseptic process validation.
Cleanroom IQ, OQ and PQ including Environmental Monitoring Plans.
GMP training and skills assessments across biotech/pharma operations.

Procurement and qualification of aseptic processing equipping including vial, prefilled syringes, blow fill seal and pillow packs presentations.
Media fill (process simulation) design.
Microbial investigations.

CONTACT

Get in touch

For further information on available services please email or call.

info@charlesross.com.au
Tel: +61 (0)474 202 550