MALCOLM JOHNSTON

Serve as the technical commercial interface for global clients, identifying key technical elements required for IND/BLA success while supporting global sales strategy.

• Engage US/EU clients to identify opportunities and translate technical needs into commercial strategies.
• Provide PD guidance to de-risk pipelines and improve readiness.
• Support commercial leadership in executing global sales strategy.
• Represented CMC technical strategy in client forums and steering committees; translated complex science into executable GMP plans.
• Prepared and presented reports on status of projects and initiatives.
• Networked with other professionals and organizations to expand contacts and opportunities.

Founded and led a CMC Technical Project Leadership (TPL) team owning programs from tech transfer through GMP (USP/DSP/AD)

• Increased right-first-time delivery and reduced technical delays by integrating quality earlier in PD workflows
• Reduced deviation count and investigation duration
• Developed a team of empowered Technical Project Leaders
• Implemented business tools and global workflows that improved schedule predictability and reduced delays
• Deep understanding of regulatory and ICH guidelines
• Oversaw internal and external contract manufacturing including raw materials and plasmids.
• Assisted senior leadership in managing all aspects of operations.
• Development and maintained the PD program strategy to ensure seamless delivery
• Developed project plans and managed project scope using methodologies to guide projects from conceptualization to implementation and disposition.
• Partnered with project team members to identify and quickly address problems.
• Led teams of up to 10 personnel, supervising daily performance as well as training and improvement plans.
• Trained and developed department leaders and management staff for specific projects and ongoing operational needs.

Designed, executed, and interpreted complex DSP studies; scaled and transferred processes from PD to GMP

• Provided DSP SME support across viral vectors (AAV, Ad5, CMV, Vaccinia), vaccines, and biologic's
• Managed multiple concurrent programs with strong technical oversight and RFT focus
• Developed and managed a team of downstream scientists

Led cross-functional USP/DSP/AD teams delivering PD and cGMP tech transfers for novel therapeutics

• Primary technical and client interface; owned milestones, margins, resources, and risk mitigation
• Developed and delivered complex biological programs from clinical to late phase in a phase appropriate manner.
• Developed and executed late-phase validation strategies; delivered end-to-end process readiness for GMP campaigns
• Increased project right first time by ensuring development of robust projects.
• Developed project plans and managed project scope using methodologies to guide projects from conceptualization to implementation and disposition.
• Partnered with project team members to identify and quickly address problems.
• Communicated project plans and progress to key stakeholders and project contributors.

• Led DSP activities for Phase I–III programs, including experimental design and process characterization
• SME in chromatography, filtration, UF/DF and other DSP disciplines
• Supported GMP readiness and execution at 100–5000 L (microbial & mammalian)
• Owned viral clearance and process scale-up
• Managed junior scientists and client technical communication

• Responsible for designing and executing complex scientific experiments during process development phases of the program lifecycle in a robust and compliant manner.
• Supported GMP readiness/execution at 100–5000 L
• Mentored junior team members.

• Executed purification studies and participated in client/technical discussions; managed timelines to program goals.