CMC Lead (Vaccines)

CSL Plasma•Holly Springs, NC

About The Position

This role is responsible for leading project-specific Chemistry, Manufacturing and Control (CMC) matrix teams. The primary responsibility and accountability of the role is to define and deliver contemporary CMC packages during clinical development, market authorization, and Life Cycle Management (LCM). During early clinical development, the CMC Lead defines the manufacturing plan and ensures clinical supply. The role provides technical guidance, operational coordination, and cross-functional leadership within and across Integrated Project Teams (IPTs), aligning CMC activities with program objectives.

Requirements

Bachelor’s degree in a relevant scientific or technical field (e.g., Biochemistry, Pharmaceutical Sciences, Chemical or Biomedical Engineering, Biotechnology, Biology/Chemistry, etc.)
10+years of experience in pharmaceutical industry with emphasis on manufacturing operations, process design, and process validation
Demonstrated experience in project management and/or leadership by influence preferred
Advanced knowledge of biological manufacturing processes and advanced CMC/QbD requirements for plasma derived or biotechnology therapies is preferred
Technical and regulatory writing experience
Previous experience working across sites and as part of international teams is highly desirable
Track records in leading teams is crucial to perform in this role
Fluent in English
Strong problem-solving capabilities with a proactive, solution-oriented approach
Deep knowledge of CMC principles, lifecycle management strategies, and regulatory requirements such as ICH guidelines
Strong matrix leadership and program management skills with the ability to maintain strategic focus over long project timelines
Requires sustained focus and engagement over extended project timelines
Ability to manage multiple priorities and navigate complex matrixed environments
May involve significant periods of on-site presence at manufacturing or partnering organizations and CDMO locations during key phases
Periodic travel for project-related activities ( frequency and locations dependent to be further defined )

Nice To Haves

Advanced degree (MS or PhD) in a related field strongly preferred
Previous experience working across sites and as part of international teams is highly desirable

Responsibilities

Lead CMC project teams for assigned programs, ensuring execution of process, analytical, and manufacturing plans to meet development milestones
Define and deliver phase-appropriate control strategies, including contributing to product specifications in collaboration with technical subject matter experts.
Support authoring and review of CMC sections for regulatory submissions, applying established regulatory guidance and basic QbD principles
Accountable for delivery of the Quality Section during clinical development, market authorization, and LCM changes
Maintain line-of-sight to manufacturing delivery (contracts, production, validation, regulatory activities) in collaboration with sites and partners
Ensure effective communication of CMC strategies, objectives, and progress within project teams, IPTs, and relevant stakeholders
Accountable for CMC/QbD related project and product documentation (for example: risk assessments, PFMEAs, monitoring strategies) in accordance with relevant policies
Collaborates across IPTs to assure alignment and continuous improvement on best practices for QbD and CMC development