Reporting to the Chief Development and Operations Officer, the Head of CMC will proactively lead multiple vaccine projects coordinating with key internal and external stakeholders to advance our vaccine portfolio.
The primary responsibility of this position is to work collaboratively with a focus on effective communication, planning, coordination of activities, and efficient implementation of the CMC development and supply strategy.
The ideal candidate for this position will have demonstrated experience of integrated program/project management in the vaccine/biotechnology/biopharma industry.
From an operational and delivery perspective, the Head of CMC – Vaccine Development will:
- The Head of CMC is experienced in leadership, accountable for overall project implementation.
- Plan, schedule, and direct project activities to fulfill objectives and satisfy project requirements as defined with the client;
- Manage projects within established scope, schedule, and budget;
- Facilitate and lead effective project meetings, manage change and project team dynamics;
- Lead multiple R&D/CMC operations, analytical R&D/validation, process development, scale-up/manufacturing, R&D troubleshooting etc.
- Responsible for setting up CMC strategy and planning, including scenario building and risk management across development pathway: including drug substance, pharmaceutical and device development and manufacture of clinical trial material and planning for commercial manufacturing.
- Liaise with CMC technical leads as well as various functions within technical operations, including regulatory affairs, quality, and supply chain to ensure all CMC team deliverables and activities are aligned with all teams, departments and facilitate communication within the cross-functional team.
- Create detailed project plans, provide resource management, track project plan execution status against established targets as well as identify and facilitate resolution of issues, and communicate the project status.
To be successful in this role you will have experience in Senior Project Manager role within a similar company. You will have experience across the following:
- Bachelor’s degree in Biological Sciences, Bioengineering; Advanced degree is considered an asset.
- Experience in the pharmaceutical, biotechnology, and/or medical device industry with a primary focus on project/program management of CMC related activities.
- Experience utilizing project management tools and best practices to support CMC activities.
- Experience managing CMO/CRO relationships and projects.
- Familiarity with biological drug product development phases and regulatory requirements.
- Working knowledge of US and European regulatory requirements.
- Excellent written and verbal communication skills, analytic and problem-solving capabilities are essential.
- Strong competencies in planning, project management, and organization with the ability to lead multiple activities and resources while maintaining a focus on quality.
- Solid analytical and strategic capabilities combined with business acumen and a demonstrated track record of work ethic, integrity, and professional conduct and appearance.
- Exceptional interpersonal and leadership skills to effectively communicate and build working relationships with a broad spectrum of audiences at all organizational levels.
- Proven interpersonal, influencing skills and excellent oral and written communications skills.
- Commitment to achieving corporate objectives while maintaining the highest ethical, regulatory, and scientific standards.
- An entrepreneurial, innovative, energetic, hands-on, team oriented, and customer focused, attitude and approach.
- The ability to think strategically as well as execute project details.
- Ability and strong desire to work in a dynamic “scale-up” environment and be able travel from time to time domestically and/or internationally.
If you are excited by the prospect of the challenges and enjoy rolling up your sleeves, we want to hear from you.
To be considered, please submit your resume and a cover letter (outlining your core capability for the role, demonstrated experience of how you have delivered outcomes and why this role is of interest) both in Word format by selecting the “apply now” function.
Confidential enquiries can be made to Peter Starling, Senior Client Partner on 07 3305 5830 or 0433 422 518.