Drug Product Support Lead, Biologics External Manufacturing Technical Operations
Job Description
We invite you to join our vibrant Biologics External Manufacturing team, where we collaborate across the US, EU, and Asia-Pacific to produce life-saving biologics products. We are looking for a passionate Drug Product Support Lead to provide technical guidance and expertise to our external partners.
About the Role
As the Drug Product Support Lead, you will report to the Technical Operations Lead and be responsible for offering technical support across our network of contract manufacturing organizations (CMOs). Your goal will be to ensure an efficient, robust, compliant, and cost-effective supply chain for our products. You will play a key role in supporting both commercial and pipeline products.
Bring energy, knowledge, innovation to carry out the following:
- Support a wide range of technical initiatives for vaccine and biologics products with both new and established CMOs.
- Lead complex investigations and facilitate right-first-time technology transfers, ensuring that all processes meet regulatory standards.
- Enhance process robustness and drive continuous improvement initiatives to optimize performance across the network.
- Foster a highly collaborative and inclusive environment within your team and across our interconnected global network, demonstrating a boundary-less organizational mindset.
What skills you will need:
In order to excel in this role, you will more than likely have:
Education and experience
- Bachelor’s degree in Engineering or Science required.
- Advanced degree in Engineering, Science, or Business preferred.
- Experience required:
- Approximately 12 years of relevant experience if you hold a Bachelor’s degree
- Approximately 10 years of relevant experience if you hold a Master’s degree
- Approximately 8 years of relevant experience if you hold a PhD
Skills requirements
- Strong technical expertise in vaccine and/or biologics drug product operations, with a proven track record in applying scientific knowledge and problem-solving approaches to deliver business results.
- Experience in vaccine and biologics manufacturing, including lyophilization.
- Direct experience leading technical transfers of drug product programs and solving complex problems.
- Ability to engage partners with a service-oriented mindset and communicate effectively with stakeholders, including senior leadership.
- Experience with vial and syringe filling is preferred.
- Lean Six Sigma certification or demonstrated experience in process improvement is a plus.
Travel requirements
- Willingness to travel 25-50% for partner assignments outside your primary location, including short-term travel as needed.
