We are seeking a senior professional to provide technical oversight and support for vaccine drug substance and/or drug product processes. The successful candidate will ensure compliance with regulatory requirements.
1. Provide technical expertise for vaccine manufacturing processes, ensuring adherence to established protocols.
2. Support equipment qualification, water runs, and process performance qualification activities.
3. Collaborate with cross-functional teams to guarantee successful commercial manufacture.
4. Author process change control documentation, technical reports, and risk management strategies.
5. Develop and implement complex partnership models, providing technical guidance and planning support.
6. Lead team efforts in identifying and mitigating partner risks, ensuring business continuity.
A bachelor's degree in engineering or a related science is required. An advanced degree in engineering, science, or business is highly desirable.
Minimum of 5 years of experience in pharmaceutical manufacturing, engineering, or technical operations support is necessary.