External Manufacturing
Purpose
This is a 12 month contract
This position will be the key technical leader interface with the External Partner for the Large Molecule Drug Product (ExM) organization. This individual will create, lead, and execute technical transfer to and commercial supply for Vaccine(s) from External Partner(s). This role is critical to the organization’s ability to support in-line commercial product technology transfers of vaccine drug substance to External Partner, and support of our in-line products, with sharp oversight and technical risk management.
Responsibilities
The primary focus of the Technical Transfer Lead is to provide technical and project leadership to Large Molecule Vaccines External Manufacturing business for:
- Technical transfer of drug product processes to EP, including but not limited to person-in-plant support, directly within the EP manufacturing facility:
- review manufacturing documents including batch record check, standard operating procedures, job aids, and protocols
- process troubleshooting.
- support manufacturing investigations
- review analytical results
Requirements
- A Bachelor’s degree in Engineering or applicable Science is required. An advanced degree in Engineering, Science, or Business is preferred.
- Minimum of 6 to 8 years post-bachelor’s degree experience in Large Molecule Drug Product manufacturing, engineering, and/or technical support of operations is required.
- Advanced problem-solving skills and experience leading teams to resolve complex business or technical issues is required.
- Excellent leadership, collaboration, change management, interpersonal, analytical skills, collaboration, and engagement as a team player with dependable interpersonal and communication skills (both verbal and written) is required.