Title: Technology Transfer Scientist
Location: New Brunswick, NJ- Hybrid (50% onsite)
Duration: 6 months+
Position Summary:
- The Scientist provides technical support related to one or more Technology Transfer (TT) projects as well as provide support to the Product Champion cluster.
This position is accountable for working together with the TT Lead to ensure various project aspects are supported from a technical perspective as well as a timeline perspective.
This position is responsible for supporting the Product Champion group through Data Verification (DV) activities, change control support, improvement projects, etc.
Duties/Responsibilities:
- Support TT Lead for one or more projects
- Actively participates in TT meetings, collaborating with cross-functional group.
- Responsible for detailed reviews of project documents such as protocols, reports, risk assessments, and MBRs.
- Provides assistance to sites to review/resolve quality events as needed.
- Collaborate on TT project definition and support-chartered projects as needed.
- Identifies TT issues/risks and proposes ideas for issue resolution. Supports issue resolution as needed.
- Support Product Champion Cluster
- Support DV of various product TTs and lifecycle projects.
- Support improvement projects for Product Champion group.
- Identify opportunities for improvement and provide ideas to implement.
- Collaborate with Product Champions and work together to learn about different products and implement various improvements.
- Reporting Relationship Reports to Product Champion Cluster Lead
Required:
Knowledge in Biologics/sterile liquid drug products, aseptic processing
Experience in Biologics/Vaccine Aseptic Drug Product Manufacturing and/or Technology Transfer
Ability to serve as a technical expert for Drug Product manufacturing
Strong critical thinking, technical writing, and verbal communication
Demonstrated ability to:
Work in a matrix environment and effectively support the decentralized manufacturing function.
Effectively collaborate with other functions
Desired:
- Thorough knowledge of quality systems, Quality by Design, validation principles for product and engineering design and process control fundamentals
Education/Experience/ Licenses/Certifications:
- Required bachelor's degree in engineering/science-related field with 3-5 years of relevant experience. Time spent in advanced degree program may consider as equivalent experience.