Scientist/Engineer
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Job Description
Job Description:
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.
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
Collaborate on TT project definition and support chartered projects
Identifies TT issues/risks and proposes ideas for issue resolution. Supports issue resolution
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
Qualifications
Requires a Bachelor's degree in Engineering or Science-related field with 3+ years of experience in the Biopharmaceutical field.
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
Time spent in advanced degree program may consider as equivalent experience.