Position: Scientist/Engineer 59856-1
Location: New Brunswick NJ 08903
Duration: 6+ months (possibility of extension for the right candidate depending on performance)
Pay rate: $60.73/ hour on W2
50% onsite required
Work Schedule: Normal business hours
Position Summary:
The Scientist provides technical support related to one or more Technology Transfer (TT) projects as well as provides 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 groups.
• 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 the 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 • Specific Knowledge, Skills, Abilities:
Required:
o Knowledge in Biologics/sterile liquid drug products, aseptic processing
o Experience in Biologics/Vaccine Aseptic Drug Product Manufacturing and/or Technology Transfer
o Ability to serve as a technical expert for Drug Product Manufacturing
o Strong critical thinking, technical writing, and verbal communication
o Demonstrated ability to:
§ Work in a matrix environment and effectively support the decentralized manufacturing function.
§ Effectively collaborate with other functions
Desired:
o 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 an advanced degree program may be considered equivalent experience.