I am Srinivas from Futran Solutions. My client is looking for the below requirement. If you are interested. Please reach me out msrinivas@futransolutions.com / (609)-945-2335, Ext: 9068
Location: New Brunswick, NJ - Hybrid - 50% onsite required
Work Schedule: Normal business hours
Must Haves:
o Bachelor's degree in engineering/science-related field with 3+ years of experience in the Biopharmaceutical field.
o Strong critical thinking, technical writing, and verbal communication
o Ability to work in a matrix environment and effectively support the decentralized manufacturing function.
o Knowledge in Biologics/sterile liquid drug products, aseptic processing
o Experience in Biologics/Vaccine Aseptic Drug Product Manufacturing and/or Technology Transfer
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
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 as equivalent experience.