- Title: Scientist/Engineer
- Code: RCI-59856-1
- RequirementID: 121543
- Location: New Brunswick, NJ 08903
- Posted Date: 10/03/2024
- Duration: 6 Months
- Name:Mittal Mandavia
- Email: mittal.mandavia@rangam.com
-
Phone: 908-704-8843 ✖ 245
908-704-8843
Comments:
- 50% onsite required
- Work Schedule: Normal business hours
- Bachelor's degree required
Must Haves:
- Bachelor’s degree in engineering/science-related field with 3+ years of experience in the Biopharmaceutical field.
- Strong critical thinking, technical writing, and verbal communication
- Ability to work in a matrix environment and effectively support the decentralized manufacturing function.
- Knowledge in Biologics/sterile liquid drug products, aseptic processing
- 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:
- 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.
Travel:
- This position does not require travel.
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