Scientist/Engineer in New Brunswick, NJ

  • Title: Scientist/Engineer
  • Code: RCI-59856-1
  • RequirementID: 121543
  • Location: New Brunswick, NJ 08903
  • Posted Date: 10/03/2024
  • Duration: 6 Months
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  Job Description

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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