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Scientist/Engineer - Tech Transfer

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Axelon Services Corporation

2024-11-06 09:42:13

Job location New Brunswick, New Jersey, United States

Job type: fulltime

Job industry: Science & Technology

Job description

Pay offers: 55$ to 60$/hr.

Job Description: 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 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 advanced degree program may consider as equivalent experience.

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