Scientist/Engineer

Job Title: Scientist/Engineer

Location: New Brunswick, NJ (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.

Must Haves:

• Bachelors 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

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.