Engineering - Scientist/Engineer Scientist/Engineer

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.

Travel :

This position does not require travel.

Additional Job Requirements :

None

EEO :

Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of Minority / Gender / Disability / Religion / LGBTQI / Age / Veterans.