Principal Scientist, Vector Manufacturing & Aseptic Process

US WorldMeds; Philadelphia (Philadelphia County); On-site; USD 150,000 - 210,000; Full time

Job summary

US WorldMeds is seeking a Principal Scientist (Vector) in Manufacturing Sciences and Technology to design and lead studies for product and process optimization. You will oversee aseptic process validation, technology transfer, and BLA-related characterization and investigations, ensuring regulatory compliance and audit readiness.

The role requires deep viral-vector knowledge, cross-functional collaboration, and leadership of a team to drive continuous improvement across LVP and outsourced

Qualifications

• B.S./M.S./Ph.D. with 4/8/10 years of industry experience respectively.
• Aseptic techniques and FDA/EU regulatory guidelines for validation.
• Experience with cGMP, Annex 1, and ATMP guidance.

Responsibilities

• Provide technical leadership for technology transfer and process optimization.
• Lead studies for characterization and development of pipeline products.
• Oversee LVV/Lentiviral processes and validation activities.
• Coordinate with QA, Regulatory, Analytical Sciences, and Facilities.
• Mentor junior scientists and manage small to mid-sized teams.
• Support audits and change controls with validation impact assessments.

Skills

Aseptic techniques

Cross-functional collaboration

Project management

Statistical data analysis

Viral vector production

Quality by Design (QbD)

Education

PhD in cell and/or molecular biology

MS in engineering or biology

BS in related field

Job description

US WorldMeds is seeking a Principal Scientist (Vector) in Manufacturing Sciences and Technology to design and lead studies for product and process optimization. You will oversee aseptic process validation, technology transfer, and BLA-related characterization and investigations, ensuring regulatory compliance and audit readiness.

The role requires deep viral-vector knowledge, cross-functional collaboration, and leadership of a team to drive continuous improvement across LVP and outsourced