Qualifications

• B.S or M.S. in biochemical engineering, chemical engineering, biological sciences, virology, molecular biology, or biochemistry.
• At least 10 years of industry experience or equivalent educational background.
• Minimum 7 years of experience in MSAT/PD/Process Sciences role preferred.
• Hands-on experience with sterile fill-finish operations and aseptic processing desired.
• Extensive working knowledge of modern laboratory procedures and cGMP compliance is essential.
• Proven ability to independently design and analyze fill-finish and drug delivery studies is required.
• Strong interpersonal skills to build relationships with various stakeholders.

Responsibilities

• Serve as an engineer overseeing clinical, PPQ, and commercial Drug Product manufacturing for AAV products.
• Lead tech transfer processes for Drug Product manufacturing, both internal and external.
• Collaborate with cross-functional teams to support URS development and vendor selection for Fill/Finish.
• Develop and implement CQV protocols and equipment validation strategies with stakeholders.
• Provide on-site support for GMP manufacturing at both internal and external manufacturing sites.
• Create and maintain tools for tracking manufacturing performance trends.
• Develop templates and tools to facilitate tech transfer business processes.

Benefits

• Comprehensive benefits package with competitive employer premium contributions.
• Meaningful stock option grants provided to employees.
• Generous PTO, sick time, and holiday pay.
• Supportive Parental Leave program available.
• Pre-tax medical and dependent care options offered.
• Coverage options for STD, LTD, Life and AD&D insurance.
• Opportunities for professional development and skill enhancement.
• Participate in team-building events and activities.
• Access to stocked micro-kitchen with snacks and drinks.
• Wellness resources are available to all employees.