Senior Process Sciences Engineer – Gene Therapy Drug Product

Encoded Therapeutics; Morrisville (NC); On-site; USD 140,000 - 210,000; Full time

Benefits offered by this job

Competitive benefits package with prem

Stock option grants

PTO, sick time, holidays

Generous parental leave

Pre-tax medical and dependent care

STD, LTD, Life and AD&D

Professional development

Team-building events

Stocked micro-kitchen

Wellness resources

Job summary

Encoded Therapeutics is a clinical-stage genetic medicines company advancing CNS programs, including ETX101 for Dravet syndrome. We are seeking a Senior Engineer, Process Sciences (Drug Product) to lead manufacturing for AAV products and drive tech transfer and CQV strategies across clinical, PPQ, and commercial programs.

The role requires extensive MSAT/PD experience and strong cross-functional collaboration.

Qualifications

• B.S./M.S. in biochemical/chemical engineering, biological sciences, or related field.
• 10+ years of industry experience in MSAT/PD/Process Sciences or equivalent.
• 7+ years in MSAT/PD/Process Sciences role preferred.
• Hands-on with sterile fill-finish operations, aseptic processing preferred.
• Extensive knowledge of current laboratory practices and cGMP.
• Ability to independently design, execute, and analyze fill-finish and device studies.
• Ability to influence and collaborate with cross-functional stakeholders.
• Strong verbal and written communication, interpersonal, and problem-solving skills.
• Willingness to travel as required.
• Ability to manage multiple technical deliverables in a fast-paced, high-growth environment.

Responsibilities

• Own clinical, PPQ, and commercial Drug Product manufacturing for AAV products.
• Lead internal and external Tech Transfer for Drug Product manufacturing.
• Support URS development, vendor selection, FAT/SAT for internal Fill/Finish facility.
• Develop CQV protocols and equipment validation strategies.
• Provide person-in-plant support at internal and external GMP sites.
• Develop and maintain manufacturing performance trending tools.
• Create tools/templates to support tech transfer processes.
• Support regulatory filings and act as SME during inspections.

Job description

Encoded Therapeutics is a clinical-stage genetic medicines company advancing CNS programs, including ETX101 for Dravet syndrome. We are seeking a Senior Engineer, Process Sciences (Drug Product) to lead manufacturing for AAV products and drive tech transfer and CQV strategies across clinical, PPQ, and commercial programs.

The role requires extensive MSAT/PD experience and strong cross-functional collaboration.