Senior Engineer, Drug Product Process Sciences (Fill/Finish)

Encoded-Therapeutics,-Inc.; Morrisville (NC); On-site; USD 150,000 - 210,000; Full time

Benefits offered by this job

Comprehensive benefits

Stock options

PTO & holidays

Parental leave

Pre-tax benefits

STD/LTD/Life/AD&D

Professional development

Team building

Wellness resources

Micro-kitchen

Job summary

Encoded Therapeutics, Inc. is seeking a Senior Engineer, Process Sciences (Drug Product) to help advance clinical and commercial AAV drug product manufacturing.

The role sits at the intersection of genomics and therapeutics and requires leading tech transfer and CQV strategies across sites. You will support URS development, collaborate with cross-functional teams, and serve as SME during regulatory inspections, with travel as needed.

Qualifications

• BS or MS in biochemical engineering, chemical engineering, biological sciences, virology, molecular biology, or biochemistry.
• 10+ years of industry experience or equivalent educational experience.
• 7+ years in MSAT/PD/Process Sciences role preferred.
• Hands-on experience with sterile fill-finish operations, aseptic processing preferred.
• Extensive knowledge of modern laboratory procedures and cGMP.
• Ability to independently design, execute, and analyze fill-finish and drug delivery studies.
• Ability to influence and develop cross-functional relationships.
• Strong verbal and written communication skills; ability to troubleshoot.
• Willingness to travel as needed; manage multiple technical deliverables.

Responsibilities

• Serve as engineer responsible for clinical, PPQ, and commercial Drug Product manufacturing for AAV products.
• Lead internal and external Tech Transfer for Drug Product manufacturing.
• Collaborate with cross-functional stakeholders to support URS development, vendor selection, FAT/SAT for internal Fill/Finish facility.
• Collaborate with cross-functional stakeholders to develop CQV protocols and equipment validation strategies.
• Provide on-site GMP support at internal and external manufacturing sites (clinical and commercial).
• Develop and maintain manufacturing performance trending tools.
• Develop tools/templates to support tech transfer business processes.
• Support regulatory filings and serve as SME during regulatory inspections.

Skills

MSAT/PD/Process Sciences

Fill/Finish operations

Aseptic processing

cGMP knowledge

Cross-functional collaboration

Regulatory support

Education

BS or MS in biochemical/chemical/biological sciences or related

Tools

Sterile fill-finish equipment

Job description

Encoded Therapeutics, Inc. is seeking a Senior Engineer, Process Sciences (Drug Product) to help advance clinical and commercial AAV drug product manufacturing.

The role sits at the intersection of genomics and therapeutics and requires leading tech transfer and CQV strategies across sites. You will support URS development, collaborate with cross-functional teams, and serve as SME during regulatory inspections, with travel as needed.