Senior Process Sciences Engineer - Drug Product (AAV)

Encodedgenomics; Morrisville (NC); On-site; USD 120,000 - 190,000; Full time

Job summary

Encoded Therapeutics seeks a Senior Engineer, Process Sciences (Drug Product) to drive clinical, PPQ, and commercial Drug Product manufacturing for AAV-based therapies. You will lead drug product tech transfer and work with cross-functional teams on URS, vendor selection, and validation strategies.

Ideal candidates have 10+ years in MSAT/PD/Process Sciences, hands-on sterile fill-finish experience, and strong cGMP knowledge.

Qualifications

• Bachelor or Master in biochemical/chemical engineering, biology, or biochemistry.
• 10+ years industry experience or equivalent.
• 7+ years in MSAT/PD/Process Sciences preferred.
• Hands-on sterile fill-finish and aseptic processing experience.
• Strong knowledge of cGMP and regulatory expectations.

Responsibilities

• Manufacture Drug Product for clinical, PPQ, and commercial needs.
• Lead internal and external tech transfer for Drug Product.
• Collaborate on URS, vendor selection, and FAT/SAT for Fill/Finish.
• Develop CQV protocols and equipment validation strategies.
• Provide person-in-plant support at internal/external sites.

Skills

MSAT/PD/Process Sciences

Fill-finish operations

Aseptic processing

cGMP knowledge

Cross-functional collaboration

Troubleshooting

Education

B.S./M.S. in biochemical/chemical engineering or related

Job description

Encoded Therapeutics seeks a Senior Engineer, Process Sciences (Drug Product) to drive clinical, PPQ, and commercial Drug Product manufacturing for AAV-based therapies. You will lead drug product tech transfer and work with cross-functional teams on URS, vendor selection, and validation strategies.

Ideal candidates have 10+ years in MSAT/PD/Process Sciences, hands-on sterile fill-finish experience, and strong cGMP knowledge.