Senior Engineer, Process Sciences - Drug Product

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 is a clinical-stage genetic medicines company developing potentially disease-modifying therapies to improve the lives of people with severe CNS disorders. Our proprietary vector engineering approach combines novel regulatory elements and payloads with AAV vectors to unlock innovative solutions for debilitating, intractable CNS conditions. At the forefront is our flagship clinical program, ETX101 for Dravet syndrome, which targets the underlying cause of the disorder to enable highly selective upregulation ofSCN1Afor potentially long-lasting benefit. In parallel, we are advancing a pipeline of potentially best-in-class programs to address significant unmet needs across both monogenic and prevalent CNS conditions. For more information, please visit www.encoded.com.

We are recruiting a Senior Engineer, Process Sciences (Drug Product) to join our team. This is a unique opportunity to work at the intersection of genomics and therapeutics and participate in the development of a diverse therapeutic pipeline driven by a transformative core technology. The successful candidate will work well across multiple projects in a fast-paced and dynamic environment.

Responsibilities

• Serve as an 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 person-in-plant support of GMP (clinical and commercial) manufacturing as required at internal and external sites of manufacturing
• Develop and maintain manufacturing performance trending tools
• Work with cross-functional teams to develop tools/templates to support tech transfer business processes
• Support regulatory filings and serve as technical SME during regulatory inspections

Qualifications

• B.S or M.S. in a relevant area of specialization (biochemical engineering, chemical engineering, biological sciences, virology, molecular biology, or biochemistry)
• At least 10 years of industry experience or equivalent educational experience
• At least 7 years of experience in MSAT/PD/Process Sciences role preferred
• Hands-on experience with sterile fill-finish operations, aseptic processing preferred
• Extensive working knowledge of modern laboratory procedures and knowledge of cGMP is a must
• Ability to independently design, execute, and analyze fill-finish and drug delivery device studies (extractable volume, formulation development, device compatibility) is a must
• Ability to influence, build, and develop strong working relationships with cross-functional stakeholders
• Strong verbal and written skills are required as well as effective interpersonal, technical, and troubleshooting skills
• Availability to travel based on business need, at times with minimal advanced notice
• Ability to manage multiple technical deliverables in a fast-faced, high-growth environment

Benefits

• Comprehensive benefits package, including competitive employer premium contributions
• Meaningful stock option grants
• PTO, sick time, and holiday pay
• Generous Parental Leave program
• Pre-tax medical and dependent care programs
• STD, LTD, Life and AD&D
• Professional development opportunities
• Team-building events
• Stocked micro-kitchen with drinks and snacks
• Wellness Resources

Encoded is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind.

Encoded is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment.

All employment decisions at Encoded are based on business needs, job requirements and individual qualifications, without regard to race, religion or belief, color, national origin, gender, status as a protected veteran, status as an individual with a disability, or any other status protected by the laws or regulations in the location in which we operate.

Encoded will not tolerate discrimination or harassment based on any of these characteristics.

Encoded encourages applicants of all ages.

If you need assistance or an accommodation due to a disability, you may call us at [phone].