Senior Engineer, Process Sciences – Drug Product

Encoded Therapeutics, Inc.; Morrisville (NC); Hybrid; USD 120.000 - 190.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

MSAT/PD/Process Sciences

Fill-finish operations

Aseptic processing

cGMP knowledge

Cross-functional collaboration

Troubleshooting

Ausbildung

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

Jobbeschreibung

Senior Engineer, Process Sciences – Drug Product

Department:

Internal Manufacturing

Locations:

Type:

Full time

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 visitwww.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

Requirements

• 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
• Comprehensive benefits package, including competitive employer premium contributions
• PTO, sick time, and holiday pay
• Generous Parental Leave program
• Pre-tax medical and dependent care programs
• STD, LTD, Life and AD&D
• 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].