Manufacturing Engineer - cGMP Gene Therapy Production

Encoded Therapeutics Inc.; Morrisville (NC); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Comprehensive benefits package

Stock option grants

Paid time off

Parental leave

Wellness resources

Job summary

Encoded Therapeutics Inc. is seeking a Manufacturing Engineer in Morrisville, NC to execute end-to-end batch production for gene therapy campaigns.

You will maintain a compliant environment, troubleshoot issues, and collaborate with QA, Process Sciences and Supply Chain to enable scale-up and readiness across processing scales. The role requires 2+ years in a cGMP setting producing biologics, strong communication, and the ability to work across shifts including nights and weekends.

Qualifications

• Minimum of 2 years in a cGMP environment producing a biologic product.
• Strong cross-functional collaboration and communication skills.
• Ability to manage multiple priorities in a fast-paced setting.
• Willing to work a multi-shift operation including nights and weekends.
• Travel up to 10%.

Responsibilities

• Execute end-to-end batch production from cell expansion to final filtration and dose aliquot preparation.
• Maintain a compliant manufacturing environment through documentation, waste disposal, equipment checks, and facility cleanliness.
• Troubleshoot batch processing issues and escalate as needed.
• Author Process Records, SOPs and Master Batch Records with Process Sciences and QA.
• Own manufacturing investigations including deviation root-cause analysis, change controls, and CAPAs.
• Tech Transfer to assess incoming products against existing infrastructure for scale-up.
• Support equipment validation, FAT/SAT, and commissioning; train internal and external sites.

Skills

Cross-functional collaboration

Excellent written and verbal comms

Time management

Adaptability

Flexible schedule

Travel up to 10%

Team player

Education

B.S. in Engineering or Life Sciences

Job description

Encoded Therapeutics is a clinical-stage biotechnology company developing precision genetic medicines to transform the lives of patients with severe neurological disorders. The company's vector engineering platform enables potent and cell-type-selective regulation of gene expression, allowing for targeted modulation of disease-relevant genes. Encoded is advancing a pipeline of programs across genetic epilepsies and other neurological disorders with significant unmet need. With integrated discovery, development, and manufacturing capabilities, Encoded is positioned to efficiently move programs from concept through the clinic. Encoded is driven by a mission to meaningfully improve the lives of patients and families affected by devastating neurological disorders. For more information, please visit www.encoded.com.

We are seeking a mission-driven Manufacturing Engineer to execute critical production runs across both cGMP and non-cGMP Gene Therapy campaigns. This role offers a unique opportunity to contribute to a high-growth environment across multiple facets of the business (for example, CMC, Technology Transfer, Supply Chain and Quality) with primary duties focused on production execution.

Please note - this position is based in Morrisville, North Carolina, and relocation assistance is not available for this role.

Core Responsibilities

Production & Operations

• Execute Batch Production - Perform end-to-end batch operations, including solution preparation and major unit operations from cell expansion through final filtration, bottling, and dose aliquot preparation
• Maintain Quality - Ensure a compliant manufacturing environment through documentation execution, waste disposal, equipment checks, instrument standardization, and facility cleanliness
• Process Troubleshooting - Perform real-time troubleshooting for batch processing issues and elevate to leadership as appropriate

Technical Documentation

• Author Process Records - Develop and maintain Standard Operating Procedures (SOPs) and Master Batch Records (MBRs) in partnership with Process Sciences and Quality assurance (QA)
• Manage Exceptions - Own manufacturing investigations, including deviation root-cause analysis, change controls, and CAPAs

Production Support

• Tech Transfer - Assess incoming products against existing infrastructure to ensure successful scale-up and process implementation
• Operational Readiness - Partner with Supply Chain and Process Sciences to identify preferred materials to ensure readiness across various processing scales
• Equipment Validation and Onboarding - Support Factory/Site Acceptance Testing (FAT/SAT) as well as equipment commissioning and validation protocols
• Knowledge Sharing - Create training materials and provide instruction for internal and external manufacturing sites while maintaining individual training compliance

Requirements

• Industry Experience - Minimum of 2 years of direct experience in a cGMP environment producing a biologic product
• Collaboration - Proven cross-functional collaborator and teammate
• Communication - Excellent oral and written communication skills
• Adaptability - Strong ability to manage time and balance multiple priorities in a fast-paced environment
• Flexibility - Ability to support a multi-shift operation that covers nights and weekends as needed
• Travel - Ability to travel up to 10%
• Physical - Ability to lift and/or move up to 25 pounds regularly and occasionally up to 50 pounds

Preferred Requirements

• Education - B.S. degree in an Engineering or a Life Sciences focused major.
• Technical Expertise - 1+ years of proficiency in batch production

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].