Manufacturing Engineer

Encoded Therapeutics Inc. is a biotechnology company advancing precision medicines for a broad range of genetic disorders. Our mission is to unlock new opportunities for viral gene therapy through genomics-driven discovery. We focus on delivering life-changing advances for individuals with genetic disorders not addressable with current approaches. For more information, please visit www.Encoded.com.

The Manufacturing Engineer is responsible for contributing to facility start up and tech transfers by owning an assigned unit operation from the manufacturing process and driving the associated start up activities for the materials, equipment, and operational readiness.  In addition, this individual will perform manufacturing operations for internal material supply runs at the NC Pilot Plant.

The level of this position will be based on the final candidate’s qualifications and be reflected in assigned unit operation scope and deliverables.

Workplace Model: Onsite

Responsibilities

• Ownership of associated equipment, materials, and operational readiness for one or more process steps.
• Execute Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) as well as equipment commissioning and validation, including associated reports and protocols.
• Serve as lead Manufacturing representative in Tech Transfers. Assess incoming products against existing Manufacturing Ecosystem and work as part of Tech Transfer to ensure successful scale-up and process implementation.
• Work with Supply Chain and MSAT to maintain operational readiness for a variety of processing scales by identifying preferred materials for unit operations as well as acceptable substitute items
• Develop and author Standard Operating Procedures (SOPs) and Master Batch Records (MBRs) for process execution and equipment operations in partnership with MSAT and QA.
• Create associated training materials and provide training for internal and external sites of manufacturing.
• Conduct investigations to determine a root cause for process deviations and author investigation reports
• Use of MBRs and SOPs to produce clinical material from cell expansion through downstream processing in non-GMP and GMP settings.
• Perform troubleshooting for process operations in the event of batch processing issues.

Requirements

• B.S. Degree in engineering, life sciences, or related technical field, or A.S. Degree with equivalent experience within a cGMP Manufacturing environment or academic equivalent
• Strong ability to manage time and balance multiple priorities
• Proven cross-functional collaborator
• Excellent oral and written communication skills
• Ability to have a flexible schedule to support a multi-shift operation that covers nights and weekends as needed
• Up to 20% travel required

Preferred Qualifications

• B.S. in a relevant area of specialization (biochemical engineering, chemical engineering, biological sciences, molecular biology, or biochemistry), or equivalent industry experience
• 1-2 years previous cGMP batch documentation authoring and lifecycle management experience
• 1 or more years previous equipment commissioning, qualification, validation experience
• Previous electronic manufacturing systems creation or management
• Ability to lift and/or move up 25 pounds and occasionally lift and/or move up to 50 pounds

The anticipated salary range for candidates who will work in North Carolina is $87,540 - $110,452. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, education, etc. Encoded Therapeutics is a multi-state employer and this salary range may not reflect positions that work in other states.

A hired applicant may be eligible for an annual bonus as well as equity under the company’s stock plan.