Associate Manufacturing Engineer

Encoded Therapeutics•Morrisville, NC

About The Position

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 Associate 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.

Requirements

B.S. in engineering, life sciences, or related technical field, or A.S. degree with equivalent experience or H.S. Diploma and equivalent industry experience
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

Nice To Haves

B.S. degree in engineering, life sciences, or related technical field, or A.S. Degree with equivalent experience within a cGMP Manufacturing environment, or equivalent experience in a technical support role
1-2 years previous cGMP batch documentation authoring and lifecycle management experience
Ability to lift and/or move up 25 pounds and occasionally lift and/or move up to 50 pounds

Responsibilities

Use of MBRs and SOPs to produce clinical material from cell expansion through downstream processing in non-GMP and GMP settings.
Support Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) as well as equipment commissioning and validation, including associated reports and protocols.
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
Update and maintain Standard Operating Procedures (SOPs) and Master Batch Records (MBRs) for process execution and equipment operations in partnership with MSAT and QA.
Participate in investigations to determine a root cause for process deviations and author investigation reports
Support troubleshooting for process operations in the event of batch processing issues.

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

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