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Encoded Therapeutics Inc. · 17 hours ago

Associate Manufacturing Engineer

Morrisville, NC

Full-time

Onsite

Entry Level

1+ years exp

Encoded Therapeutics Inc. is a biotechnology company focused on advancing precision medicines for genetic disorders. The Associate Manufacturing Engineer will contribute to facility start-up and tech transfers, managing assigned unit operations and performing manufacturing operations at the NC Pilot Plant.

BiotechnologyGeneticsHealth CareTherapeutics

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

Qualification

CGMP ManufacturingBatch documentation authoringTechnical support experienceOralTime managementCross-functional collaborationWritten communication

Required

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

Preferred

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

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

Company

Encoded Therapeutics Inc.

Encoded Therapeutics is creating one-time, disease-modifying gene therapies for pediatric central nervous system (CNS) disorders with its cell-selective targeting and regulation platform.

Founded in 2014

South San Francisco, California, USA

51-200 employees