Engineer, MSAT Req# 2118

Encoded Therapeutics

Raleigh, NC, US
  • Job Type: Full-Time
  • Function: Manufacturing
  • Post Date: 03/24/2021
  • Website: encoded.com
  • Company Address: 343 Oyster Point Blvd., Suite 100, South San Francisco, CA, 94080

About Encoded Therapeutics

A New Paradigm

Current treatment paradigms often address the symptoms of disease, not the cause, thus requiring chronic management. At Encoded, we leverage the power of the human genome to deliver highly effective precision therapies, leading to life-changing and lasting benefit for individuals with genetic disorders.

Job Description

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 Encoded MSAT team is expanding in 2021. We are seeking applicants to join or lead our team of talented engineers responsible for end-to-end technical support of GMP manufacturing. We are in the midst of key clinical production while also conducting studies in support of regulatory submissions. The team goals for 2021 will be continued delivery on GMP production and study execution while also building out the MSAT organization to establish GMP-enabling change management, comparability, and data management systems.

*Travel up to 25% expected as part of internal and external network engagement once business operations return to baseline.

Responsibilities:

  • Serve as an engineer responsible for process pre-clinical and clinical manufacturing for AAV projects and plasmid manufacturing; including upstream drug substance, downstream drug substance, fill/finish drug product, and drug delivery development.
  • Facilitate Encoded’s technology transfer of the ETX-101 process to internal and external sites of manufacturing; including process controls documentation, batch/solution record reviews and approvals, deviation closure, batch record review, data management, and other batch disposition support as requested.
  • Support Investigational New Drug (IND) application studies and report writing.
  • Work with the Director to develop process procedures and draft study plans as required to support process development and characterization, or to evaluate process conditions observed in GMP manufacturing.
  • Document all steps following GLP or GMP guidelines as indicated by phase of manufacture.

Requirements

  • B.S in a relevant area of specialization (biochemical engineering, chemical engineering, biological sciences, virology, molecular biology, or biochemistry)
  • 3 or more years of industry experience or equivalent educational experience
  • Extensive working knowledge of modern laboratory procedures and knowledge of cGMP
  • Extensive hands on industrial experience with in vitro cell culture methods, using suspension and adherent cell lines
  • Must be a team player and exhibit a willingness to meet project timelines
  • Strong verbal and written skills are required as well as effective interpersonal, technical, and troubleshooting skills
  • Outstanding planning, organization, and multitasking skills
  • Strong verbal and written skills are required as well as effective interpersonal, technical, and troubleshooting skills
  • Outstanding planning, organization, and multitasking skills

Preferred Qualifications:

  • M.S. in a relevant area of specialization (biochemical engineering, chemical engineering, biological sciences, virology, molecular biology, or biochemistry)
  • Experience with large scale disposable bioreactors
  • Experience or knowledge of separation technologies (column chromatography, tangential flow filtration)

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
  • LTD, Life and AD&D
  • Professional development opportunities
  • Team-building events
  • Fully stocked kitchen

Encoded Therapeutics, Inc. 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.

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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.