About this opportunity
Encoded Therapeutics Inc. lists this Senior Engineer, Process Sciences - Drug Product opportunity in morrisville, North Carolina. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Encoded Therapeutics is a clinical-stage genetic medicines company developing potentially disease-modifying therapies to improve the lives of people with severe CNS disorders. Our proprietary vector engineering approach combines novel regulatory elements and payloads with AAV vectors to unlock innovative solutions for debilitating, intractable CNS conditions. At the forefront is our flagship clinical program, ETX101 for Dravet syndrome, which targets the underlying cause of the disorder to enable highly selective upregulation of SCN1A for potentially long-lasting benefit. In parallel, we are advancing a pipeline of potentially best-in-class programs to address significant unmet needs across both monogenic and prevalent CNS conditions. For more information, please visit
Responsibilities
Serve as an engineer responsible for clinical, PPQ, and commercial Drug Product manufacturing for AAV products
Lead internal and external Tech Transfer for Drug Product manufacturing
Collaborate with cross-functional stakeholders to support URS development, vendor selection, FAT/SAT for internal Fill/Finish facility
Collaborate with cross-functional stakeholders to develop CQV protocols and equipment validation strategies
Provide person-in-plant support of GMP (clinical and commercial) manufacturing as required at internal and external sites of manufacturing
Develop and maintain manufacturing performance trending tools
Work with cross-functional teams to develop tools/templates to support tech transfer business processes
Support regulatory filings and serve as technical SME during regulatory inspections
Requirements
B.S or M.S. in a relevant area of specialization (biochemical engineering, chemical engineering, biological sciences, virology, molecular biology, or biochemistry)
At least 10 years of industry experience or equivalent educational experience
At least 7 years of experience in MSAT/PD/Process Sciences role preferred
Hands-on experience with sterile fill-finish operations, aseptic processing preferred
Extensive working knowledge of modern laboratory procedures and knowledge of cGMP is a must
Ability to independently design, execute, and analyze fill-finish and drug delivery device studies (extractable volume, formulation development, device compatibility) is a must
Ability to influence, build, and develop strong working relationships with cross-functional stakeholders
Strong verbal and written skills are required as well as effective interpersonal, technical, and troubleshooting skills
Availability to travel based on business need, at times with minimal advanced notice
Ability to manage multiple technical deliverables in a fast-faced, high-growth environment
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 .
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Worksite address
morrisville, NC, 27560, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.