Senior Engineer, Process Sciences - Drug Product

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 www.encoded.com. We are recruiting a Senior Engineer, Process Sciences (Drug Product) to join our team. This is a unique opportunity to work at the intersection of genomics and therapeutics and participate in the development of a diverse therapeutic pipeline driven by a transformative core technology. The successful candidate will work well across multiple projects in a fast-paced and dynamic environment. Responsibilities Serve as an engineer responsible for clinical, PPQ, and commercial Drug Product manufacturing for AAV productsLead internal and external Tech Transfer for Drug Product manufacturingCollaborate with cross-functional stakeholders to support URS development, vendor selection, FAT/SAT for internal Fill/Finish facilityCollaborate with cross-functional stakeholders to develop CQV protocols and equipment validation strategiesProvide person-in-plant support of GMP (clinical and commercial) manufacturing as required at internal and external sites of manufacturingDevelop and maintain manufacturing performance trending toolsWork with cross-functional teams to develop tools/templates to support tech transfer business processesSupport 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 experienceAt least 7 years of experience in MSAT/PD/Process Sciences role preferredHands-on experience with sterile fill-finish operations, aseptic processing preferredExtensive working knowledge of modern laboratory procedures and knowledge of cGMP is a mustAbility to independently design, execute, and analyze fill-finish and drug delivery device studies (extractable volume, formulation development, device compatibility) is a mustAbility to influence, build, and develop strong working relationships with cross-functional stakeholdersStrong verbal and written skills are required as well as effective interpersonal, technical, and troubleshooting skillsAvailability 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 contributionsMeaningful stock option grantsPTO, sick time, and holiday payGenerous Parental Leave programPre-tax medical and dependent care programsSTD, LTD, Life and AD&DProfessional development opportunitiesTeam-building eventsStocked micro-kitchen with drinks and snacksWellness 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 +1 650-491-0272.