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.
Encoded is seeking a Scientist that will serve to provide Downstream Process Development support for early-stage gene therapy candidates. As a technical leader in the Downstream Process Development group, the candidate will creatively use technical knowledge and experience to design and improve manufacturing processes for Encoded’s AAV-based therapeutics. The Downstream Process Development team operates with the mission to develop innovative, scalable, robust, and cost-effective viral vector purification strategies to ensure timely manufacturing of drug substances to support early-stage programs at Encoded. The candidate will collaborate closely with other members of Process Development and cross-functional teams to advance internal AAV purification platforms, support technology transfer activities, develop innovative harvest clarification, chromatography, and filtration unit operations to support a wide range of therapeutic opportunities while supporting clinical regulatory filings with an eye towards commercialization.
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 team environment.
- Design, carry out, and interpret experiments. Lead scale-up activities from bench to clinical production scale. Evaluate process initiatives necessary to support pre-clinical development for ongoing CMC projects.
- Drive initiatives to evaluate novel technologies, develop next-generation templated process platforms, and achieve technical benchmarks to support organizational growth.
- Promote and support the evaluation of new process technologies and initiatives to improve process understanding and product quality, to increase product yield, and to reduce cost of goods and unit operation cycle times.
- Serve as a subject-matter-expert on the downstream purification of AAV viral vectors using chromatography (i.e., affinity, ion-exchange, multi-modal) and filtration technologies (i.e., tangential flow filtration, depth filtration, virus removal).
- Contribute to technical reports and both internal and external presentations. Author regulatory documents.
- May manage one or more associate or scientist level employees
- Ph.D. in a relevant area (biochemistry, biochemical engineering, chemical engineering, biological sciences, or virology) with 1-5 years of industry, academic or post-doctoral experience; or
- BS/MS with 8-11 years in a relevant area of specialization with extensive industry and/or academic experience
- Proven track-record with early-stage process development, experience with process characterization including viral clearance studies
- Excellent communication and presentation skills, capable of conveying complex technical information and experimental results and plans in a clear, concise, and influential manner to relevant cross-functional teams such as Process Development, Manufacturing Sciences and Technology (MSAT), Manufacturing, Analytical Development, Quality, and Regulatory.
- Must be a team player, exhibit a willingness to meet project timelines and multitask effectively.
- Proficiency in Microsoft Excel, PowerPoint, and Word, Unicorn, JMP and DoE, statistical analysis, LIMS based system(s), ELN, StartingPoint or equivalent eCTD software, and Empower are strongly desired.
- Familiarity with regulatory expectations for biological products, and experience authoring CTD sections for pre-IND and IND filings Experience with purification of AAV-based vectors
- 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
- Fully stocked kitchen
- Purple Tie dry cleaning service
- Fitness center
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.