Scientist II, Downstream Process Development

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.

Position details

Encoded is seeking a Scientist to play a leading role in our Downstream Process Development group. The candidate will apply technical knowledge and experience to design and improve unit operations for purification of Encoded's AAV-based therapeutic candidates. The Downstream Process Development team operates with the mission to develop high-performing, scalable, robust, and cost-effective viral vector purification strategies for use in clinical manufacturing. The candidate will collaborate closely with other members of Process Development, as well as MSAT, Research Vector Production, and Analytical Development teams. Development of our platform process will include innovation and optimization of harvest clarification, chromatography, and tangential-flow filtration unit operations, as well as process transfer activities. As programs advance into clinical development and toward commercialization, expanded process knowledge will be applied toward support of regulatory filings.

This is a unique opportunity to join a high-performing team that is at the forefront of Gene Therapy process development. The successful candidate will build upon their deep knowledge base and considerable experience to become an expert in the field. By enhancing our ability to manufacture rAAV vectors, our work will directly contribute to enabling gene therapies for broader and more challenging indications.

Workplace Model{{:}} Onsite

Responsibilities

• Design, carry out, and interpret purification studies necessary to support pre-clinical development for rAAV-based gene therapies
• Provide technical expertise in purification technologies and protein chemistry, applied toward of AAV viral vectors
• Operate chromatography (affinity, ion-exchange, multi-modal) and filtration (tangential flow, depth filtration, virus retentive) unit operations for production of preclinical rAAV drug substance
• Contribute to development of long-term PD platform strategy, including initiatives to improve process understanding, product quality, step yields, and cycle times
• Collaborate across broader PD, AD, and MSAT departments for study, scaling, and implementation of new process technologies
• Author technical reports and contribute to regulatory documents
• Assist with group-level planning and conduct initiatives to improve workflows
• Management of 2 direct reports
• May include approximately 20% remote work, with flexibility based on project needs
  
  

Requirements

• BS+8 / MS+6 / PhD+2 years minimum industry experience in a process development or MSAT role
• Degree in a related field, including chemistry, biochemistry, chemical / biochemical engineering, or virology
• Excellent communication and presentation skills. Capability to convey complex technical information in a clear, concise, and influential manner
• Enthusiasm for collaborative work in a dynamic environment, plus individual accountability within areas of responsibility
• Proficiency writing methods for Unicorn
  
  

Preferred Qualifications

• Prior experience developing purification processes for virus, VLP, or gene therapy vectors for GMP clinical manufacturing
• Experience with single-stranded and self-complementary AAV chromatography-based downstream processes
• Experience with CsCl and Iodixanol Ultracentrifugation AAV purification processes
• Experience running Refyn, alkaline gel, CE-SDS, SEC-HPLC, and other similar analytical assays
• Working knowledge of the GMP manufacturing environment, which may include involvement in process transfer, review of batch records/deviations/CAPAs, or ‘person-in-plant' duties.
• Experience with process characterization including viral clearance studies
• Familiarity with regulatory standards for investigational therapeutics (biologics or gene therapy), which may include contributions to IND or CTA filings
• Skilled in statistical analysis and DoE methodologies, and familiarity with JMP, MiniTab, or DesignExpert software
• Prior engagement in LIMS initiatives
  
  

The anticipated salary range for Scientist II candidates who will work in California is $120,000 - $142,000. This position may also be filled at the Scientist I level with an anticipated salary range of $112,000 - $138,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, education, etc. Encoded Therapeutics is a multi-state employer and this salary range may not reflect positions that work in other states.

A hired applicant may be eligible for an annual bonus as well as equity under the company's stock plan.

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
• Fully stocked kitchen
• Purple Tie dry cleaning service
• Fitness center
  
  

Employees (and their families) may obtain medical, dental, vision and basic life insurance benefits through the company and enroll in our company's 401k plan. Employees will also accrue vacation time off and paid sick time off and may become eligible for paid parental leave. Employees will also enjoy designated paid holidays throughout the calendar year.

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.