Encoded Therapeutics

Associate Director/Principal Scientist, Process Development, Cell Culture

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.

We are recruiting a Process Development Associate Director or Principal to assist in building improved process technologies for rAAV expression. This is a rare opportunity to enter an emerging field, in a company committed to developing first-rate platform capabilities. By enhancing our ability to manufacture rAAV vectors, our work will directly contribute to enabling gene therapies in broader and more challenging indications. The successful candidate will work across multiple projects, and should expect a fast-paced, dynamic environment.

Responsibilities:

  • Lead a team developing bioreactor-based cell culture processes for manufacturing of AAV gene therapy vectors across multiple preclinical programs and disease areas
  • Direct and execute PD experiments in shaken cultures and stirred-tank bioreactors from 2L-250L scale
  • Develop long-term PD platform strategy in collaboration with PD leadership, and Encoded’s CTO
  • Contribute to development of project-specific Control Strategy in support of GMP manufacturing and regulatory filings
  • Investigate new and alternative process technologies
  • Develop improved cell culture media and feed solutions
  • Optimize existing processes for improved consistency, performance, and product quality, including leadership of process characterization projects.
  • Serve as SME for scaleup and process transfer to manufacturing team; including scaledown experiments, authorship, and review of technical documents. May support MSAT investigations and external CMO manufacturing as-needed.
  • Serve as SME for upstream Process Characterization, including CQA risk assessment, DoE designs for optimization and CPP determination
  • Guide a team in planning and preparation for reliable execution of experiments and high-quality documentation
  • Contribute to expanding capabilities of Upstream PD lab, including identifying new equipment, external vendors, and/or improved workflows.
  • Lead certain process research initiatives and other projects, including cross-functional coordination including Downstream PD, Analytical Development, Research groups, and Technology team.

Requirements

  • PhD related to bioprocessing, biochemical engineering, or gene therapy and 8 or more years of industry experience designing and operating stirred-tank bioreactor experiments for mammalian cell culture OR
  • Master’s degree related to bioprocessing, biochemical engineering, or gene therapy and 10 or more years of industry experience designing and operating stirred-tank bioreactor experiments for mammalian cell culture
  • Ability to conceptualize and design long-term PD initiatives based on strategic objectives. Will guide and execute experiments, interpret data, present results, and mentor team members in these skills.
  • Experience supporting regulatory filings for IND/IMPD or commercialization, including working knowledge of regulatory guidance documents, and prior service on cross-functional CMC teams.
  • Detailed understanding of bioreactor control systems and relevant engineering concepts (PID control, kLa, etc.), and demonstrated ability to apply this knowledge toward process transfer, scaleup/scaledown, or troubleshooting.
  • Mathematical ability to perform engineering-based experiment design and data analysis, including skill with MS Excel, DoE, and/or other related tools.
  • Enthusiasm for collaborative work in a dynamic environment, plus individual accountability in areas of responsibility
  • Strong verbal and written skills are required, as well as effective interpersonal, technical, and troubleshooting skills

Preferred Qualifications:

  • Experience designing perfusion processes and/or development of medium and feed solutions
  • Experience with single-use bioreactors, AAV expression, large-scale transfection, and/or baculovirus TGE
  • Experience serving as PIP or other direct engagement with manufacturing groups
  • Prior exposure to large-scale GMP manufacturing either by direct experience, or from working in a PD or MSAT setting
  • Knowledge of DoE and JMP or DesignExpert
  • Experience with relevant database and visualization tools
  • Prior engagement in LIMS initiatives, and practical

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

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.

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Senior Research Associate / RA, Downstream Process Development

At Encoded, we are combining the precision of gene regulation with the versatility of gene therapies to create breakthrough treatments for individuals living with severe genetic diseases. We focus on delivering life-changing advances for individuals with genetic disorders not addressable with current approaches. Encoded Therapeutics is funded by world-class healthcare investors Venrock, Arch Venture Partners, Illumina Ventures, and Matrix Capital Management. For more information, please visit www.Encoded.com.

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 position of Senior Research Associate will assist the Downstream Process Development group at Encoded Therapeutics. A qualified candidate will be responsible for purification process development and support purification of our lead program at small and pilot scales. The ideal candidate will be hardworking, flexible and able to perform key responsibilities across multiple projects in a fast-paced and dynamic environment.

Responsibilities:

  • Purification and analytical techniques for AAV: chromatography, depth filtration, tangential flow-filtration, viral filtration, SEC, ELISA, SDS-PAGE, HPLC etc.
  • Bench scale development and characterization of purification techniques
  • Pilot scale execution of purification techniques
  • Meticulously maintain complete and accurate records of all work performed in an ELN
  • Author technical reports and SOPs
  • Analyze and interpret data
  • Tech Transfer activities
  • Level will be determined based on experience

Requirements

  • For the RA position, MS/BS in a chemical engineering, biochemical engineering, biochemistry or other relevant area and 1+/3+ years of industry experience in purification development or in a process development setting.
  • For the SRA position, MS/BS in a chemical engineering, biochemical engineering, biochemistry or other relevant area and 3+/5+ years of industry experience in purification development or in a process development setting.
  • Experience with AAV purification
  • Strong verbal and written communication skills as well as effective interpersonal skills
  • Technical discretion and troubleshooting skills
  • Team player, exhibiting a willingness to meet project timelines and multitask effectively
  • Proficient in Microsoft based Windows programs such as Excel, PowerPoint and Word.
  • Experience with AKTA Systems and UNICORN, statistical analysis, JMP, DOE, high throughput screening, coding, data management

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

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.

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Snr/Principal Scientist, Upstream Process Development/ rAAV Expression Tech.

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.

We are recruiting a Senior or Principal Scientist to lead the development of improved technologies for rAAV expression. This is a rare opportunity to enter an emerging field, in a company committed to developing first-rate platform capabilities. By enhancing our ability to manufacture rAAV vectors through cell line, plasmid and molecular engineering, our work will directly contribute to enabling gene therapies in broader and more challenging indications. The successful candidate will work across multiple projects, and should expect a fast-paced, dynamic environment.

Responsibilities:

  • Actualize vision of transformational improvements in rAAV manufacturing by creating cell line, plasmid and other relevant molecular technologies capable of supporting large market needs across a broad portfolio of therapeutic indications.
  • Develop and execute on long-term PD platform strategy in collaboration with PD leadership, and Encoded’s CTO
  • Investigate external technologies for rAAV expression, producer cell line/plasmid development, and build internal platform technologies where opportunities exist to advance beyond market offerings
  • Screening of genetic elements and design of next generation rAAV molecular expression systems and cell lines
  • Lead study of rAAV expression biology in collaboration with internal molecular biology and bioinformatics groups. May include oversight of NGS (Next Generation Sequencing) or CRISPR initiatives, proteomics, identification of novel approaches, and or validation of approaches from literature.
  • Manage Associates or Scientists in generation and small-scale evaluation of cell lines and expression systems. Will include close oversight of lab activities, with hands-on involvement in training and for non-standard operations.
  • May include approximately 10-20% remote work, with flexibility based on project needs and group development.
  • Collaborate with other Upstream PD sub-teams, Downstream PD, and Analytical Development groups for incorporation of promising technologies into clinical and commercial manufacturing processes. May include direction and/or handoff of workstreams for process optimization, integration with other PD initiatives, and for demonstration of scalability.
  • Establish procedures, training, and documentation suitable for generation of (non-GMP) cell banks suitable for GMP banking. May serve as SME advisor for external GMP cell bank manufacturing
  • Manage relationships with external partners, including contract research services, and non-GMP plasmid suppliers as applicable.
  • Guide a team in planning and preparation for reliable execution of experiments and high-quality documentation
  • Interface with vendor partners for planning and management of capital purchases, and indirect oversight of equipment maintenance.
  • May propose and/or develop novel analytical methods to support unique PD needs.
  • Advocate internally for investment in expression technologies and application of existing resources.
  • Generate intellectual property and contribute to FTO analysis and patent applications for process technologies

Requirements

  • PhD related to molecular biology, virology, immunology, or closely related discipline, and 8 or more years of industry experience.
  • Master’s degree related to molecular biology, virology, immunology, or closely related discipline and 14 or more years of industry experience
  • Ability to conceptualize and design long-term PD initiatives based on strategic objectives. Will guide and execute experiments, interpret data, present results, and mentor team members in these skills.
  • Experience designing and operating mammalian cell culture bioreactor experiments in a PD or MSAT setting
  • Experience with single-use bioreactors, AAV production, large-scale transfection, and/or baculovirus TGE are desired, but not needed
  • Ability to conceptualize and design research plans based on long-term platform objectives.
  • General knowledge of regulatory requirements for GMP manufacturing of biologics or gene therapy vectors
  • Mathematical ability to perform relevant data analysis and statistics, including skill with MS Excel.
  • Enthusiasm for collaborative work in a dynamic environment, plus individual accountability in areas of responsibility
  • Strong verbal and written skills are required, as well as effective interpersonal, technical, and troubleshooting skills

Preferred Qualifications:

  • Experience with rAAV expression, large-scale transfection, and/or baculovirus TGE
  • Working knowledge of conventional cell line development platforms, including FACS enrichment/cloning, minipool approaches, selection and screening approaches, clonality assessment & statistics, required controls & documentation for creation of GMP cell lines
  • Prior experience developing cell lines for virus, VLP, or vector expression
  • Prior experience writing cell line history reports, and/or preparing related sections of regulatory filings for either biologics or gene therapies
  • Basic understanding of bioreactor control systems and relevant engineering concepts (PID control, kLa, etc.), and ability to apply this knowledge toward scaleup/scaledown, or troubleshooting
  • Prior experience with IP generation and patent filings
  • Prior engagement in LIMS initiatives

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

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.

#LI-CL1

Lab Operations Coordinator – 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.

We are seeking a Lab Operations Coordinator that will serve to provide support for early stage gene therapy candidates. 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.

Responsibilities:

  • Ensure efficient operation of Process Development labs by providing and coordinating support activities
  • Reports to Manager, PD Pilot Team, with responsibility to support Cell Culture and Purification groups, including bench-scale studies up to 200 L scale production runs
  • Liaise with Supply Chain to ensure availability of specialty materials, and for effective management of stockroom program
  • Partner with Facilities and external vendors to ensure proper management of all aspects of laboratory equipment, including procurement, installation, calibration, maintenance, and alarm monitoring for critical equipment
  • Collaborate with EH&S on safety training, engineering controls, and waste management. May contribute to writing related Laboratory Procedures or manage review and approval workflow, in cooperation with QA.
  • Works cross-functionally to support continuous-improvement initiatives
  • Track departmental budget for laboratory supplies, equipment, and facility-related expenses.
  • Vendor management for sourcing and procurement of equipment and specialty materials, including obtaining proposals/price quotes, coordinating meetings with technical staff, managing contract & procurement workflows, and coordinating site-visits
  • Coordinate onboarding and training of new hires
  • Arrange non-GMP shipping for cell banks and process samples
  • May support readiness for laboratory studies, including ‘kitting’ supplies, preparation of buffers, sterile assemblies, sample manifests, labels, or batch documentation.
  • May assist verification of data transcription in study reports, manuscripts etc. as necessary.

Requirements

  • B.S in scientific field
  • 2-4 years of experience in biotechnology research, process development, pilot plant, or manufacturing, including 1-2 years with lab management or operations responsibilities
  • Strong organizational skills, and demonstrated ability to reliably manage multiple responsibilities.
  • Excellent interpersonal skills are required, with aptitude for interfacing across multiple technical and non-technical functions.

Preferred Qualifications:

  • B.S in biological sciences (Biology, Biotechnology, Bioengineering, Molecular Biology, Biochemistry or Cell Biology)
  • Familiarity with bioprocess manufacturing

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

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.

#LI-CL1