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Senior/ Director of Biology, Rare Genetic Disorders

Employer
Orna Therapeutics
Location
MA, Massachusetts, US
Salary
Competitive
Closing date
Jul 12, 2022

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Sector
Academic / Research
Field
Informatics / GIS
Discipline
Project Management, Biology
Salary Type
Salary
Employment Type
Full time
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Here at Orna, we believe in the limitless potential of not only our technology but of our team. Comprised of a dedicated, unique group of individuals, we want you to join us in our mission to change the way we treat disease.

We close the loop between science
and patients - our true impact
comes only upon success.

A circle has no limits - we push
beyond obstacles to discover new
ideas and new answers to the
challenges of meeting patient need.

Our sphere of impact extends
beyond ourselves to patients, friends,
family, neighbors, the community. We
never lose hope for a better tomorrow.

Every arc is profoundly similar yet
completely unique. Our circle of
collaboration and teamwork encloses a
safe space where we listen deeply, speak
openly, and honestly share perspectives.

We go all in. We work hard,
we have fun, we deliver on our
promises and achieve results. We
inspire each other to be our best.
Committed to Diversity, Equity, and Inclusion
We believe in the infinite power of belonging. We cultivate a culture where people feel safe, included, and heard. Our team of Ornacorns is reflective of the diversity in the world. Here, we can be our whole selves, so we reach our full potential.

Each member of our team is rare and unique, similar to a unicorn, making Orna a magical place to work!
Hear what some of our "Ornacorns" have to say about why Orna is the place to be:

"

One of the best things about Orna is the people. Everyone is accepted, valued and encouraged to grow.
"
"

Orna gives me the opportunity to work at the technological forefront of RNA therapeutics in a fun, exciting, team-oriented environment.
"
- Corey Ciullo, Senior Scientist

"

I love how the fast paced nature of work constantly provides learning opportunities while trying new things. I'm truly inspired to ask questions and creatively solve problems being surrounded by so many smart and ambitious individuals who I can also call my friends when the going gets tough.
" Interested in joining our team?
Together, we continue to think outside the lines, pushing the boundaries of what's possible when it comes to treating disease. If you're ready to join our talented group of people with just the right amount of quirk, check out our current job openings below and send your resume to talent@ornatx.com .

Please note that Orna partners with select organizations to recruit talent. To avoid scams targeting our candidates, correspondence from our recruiting team will only come fromtalent@ornatx.com or other@ornatx.comaddresses. Our recruiting team and any recruiting agencies with whom Orna partners do not ask candidates to provide sensitive information via email and do not conduct interviews using telegram, WhatsApp, or text messaging.

External Manufacturing and Supply Chain Lead

Orna Therapeutics, Inc. is a Cambridge-based biotechnology startup on a mission to create therapies for diseases inaccessible to existing approaches. Built on novel circular RNA technology developed at MIT, Orna is leading the next wave of RNA therapeutics with our best-in-class expression and delivery platform. We are seeking an exceptional External Manufacturing and Supply Chain Lead to join our team. The candidate will manage supply chain and external manufacturing activities for Orna's circular RNA and lipid nanoparticle candidates. Primary responsibilities include working with internal stakeholders and third-party partners to plan external manufacturing and supply chain activities, ensuring timely delivery of of materials and coordination of CRO services, and acting as the primary liaison with external suppliers, logistics providers, and test/manufacturing partners. The ideal candidate will have extensive experience working with a variety of CDMOs for cell and gene therapy or nanoparticle applications and working with internal R&D, CMC and other teams. Furthermore, the candidate will possess strong oral and written communication capabilities, demonstrate excellent organization, collaboration, and interpersonal skills, and be adept at problem solving in a fast-paced environment.

Responsibilities
  • Work closely with the SVP, CMC and other team members to develop, support and facilitate a comprehensive supply chain and manufacturing strategy for Orna's circular RNA and lipid nanoparticle candidates.
  • Help identify, engage, and manage relationships with vendors and external manufacturing/testing partners.
  • Be responsible for all logistics regarding procurement, release, testing, storage, and shipping of raw materials, Drug Substance, and Drug Product.
  • Help oversee manufacturing and testing activities at CDMO partners, including non-GMP and GMP activities, for circular RNA and lipid nanoparticle candidates.
  • Resolve any issues impacting timelines or other critical deliverables, communicate potential impact(s) to management and other key stakeholders, and assist in mitigation plans.
  • Work with CMC leadership and SMEs to ensure adequate support for technology transfer and process development at 3 rd parties, where applicable.
  • Work with CMC and QA functions to coordinate release and shipment of test article(s) for preclinical/GLP studies and investigational products for clinical studies.
  • Work with QA and other stakeholders to review data, interpret results, and address Quality issues, e.g. CAPAs, OOS, OOT, deviations/investigations, etc., that might arise.
  • Contribute to regulatory filings as needed.
  • Contribute to a positive and exciting work environment; contribute to a strong entrepreneurial and creative culture.

Orna Therapeutics, Inc. is an equal opportunity employer.
  • 7+ years of experience in managing supply chain(s) and external manufacturing activities in a GxP environment. Significant experience working with new process development and/or pharmaceutical manufacturing technologies.
  • Significant familiarity with GMP/GCP/GLP environments, technology transfer, and establishing logistics processes and inventories.
  • Experience with nucleic acid products, nanoparticles, large molecules or new modalities preferred.
  • Ability to interpret and troubleshoot data, with excellent problem-solving skills.
  • Experience working productively with small and medium-sized teams.
  • Experience working with cross-functional product development teams, including Research & Development, QA, Pre-clinical and Safety, Regulatory Affairs, and other groups.
  • Highly organized and can collaborate on execution of multiple parallel initiatives.
  • Detail oriented, self-motivated, and excited to take on new challenges!

Orna Therapeutics, Inc. is a Cambridge-based biotechnology startup on a mission to create therapies for diseases inaccessible to existing approaches. Built on novel circular RNA technology developed at MIT, Orna is leading the next wave of RNA therapeutics with our best-in-class expression and delivery platform. We are seeking an exceptional Director, Pharmaceutical Development to join our team. The candidate will report to the SVP, CMC and work cross-functionally to lead key product development activities for Orna's products. Specific responsibilities include contributing to Orna's overall pharmaceutical development strategy, leading internal analytical and drug product development teams, and authoring/contributing to applicable sections of regulatory filings. The ideal candidate will have significant experience in early-stage product development (preclinical to Phase 2) for complex pharmaceutical products, including experience developing and evaluating suspension formulations and selecting appropriate container closure systems for clinical-stage products. They will be able to quickly develop and implement phase-appropriate product development solutions, demonstrate excellent collaboration and interpersonal skills, and be adept at problem solving in a fast-paced environment.

Responsibilities
  • Lead analytical and formulation functions and ensure robust cross-functional collaboration.
  • Collaborate closely with senior management and internal SMEs to develop formulation and analytical development strategies for Orna's circular RNA products.
  • Manage a team of cross-functional direct reports across analytical development and formulation development functions. Collaborate closely with peer groups in process development, supply chain, and QA.
  • Oversee implementation formulation and analytical development activities to support broader product development.
  • Manage external CRO/CDMO partners and oversee tech transfer activities, where appropriate.
  • Generate, interpret, and present data to cross-functional R&D teams.
  • Author/review analytical and pharmaceutical development sections of regulatory filings.
  • Contribute to a positive and exciting work environment; contribute to a strong entrepreneurial and creative culture.

Orna Therapeutics, Inc. is an equal opportunity employer.
  • PhD+ 10 years pharmaceutical or biotechnology experience, MS+15 years industry experience or equivalent in chemistry, molecular biology, biochemistry, engineering, or related field.
  • 10+ years of experience in pharmaceutical development, including experience developing critical quality attributes and quality target product profiles for new technologies or new therapeutic modalities.
  • Experience with nanoparticles and/or complex particle products preferred.
  • Experience leading department-level teams in analytical and/or formulation development.
  • Broad familiarity with cross-functional pharmaceutical development activities, with a track-record of developing clinical-stage products in multi-functional teams (Research and Development, Preclinical, Safety, Clinical).
  • Experience authoring regulatory documents.
  • Highly organized and can collaborate on execution of multiple parallel initiatives.
  • Detail oriented, self-motivated, and excited to take on new challenges!
Senior Scientist, Machine Learning RNA Biology
Orna is a Cambridge-based biotechnology startup on a mission to create therapies for diseases inaccessible to existing approaches. Built on novel circular RNA technology developed at MIT, Orna is leading the next wave of RNA therapeutics with our best-in-class expression and delivery platform.

We are seeking an exceptional Machine Learning Scientist to gain insight into RNA sequence, structure, and function and advance our high throughput discovery platform. The ideal candidate has a PhD in Computer Science/Computational Biology/Bioinformatics or a related field, preferably with application in RNA Molecular Biology. They should possess strong oral and written communication capabilities, demonstrate excellent collaboration and interpersonal skills, and be adept at problem solving in a fast-paced environment.

Responsibilities
  • Train, optimize, and evaluate machine learning models to enhance oRNA design.
  • Use model interpretation tools to shape experimental strategies that leverage NGS related approaches.
  • Work with RNA biologists and bioengineers to acquire datasets to improve the performance of our machine learning models.
  • Develop and maintain version-controlled code with software best practices.
  • Aid in processing, analyzing, and interpreting high dimensional NGS data.
  • Effectively communicate technical information to both technical and non-technical collaborators. Identify core challenges, evaluate tradeoffs, and incorporate feedback to make decisions.
  • Mentor associates and engineers.

Orna Therapeutics, Inc. is an equal opportunity employer.
  • PhD in Computer Science, Computational Biology, Bioinformatics or a related field, preferably, with application in RNA Molecular Biology (exceptional non-PhD scientists are welcome to apply!).
  • Minimum of 3 years' research experience in developing machine learning models for molecular biology applications.
  • Working knowledge in designing, evaluating and tuning CNNs, RNNs and MPNNs(GNNs) and VAEs as well as shallow tree-based models.
  • Comfort with semantic/neural representations of biological sequences.
  • Experience working with Machine Learning frameworks such as Tensorflow, PyTorch, JAX, sklearn.
  • Experience in Python/R programming, UNIX command line, bioinformatic toolkits, and version control systems (e.g. git).
  • Demonstrated quantitative and scientific thinking as evidenced by a strong publication record.
  • Goal-oriented and organized with excellent project management skills. Can collaborate on execution of multiple, parallel studies with internal and external partners. Able to prioritize and complete tasks in a timely manner.

Preferred Skills
  • Foundational understanding in RNA biology and biochemistry.
  • Familiarity with RNA secondary structure prediction tools such as RNAStructure, RNAFold, or Eternafold, Locarna etc is strongly preferred.
  • Experience analyzing data from SHAPE-Map, DMS-Map, Ribo-seq, Mutate and map experiments
  • Familiarity with model interpretation tools such as SHAP, LIME etc.
  • Hands-on experience using Amazon Web Services.
In vivo Senior Research Associate - Genetic Diseases
Orna is a venture-backed, Cambridge-based startup creating a pipeline of RNA-based therapies based on technology developed at MIT. Our mission is to address diseases not accessible by existing approaches with our best-in-class proprietary RNA expression and delivery platform. We are seeking an exceptional researcher to join our team as a Senior Research Associate to evaluate candidate therapies for the treatment of genetic diseases. The ideal candidate has at least a bachelor's degree in a biology-related field with relevant in vivo laboratory experience. They will be able to quickly learn and integrate new protocols into existing workflows, possess strong oral and written communication capabilities, demonstrate excellent collaboration and interpersonal skills, and be adept at problem solving in a fast-paced environment.

Responsibilities
  • Expand Orna's therapeutic pipeline through evaluation of RNA encapsulated nanoparticle formulations in relevant animal models.
  • Support design and execution of studies in relevant animal disease models.
  • Collaborate with technical support services to facilitate study execution.
  • Ability to solve technical problems in a practical and rational manner.
  • Prepare tissue collection materials and documents related to in vivo studies.
  • Effectively communicate experimental plans and data; present to cross-functional R&D teams.
  • Maintain an up-to-date and accurate electronic notebook record of performed studies.
  • Self-motivated, detail oriented, and able to effectively manage time to execute multiple parallel laboratory and in vivo activities.
  • Contribute to a positive and exciting work environment; contribute to a strong entrepreneurial and creative culture.

Orna Therapeutics, Inc. is an equal opportunity employer.
  • BS in biology, cellular biology, genetics, biochemistry, or related discipline with 3+ years of relevant in vivo experience.
  • Significant hands-on experience with animal handling, anesthesia, and dosing (IV, IM) methods according to humane practices.
  • Perform full necropsy and collection of tissues and blood , for downstream processing including protein isolation; Experience with related-molecular biology techniques such as Western Blotting or qPCR a plus.
  • Highly organized individual that can manage the execution of multiple, parallel in vivo studies occurring at internal and external research facilities.
  • Detail oriented and self-motivated, willingness to take on new challenges.
  • Effective written and oral communication skills with experience working in cross-functional teams.
Research Associate/Senior Research Associate - Analytical Research & Development
Orna is a venture-backed, Cambridge-based startup creating a pipeline of RNA-based therapies based on technology developed at MIT. Our mission is to address diseases not accessible by existing approaches with our best-in-class proprietary RNA expression and delivery platform. We are seeking an exceptional RA/SRA, Analytical R&D to join our team. The position will work closely with platform science, biology, and CMC teams for characterization of Orna's circular RNA and nanoparticle products. The ideal candidate would have at least a bachelor's degree in a biology-related field with relevant ELISA, qPCR, and other bioanalytical assays experience. They will be able to quickly learn and follow processing protocols, possess strong oral and written communication capabilities, demonstrate excellent collaboration and interpersonal skills, and be adept at problem solving in a fast-paced environment.

Responsibilities
  • Implement Orna's analytical testing strategy for circular RNA and lipid nanoparticle formulations.
  • Develop and qualify drug substance and drug product bioanalytical assays and perform characterization studies on lead development and pipeline candidates.
  • Work with external CRO/CDMO partners to achieve specific deliverables.
  • Generate, interpret, and present data to cross-functional R&D teams.
  • Contribute to a positive and exciting work environment; contribute to a strong entrepreneurial and creative culture.

Orna Therapeutics, Inc. is an equal opportunity employer.
  • BS + 2 years industry experience or equivalent in chemistry, molecular biology, biochemistry, engineering, or related field.
  • Experience developing bioanalytical methods for pharmaceutical products. Experience with biomolecules, nucleic acid therapeutics and/or nanoparticles preferred.
  • Experience interfacing with cross-functional colleagues preferred.
  • Highly organized and can collaborate on execution of multiple parallel initiatives.
  • Detail oriented, self-motivated, and excited to take on new challenges!
Senior Associate Scientist/Scientist, Production - Process Development
Orna is a Cambridge-based biotechnology startup on a mission to create therapies for diseases inaccessible to existing approaches. Built on novel circular RNA technology developed at MIT, Orna is leading the next wave of RNA therapeutics with our best-in-class expression and delivery platform. We are seeking an exceptional scientist to join our RNA production and early process development team as a Sr Associate Scientist/Scientist. The successful candidate will work with cross-functional teams to advance our oRNA™ platform through rigorous process development. This candidate is a well-organized, team-oriented scientist with in-depth knowledge and hands-on experience in in vitro transcription reactions, nucleic acid purification and/or analytical method development for the characterization of long RNAs. They possess exceptional written and oral communication capabilities, demonstrate excellent collaboration and interpersonal skills, and are adept at problem solving in a fast-paced environment.

Responsibilities
  • Develop and execute detailed data-driven process development plans using scientifically sound methodology, including design-of-experiments approaches.
  • Work with the oRNA production team to integrate and implement validated processes/procedures into existing workflows.
  • Contribute to or lead evaluation of scalable methodologies and approaches to produce and purify oRNA and tech transfer to the CMC team.
  • Generate, interpret, and present process development data to cross-functional R&D teams and may contribute to our overall IP efforts.
  • Contribute to oRNA productions to enable advancement of therapeutic programs and platform projects.
  • Contribute to a positive and exciting work environment; contribute to a strong entrepreneurial and creative culture.

Orna Therapeutics, Inc. is an equal opportunity employer.
  • Ph.D. in molecular biology, chemical engineering or related field with 0-3 years relevant industry experience, BS/MS with ≥ 6 years relevant industry experience.
  • In-depth knowledge of RNA biology and experience in process development of RNA synthesis in a biopharmaceutical context required.
  • Experience with nucleic acid production using in vitro transcription required.
  • Proven track record of productively working with cross-functional teams.
  • Hands-on experience with diverse chromatographic methodologies for nucleic acid separation is highly desired.
  • Strong communication and collaborative instinct with good time and resource management skills.
  • Highly organized and can collaborate on execution of multiple parallel initiatives.
  • Detail oriented, organized, self-motivated, and excited to take on new challenges!

Orna Therapeutics, Inc. is a Cambridge-based biotechnology startup on a mission to create therapies for diseases inaccessible to existing approaches. Built on novel circular RNA technology developed at MIT, Orna is leading the next wave of RNA therapeutics with our best-in-class expression and delivery platform. We are seeking an exceptional Document Control Manager to join our team. The ideal candidate will have experience with the management of GxP internal/external documentation, training program and additional functional activities. They must have a working knowledge of QMS and its responsibilities and be a self-starting problem solver who drives results through high compliance and a positive work style ensuring quality activities are carried out according to the regulatory requirements.

Responsibilities
  • Ensure quality activities are carried out according to the regulatory requirements and/or the internal QMS.
  • Drive Document Management System tasks to completion.
  • Assist in the execution of other QMS responsibilities as needed (i.e., CAPA, Change Control, Quality Events, etc.)
  • Assist in facilitating and conducting trainings related to the electronic document management system in coordination with QA/GxP Training.
  • Editing documents for consistent formatting and working with content owners to ensure quality document.
  • Coordinate workflows with task owners to ensure that documents are properly reviewed, issued, approved, and obsoleted within needed timeframes.
  • Follow up with others to ensure that records are completed and documented within established timeframes.
  • Execute Administrative tasks for Veeva Quality Vault or equivalent EDMS system including but not limited to user provisioning and periodic system updates/maintenance.
  • Be a self-starting problem solver who drives results through high compliance and a positive work style.
  • Additional responsibility for execution and maintenance (data entry, metric reporting, filing, archival) of assigned quality system.
  • Performs related duties as required.

Orna Therapeutics, Inc. is an equal opportunity employer.
  • Bachelor's degree or equivalent experience.
  • At least 3 years of experience in the pharmaceutical/biotech industry. 7+ years of document management experience in a Quality Assurance related function.
  • Must have excellent abilities with intermediate MS office concepts such as Word Styles, cross-references, keep with next, section breaks, freeze panes, header/footer, and others.
  • Experience with Veeva Vault or other electronic document and quality management system is preferred.
  • Knowledge of GLP, GMP, GCP, Part 11 regulations, FDA Guidances for Industry, EU regulations, and other standards.
  • Strong proofreading and document formatting skills which must include processing of controlled documents (new documents, revision, obsolescence, etc.)
  • Strong problem solving/analytical skills.
  • Ability to work independently with minimal supervision, interact with staff (at all levels) in a fast-paced environment, sometimes under pressure, remaining flexible, proactive, resourceful and efficient, with a high level of professionalism.
  • Excellent written and verbal communication skills, strong organizational skills, strong negotiation, analytical and decision-making skills, and attention to detail
  • The ability to comprehend regulations and guidance documents and apply critical thinking skills to evaluate requirements and effectively communicate written and oral findings.
  • Strong organizational skills, with the ability to handle multiple tasks.

Orna is a Cambridge-based biotechnology startup on a mission to create therapies for diseases inaccessible to existing approaches. Built on novel circular RNA technology developed at MIT, Orna is leading the next wave of RNA therapeutics with our best-in-class expression and delivery platform. We are seeking an exceptional leader to join our Molecular Biology team as an Associate Director to drive Orna's Platform Expansion group and apply creative sequence engineering principles to further the development of our oRNA platform. The ideal candidate is an RNA technologist with strong scientific intuition and expertise in synthetic long RNA design, cell biology, and molecular biology. The candidate has a Ph.D. in molecular biology or a related field with substantial relevant experience in the pharmaceutical or biotech industry. They will be able to apply their experience to lead the rational design of novel oRNAs using both synthetic sequence elements and components from nature, interrogate the cell biology of oRNA, and investigate new applications for the oRNA platform. They will demonstrate excellent interpersonal skills, have significant management experience, and thrive in a fast-paced environment.

Responsibilities
  • Lead the molecular biology Platform Expansion team in the design and assessment of novel synthetic oRNAs to maximize circularization efficiency, expression, and stability.
  • Assess the immunotoxicity of different oRNA preparations in key cell and animal models.
  • Explore new applications for the oRNA technology, particularly as they relate to human health and disease, and lead proof of concept studies.
  • Identify talent to grow the Platform Expansion team; foster collaborative relationships across the team and company and engage in a positive and exciting work environment.
  • Contribute to patent applications and publications.
  • Manage projects, goals, and timelines within the Platform Expansion team; communicate findings in a variety of forums across the company.

Orna Therapeutics, Inc. is an equal opportunity employer.
  • PhD in molecular biology or related field with at least 6 years of industry experience is required.
  • Prior people management and project management experience is required.
  • Broad knowledge of RNA sequence and structure principles, RNA innate immunology, translation initiation mechanisms, splicing, RNA modifications, and cellular RNA metabolism is required.
  • Experience working with synthetic long RNA is required.
  • Hands-on experience engineering RNA molecules for various purposes is strongly preferred.
  • Experience in using cutting edge technologies to investigate RNA structure and function as illustrated by strong publication record and/or IP applications.
  • Demonstrated managerial experience with emphasis on resource/timeline management to meet team goals.
  • Proven track record of collaboration and positive influence across the organization at all levels.
  • Demonstrated ability to present complex technical topics to a wide range of audiences with varying technical depth.
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