Contract
Senior Specialist
Quality Control, Contract
Posted on 10/1/2025
Orbital Therapeutics
11-50 employees
RNA-based medicines development and delivery platform
No salary listed
Cambridge, MA, USA
Hybrid
 QA & Testing (5) |
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- Bachelor's degree required, preferably in a chemistry, life science, or related discipline with 5+ years relevant experience
- Past experience with quality control, preferably with focus on stability
- Hands-on experience on with at least one of the following analyses: mRNA, LNP, Potency assay, Flow Cytometry, PCR, ELISA, and/or HPLC is required
- Good understanding with cGMP, GDP and GLP regulations and guidelines
- General experience in data analysis and statistical evaluation/data trending
- Scientific knowledge and direct experience with analytical method transfer processes
- Advanced technical writing skills and problem-solving ability
- Ability to work independently in a high-paced team environment, meet deadlines, and prioritize work from multiple projects
- Communicate effectively with peers, and demonstrate collaboration across different functional groups
- Detail-oriented in assay execution and documentation
- The person will serve as a Subject Matter Expert (SME) in the quality control group and will work along with analytical development team on method transfers from internal analytical team to external CDMO QC group
- The workstreams include technical GMP lead for oversight of external release and stability testing, method transfer troubleshooting, assisting in critical reagent management, execution of technical protocols
- Oversight of method qualification, validation at CDMO QC laboratories
- Support stability data analysis along with stability document reviews
- Maintain stability sample inventory and perform stability sample shipments to external contract laboratories and/or sample storage vendors, if needed
- Work with QA group on datasheet review, QC investigation, out of specification (OOS), CAPA, Change Controls, and/or Deviation reports
- Independently develop, author, revise, and execute SOPs, protocols, reports, and other related documents
- Perform internal stability testing for RNA related testing samples and formulated drug product samples, including compendial methods along with biophysical testing such as particle size, LNP encapsulation, etc.
- Support routine analytical testing for research program needs, such as with chromatography-based methods (HPLC) and/or biochemical assays such as ELISA assay
- Prepare the data packet for review and peer-review the data
- Experience with developing and implementing QC related systems and CAPA tracking
- Experience with external QC for GMP or CGMP facilities
- Experience with stability programs, stability indicating methods, and stability protocols
- Experience with GMP or GLP documentation and audits
- Experience with tech transfer
- Familiarity with analytical software and data visualization tools
Orbital Therapeutics creates RNA-based medicines (not including siRNA) and builds a platform that combines RNA design, delivery methods, data science, and automation to develop a wide range of therapies. Its initial focus areas are vaccines, immunomodulation, and protein replacement. The company develops and commercializes RNA medicines, selling them to healthcare providers who administer treatment to patients. It differentiates itself through an integrated platform that merges RNA technology with delivery and automated data-driven workflows to accelerate discovery and development. Led by experts in genetic medicine, including Dr. Giuseppe Ciaramella, the team leverages deep experience in antivirals, immunology, and biotherapeutics to guide research. The goal is to improve global health by making RNA medicines accessible for diseases previously difficult to treat.
Company Size
11-50
Company Stage
Acquired
Total Funding
$1.8B
Headquarters
San Francisco, California
Founded
2022
Simplify's Take
What believers are saying
- Bristol Myers Squibb acquires Orbital for $1.5 billion, validating platform.
- OTX-201 shows full B cell depletion in non-human primates per July 2025 data.
- Plans IND filing and clinical trials for OTX-201 in first half 2026.
What critics are saying
- OTX-201 fails Phase 1/2 trials due to human efficacy mismatches in 18-36 months.
- BMS integration causes CEO Ron Philip departure, disrupting expertise in 12-24 months.
- FDA delays OTX-201 IND beyond H1 2026 over circular RNA regulatory uncertainty.
What makes Orbital Therapeutics unique
- Orbital pioneers circular RNA for in vivo CAR-T therapy OTX-201 targeting CD19.
- Platform integrates RNA design, targeted LNPs, and AI for immune reprogramming.
- Focuses on autoimmune diseases via B cell depletion and immune reset.
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Growth & Insights and Company News
6 month growth
↓ -9%1 year growth
↑ 15%2 year growth
↑ 20%Acquisition includes OTX-201, an investigational next-generation CAR T-cell therapy designed to reprogram cells in vivo with potential best-in-class profile for autoimmune diseases Transaction further strengthens BMS’s industry-leading cell therapy portfolio, expanding CAR T-cell access to more patients in the future Bristol Myers Squibb (NYSE: BMY, “BMS”) and Orbital Therapeutics (“Orbital”) today announced a definitive agreement under which BMS will acquire Orbital, a privately held biotechnology company pioneering a new generation of RNA medicines that reprogram the immune system in vivo , enabling treatments that provide the precision, control, and flexibility needed to address the underlying biology and unique complexities of each disease. “ In vivo CAR T represents a novel treatment approach that could redefine how we treat autoimmune diseases,” said Robert Plenge, MD, PhD, executive vice president, Chief Research Officer, BMS. “This acquisition enhances our robust cell therapy
International law firm Covington & Burling LLP has advised multinational biopharmaceutical company Bristol Myers Squibb in its definitive agreement to acquire biotech company Orbital Therapeutics.
"Since inception, Orbital has made significant strides developing a differentiated RNA platform designed to enable a new generation of RNA medicines that reach more tissues, address more diseases, and benefit more patients.
Orbital Therapeutics, a biotechnology company pioneering a new generation of RNA medicines that reprogramme the immune system in vivo to treat disease at its source, have appointed Adam Raff, as Senior Vice President, Clinical Development.
Orbital is developing OTX-201 for B cell-driven autoimmune diseases, where the therapeutic goal is to deplete autoreactive B cells and reset the immune system.