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Director Translational Biomarker Development will be an important member of the IND-enabling Sciences team, leader for the bioanalytical function, representative on program core teams, providing strategic inputs for assay development efforts to ensure rapid and high-quality execution of biochemical and molecular assay development/qualification and sample analysis to support PK/TK, metabolism, drug distribution, drug mechanism of action, PD and biomarkers, and immunogenicity assessments to advance HMI’s therapeutic platform.
We are seeking a highly motivated Associate Director with extensive knowledge and hands-on experience in downstream CMC to join our newly established Manufacturing Development & Technology (MD&T) group. The successful candidate will act as a technical lead in supporting downstream process transfer, scale-up, GMP manufacturing, and process validation for Homology’s novel and proprietary adeno-associated virus (AAV) viral vectors. The Associate Director is also expected to set-up the MD&T downstream lab and build a team to support process troubleshooting and investigations for internal and external manufacturing. The ideal candidate needs to be a strong technical leader, that contributes actively to both process development and GMP manufacturing.
We are seeking a highly motivated Senior Process Engineer I with outstanding knowledge and hands-on experience in downstream process development and process scale-up. This individual will be responsible for providing technical and scientific expertise to downstream process transfer, scale-up, and GMP manufacturing for Homology’s novel and proprietary adeno-associated virus (AAV) viral vectors. Critical to this role, is the ability to effectively communicate scientific findings and innovative solutions with other functions including Process Development, Manufacturing, Engineering, Quality and CMC teams.
Homology Medicines is seeking an outstanding Senior Scientist to assist in the advancement of Homology’s viral gene therapy production platform. Homology has a portfolio of 15 unique adeno-associated viruses, called AAVHSC’s, and is well on its way to developing large scale rare disease cures. The individual in this role will be a highly-skilled, talented and motivated researcher who will lead the work to develop and characterize next generation plasmids for large scale manufacturing of AAV vectors. We seek candidates with proven ability to work independently and collaboratively, who are driven to pursue cutting edge science and develop next generation therapies to transform the lives of patients, and most importantly who are passionate about great science & a positive culture.
We are seeking a highly motivated Associate Director with extensive knowledge and hands-on experience in upstream CMC to join our newly established Manufacturing Development & Technology (MD&T) group. The successful candidate will act as a technical lead in supporting upstream process transfer, scale-up, GMP manufacturing, and process validation for Homology’s novel and proprietary adeno-associated virus (AAV) viral vectors. The Associate Director is also expected to set-up the MD&T upstream lab and build a team to support process troubleshooting and investigations for internal and external manufacturing. The ideal candidate needs to be a strong technical leader, that contributes actively to both process development and GMP manufacturing.
Homology is searching for a Senior GMP Manufacturing Technician to be a member of our Manufacturing Operations team. This person will participate in the start-up and operation of a new phase I/II cGMP manufacturing facility. They will execute the routine operation of gene therapy production equipment, including but not limited to bioreactors, chromatography systems, ultrafiltration, media preparation, buffer preparation, raw material weigh/dispense, and solution filtration. This person will assist in the shakedown and qualification of manufacturing equipment and spaces. They will author manufacturing SOP’s, log sheets, and batch records. They will assist in the review of competed manufacturing documents such as forms, log sheets, and batch records. They will assist with the scheduling of manufacturing and qualification activities. This person will assist in the training of less experienced manufacturing technicians, and lead operational teams. They will maintain material and component inventory levels in the manufacturing areas, as well as assist in area upkeep. Work will be performed in a clean room environment, in accordance to Good Manufacturing Practices, standard operating procedures, and batch records. The incumbent must be detail oriented, and be able to read and execute written instructions with precision. Strong written and verbal communication skills are required. The ideal candidate is creative and team oriented, with a high level of integrity and initiative.
Homology Medicines is seeking a Research Associate to aid in operational support for methods to characterize AAV vector products. The individual in this role will be a talented and motivated technician who will focus on the analysis of research/development-grade vector samples using multiple AAV-specific analytical methods. This is a largely laboratory-based position with a focus on providing analytical support for characterizing research-grade vectors.
The Business Development professional will be leveraging a broad base of prior pharmaceutical/ biotech industry experience, a high attention to detail, advanced analytical skills, and experience structuring complex licensing collaborations and acquisitions, as well as will assume a key role in a business-critical function that directly impacts our therapeutic goals and objectives. Homology’s business strategy is to develop and commercialize a broad pipeline of gene therapies. This position Business Development has been and will continue to be an integral part of our short- and long-term growth strategy. We expect to enter into additional collaboration and licensing agreements as a means of obtaining resources, capabilities and funding to advance our gene therapy programs and to further grow our business.
Homology Medicines seeks an outstanding science in the upstream process development group to assist in the development of viral manufacturing processes. The individual in this role will be a highly motivated scientist with experience in bioreactor cell culture production processes who will focus on the development and scale up of cell-based methods for producing AAV vectors. We seek candidates with proven ability to work independently after initial training and collaboratively to achieve optimized project plans, with the goal to deliver products that transform the lives of patients.
Homology Medicine's is currently searching for an experienced Director, Procurement & Strategic Sourcing to manage the company’s procurement strategy and processes with an emphasis on GMP and R&D materials. This individual will have the ability to build the Procurement function and collaborate cross-functionally within our growing organization. The overall responsibilities include developing strategic initiatives and processes to deliver optimal value support and services. Ideal candidate will have strong communication and organizational skills as well as ability to build strong relationships internally and externally with vendors/partners. Scope of function will cover both strategic development as well as tactical support, and everything in between to help ensure success.
The selected individual will lead the development of IT infrastructure at Homology Medicines, Inc. This individual will work closely with the Leadership Team to create and implement robust IT plans and strategies, track progress against key milestones and program goals, and ensure effective communication across all internal stakeholders. Experience working with cross-functional teams is required. Knowledge of IT systems requirements in a GXP regulate environment. This individual will be responsible for the architectural design and development of hardware, software, and networking systems. Provides an architectural framework for system development, maintenance, and enhancement efforts. Analyzes systems and performs usability testing to ensure performance and reliability, enhance scalability, and meet security requirements. Scope of work includes the management of databases and HMI’s global networking infrastructure.
Homology Medicines is seeking a Senior Clinical Data Manager to join our Clinical Operations team. This is a newly created role and will report directly to Head of Clinical Operations. The selected applicant will be responsible for independently leading Data Management aspects of a clinical study. The Senior Clinical Data Manager has thorough knowledge of FDA regulations and industry standards, strong technical skills and can work collaboratively with vendors to assure that Data Management functions are performed in compliance with regulations and according to study protocol.