Job details
Job type full-time
Full job description
Full time position – remote
Company summary
Sio gene therapies is a biopharmaceutical company committed to developing treatments for cns diseasesThe company has rapidly built a diverse portfolio of gene therapy candidates with the potential to address debilitating genetic cns diseases for which the unmet medical need is high, the biology for treatment is clear, and for which there are no approved therapiesAdditionally, the company is focused on more common debilitating cns diseases, such as parkinson’s disease.
Developing new genetic treatments for these diseases is challenging workIt takes courage, talent, and dedication to look past the easy answers and uncover new solutions that can make a meaningful impactAt sio, we push each other to perform at our very best to make a difference in our patients’ lives.
Overall summary
Sio gene therapies is seeking a highly motivated manager/senior manager, quality control, to support our gene therapy programReporting to the associate director, analytical development and quality control, the manager/senior manager, quality control will be responsible for organization, management, and tracking of testing related to lvv and aav-based gene therapy programs, including document management and data trending.
Primary responsibilities
Support the implementation of phase-appropriate testing strategies for viral gene therapy vectors.
Liaise with contract testing organizations performing assay development as well as product release testing.
Managing and reviewing controlled documentation related to qc testing.
Support technical transfer between laboratories, qualification/validation of assays and qc activities for material release.
Managing and tracking the performance of stability programs for gene therapy products.
Management, trending, and organization of analytical data for presentation and to inform decisions.
Coordination with internal and external parties, including program management, process development, manufacturing, supply chain, quality assurance, regulatory affairs and clinical operations.
Identification and communication of risks in assay performance and their mitigation.
Responsibility to develop, author, review, and/or approve standard operating procedures, specifications, regulatory filings, or other controlled documents as needed.
Desired skills and experiences
B.sIn chemistry, biological sciences, engineering, or related discipline with 8+ years of experience; m.s with 6+ years of experience; ph.dWith 3+ years of experience preferred.
Expertise in gene therapy projects desired.
Working knowledge of analytical technologies employed in gene therapy (ddpcr/qpcr, hplc, lc/ms, cell-based assays, elisa, among others).
Experience managing, trending, and analyzing analytical data is essential.
Familiarity with assay development, qualification, and validation activities is essential.
Expertise in quality control, preferably in late stage/commercial pharmaceutical projects.
Experience managing contract organizations.
Expertise in efficiently interacting with quality assurance and regulatory affairs.
Occasional travel to contract organizations required.
Familiarity with regulatory requirement for testing of viral gene therapy products.
Excellent written and verbal communication skills, good interpersonal and management skills to collaborate with and direct the work of others on assigned projects (including both internal teams and external collaborators).
Results oriented, has a bias for actionStrong initiative, accountability, and willingness to take ownership and drive projects to completion.
Accustomed to “rolling up their sleeves” and executing the ever-changing tasks needed in a small company environment.
Ability to set priorities, work independently and deliver results in a timely mannerDisplay a sense of urgency.
Remote work location possible
This is an exciting time to join the field of gene therapy in general, and to become a part of sio gene therapies’ fast-growing dedicated teamSio gene therapies is a publicly traded companyWe offer an exciting, meaningful, and collaborative fast-paced environment with a foundation of sound and rigorous scienceCompetitive compensation and benefits package can be expected.
Interested applicants should send a cover letter and resume to: hr@siogtx.com
