The Scientist will design experiments, driven to support assay development. You will bring your expertise to a scientific team working on gene therapy by developing state-of-the-art therapies for the treatment of rare inherited diseases. Our research is in the field of ex vivo lentiviral vector gene transfer into hematopoietic stem/progenitor cells with a mission of curing lysosomal storage disorders and rare diseases in one dose. You will assist in all aspects of research to test gene therapy vectors for functionality.

Key Responsibilities:

  • Be actively involved in designing experiments, supporting assay development.
  • Assist in the decision-making processes for the studies.
  • Communicate cross-functionally across different groups.
  • Actively participate as a leader in team settings including scientific progress meetings.
  • Present data concisely both internally and at conferences.
  • Maintain current knowledge of industry literature related to our studies.
  • Work with CRO’s to ensure good communication and solid documentation.
  • Partner with Finance to maintain and track budget.
  • Publish scientific data.

Minimum Requirements/Qualifications:

  • Requires a PhD in molecular or cell biology or gene therapy field with a minimum of two years+ of related industry experience.
  • Demonstrated expertise with techniques including qPCR, Western blotting, ELISAs, molecular cloning, lentiviral vectors, and hematopoietic stem cell culture is preferred.
  • Previous experience performing (mouse) experiments required.
  • Excellent communication and presentation skills
  • Demonstrated ability working successfully in team environment.
  • Documentation of all work required

To apply, email your resume to: jobs@avrobio.com
AVROBIO, Inc is an EEO employer

About AVRO
AVROBIO, Inc., a leader in lentiviral-based gene therapies, is a clinical-stage company developing disruptive therapies that have the potential to transform patients’ lives with a single dose. The Company is focused on the development of its gene therapy candidate, AVR‑RD‑01, in Fabry disease, as well as additional gene therapy programs in other lysosomal storage disorders including Gaucher disease, Cystinosis and Pompe disease. AVROBIO’s lentiviral platform has broad potential for other rare and non-rare genetic diseases. AVROBIO is headquartered in Cambridge, MA and has offices in Toronto, ON.

AVROBIO is seeking a talented and highly organized, self-starter who is task-focused to join our Human Resources team. The primary role of the Human Resources Generalist is to support the HR Operations functions including, benefits administration, HRIS (ADP) and new hire processing. You will provide timely and exceptional customer service to all employees. This is an outstanding position for a motivated individual with 5 + years of experience in Human .

Job Responsibilities:

  • Administer benefits through a third-party provider including health, dental, life and disability plans.
  • Liaison to all benefits providers.
  • Coordinate with finance and accounting for employee status changes including new hires, leaves of absence, and employee separations.
  • Responsible for benefit changes and enrollments – including the annual Open Enrollment process.
  • Review HR invoices for accuracy and processing.
  • Coordinate and schedule candidate interviews.
  • Conduct initial orientation and onboarding for newly hired employees.
  • Respond to employee benefit requests.
  • Maintain employee files.
  • Track HR metrics as needed.
  • Complete employment verification requests, unemployment claims and background checks.
  • Participates in development of Employee Handbook.
  • Partners with cross functional teams as needed.

Qualifications:

  • Bachelor’s Degree or equivalent work experience.
  • 5+ years in Human Resources with previous experience with benefits administration required.
  • Biotech industry experience required.
  • Proficiency in Microsoft Word, Excel, PowerPoint & Outlook, and HRIS (ADP preferred), DocuSign.
  • Strong customer-service orientation.
  • Effective in operating in a collaborative, fast paced environment with highly confidential information.
  • Well-developed written and verbal communication skills.
  • Solid business acumen as well as current state and federal labor and employment laws.
  • Ability to build and maintain successful relationships with all levels of the organization, achieve credibility, and the ability to influence outcomes.
  • Demonstrates problem solving, conflict resolution, and decision-making skills. Ability to resolve, manage, and communicate complex issues to all levels.
  • Ability to work independently with limited supervision; understands when to escalate issues.

To apply, email your resume to: jobs@avrobio.com
AVROBIO, Inc is an EEO employer

About AVRO
AVROBIO, Inc., a leader in lentiviral-based gene therapies, is a clinical-stage company developing disruptive therapies that have the potential to transform patients’ lives with a single dose. The Company is focused on the development of its gene therapy candidate, AVR‑RD‑01, in Fabry disease, as well as additional gene therapy programs in other lysosomal storage disorders including Gaucher disease, Cystinosis and Pompe disease. AVROBIO’s lentiviral platform has broad potential for other rare and non-rare genetic diseases. AVROBIO is headquartered in Cambridge, MA and has offices in Toronto, ON.

The Executive Assistant is responsible for performing a wide array of administrative functions, as well as special projects, requiring a high degree of integrity, initiative, and resourcefulness. This position requires an individual with strong organizational and analytical skills, able to balance multiple, competing priorities, and anticipate upcoming needs in a fast-paced environment.  Given that daily activities often involve access to sensitive, non-public information, this position necessitates confidentiality, sound judgment, and the ability to prioritize business requirements as priorities change.  In this role, the assistant will interface with internal and external parties on behalf of the executives, including but not limited to investors, board of directors, outside counsel, and KOLs.

Key Responsibilities:

  • Manage complex calendars, scheduling requests, and appointments for the CFO, GC and respective teams. Coordinate various Board Committee meeting dates.  Learn and understand related business requirements to support changing priorities.
  • Handle logistics for internal and external calls, meetings, interviews, department programs, events, and conferences, including invitations, rooms, catering, and materials. Work collaboratively with IR consultant specifically related to logistics and materials for investor conferences and roadshows.
  • Reviews incoming correspondence, initiates replies as appropriate, brings attention to matters requiring action by the executive or their teams and follows up to ensure completion. Provide a weekly summary of outstanding items for review/response.
  • Arrange domestic and international travel, including air, hotel, and ground transportation, as well as visa processing, and international invitation letters.
  • Develop new and modify existing PowerPoint presentations and spreadsheets using appropriate template/branding materials, maintaining electronic and physical files in an orderly and retrievable fashion.
  • Prepare and reconcile expense reports, manage vendors, review invoices, and follow contract and purchase order procedures to facilitate payment.
  • Assist with preparation of quarterly budget reviews.
  • Update department databases, including relevant contact information. Maintain investor database on SharePoint and provide reports as requested.
  • Ad hoc projects as directed.

Minimum Requirements/Qualifications:

  • Minimum 5 years’ experience in a C-level executive administrative support capacity.
  • Associates Degree or equivalent combination of education and experience.
  • Knowledge of administrative procedures and best practices, proficient with MS Office Suite including Outlook, Word, Excel and PowerPoint.

To apply, email your resume to: jobs@avrobio.com
AVROBIO, Inc is an EEO employer

About AVRO
AVROBIO, Inc., a leader in lentiviral-based gene therapies, is a clinical-stage company developing disruptive therapies that have the potential to transform patients’ lives with a single dose. The Company is focused on the development of its gene therapy candidate, AVR‑RD‑01, in Fabry disease, as well as additional gene therapy programs in other lysosomal storage disorders including Gaucher disease, Cystinosis and Pompe disease. AVROBIO’s lentiviral platform has broad potential for other rare and non-rare genetic diseases. AVROBIO is headquartered in Cambridge, MA and has offices in Toronto, ON.

Reporting to the Head of Clinical Operations the Associate Director/Director of Medical Writing will be a key member of the clinical operations team, working closely with the cross-functional AVROBIO team. The position provides an excellent opportunity to gain experience and learn broad aspects of gene therapy regulations. You will manage all aspects of clinical and regulatory document preparation and finalization at the program and study level as well as contribute in meaningful ways to data analysis and interpretation. As a key member of the team, you will have the opportunity to provide strategic direction cross-functionally to ensure key messages are consistently aligned with reporting requirements and company objectives.

Key Responsibilities:

  • Review and edit documents prepared by other writers (internal functional area representatives, CRO, or contractors) as required and ensure quality and adherence to standards
  • Independently prepare complex regulatory and clinical documents including protocols, Investigator's Brochures (IBs), development safety update reports (DSURs), clinical study reports (CSRs), regulatory briefing documents, and clinical sections of regulatory submissions (IMPDs, INDs, CTAs, MAAs and BLAs)
  • Oversight of CRO or consultant medical writers
  • Own the document development lifecycle by maintaining and driving document review cycles and timelines
  • Contribute to overall project management and cross functional working groups as needed to facilitate efficient development and finalization of documents for submissions
  • Ensure document adherence to standard operating procedures (SOPs), good clinical practice (GCP), and the International Council on Harmonisation (ICH)
  • Perform quality control of medical writing documents
  • Assist in the development of templates, style guidelines, and SOPs
  • Generate or assist in evaluating proposals, contracts, and change orders from CROs and other vendors.

Minimum Requirements/Qualifications:

  • Demonstrated ability to communicate and write clearly, concisely, and effectively
  • Ability to complete tasks to deadlines and resolve/escalate problems in a timely manner under limited direction and on own initiative
  • Experience with cross-functional study teams
  • Proficient in Microsoft Word, Excel, Please Review, Sharepoint or other joint writing/editing tools
  • Strong analytical skills and ability to interpret and present complex data clearly
  • Independently motivated, and good problem-solving ability
  • Aptitude for compilation, analysis, and presentation of data
  • Ability to work successfully within a cross-functional team and a matrix organization.
  • Knowledge of current regulatory requirements and guidelines governing clinical research.
  • Ability to manage and communicate effectively with vendors including reviewing requests for proposals, analyzing scope of work, and responding to inquiries and complaints.
  • Must be able to work in a fast paced environment with demonstrated ability to manage multiple competing tasks and demands.
  • Performs other work-related duties as assigned
  • 10+ years clinical/regulatory writing experience with Master’s degree OR 8+ years clinical/regulatory writing experience with PhD in life science or equivalent.

To apply, email your resume to: jobs@avrobio.com
AVROBIO, Inc is an EEO employer

About AVRO
AVROBIO, Inc., a leader in lentiviral-based gene therapies, is a clinical-stage company developing disruptive therapies that have the potential to transform patients’ lives with a single dose. The Company is focused on the development of its gene therapy candidate, AVR‑RD‑01, in Fabry disease, as well as additional gene therapy programs in other lysosomal storage disorders including Gaucher disease, Cystinosis and Pompe disease. AVROBIO’s lentiviral platform has broad potential for other rare and non-rare genetic diseases. AVROBIO is headquartered in Cambridge, MA and has offices in Toronto, ON.

Director, Regulatory - CMC, Gene Therapy

Ensure global strategies are successfully implemented and executed across our portfolios. Interface cross-functionally with internal teams and external service providers/partners. Demonstrate leadership and comprehensive understanding of global RA CMC regulations and guidelines to address and overcome challenges that arise during development and commercialization. Successfully communicate and negotiate directly and indirectly with international Health Authorities as necessary.

Key Responsibilities:

  • Develop and implement global CMC regulatory strategies for clinical and early development stage gene therapy projects.
  • Lead CMC regulatory activities and timelines. Manage and implement planning, preparation and submission of high-quality CMC related applications.
  • Lead negotiations with regulatory agencies to resolve CMC issues and shepherd proactive interactions with regulators globally; lead the preparation and submission of responses to CMC questions; supports interactions with regulatory agencies during GMP and pre-approval inspections.
  • Manage and ensure compliance with all reporting requirements.
  • Provide CMC regulatory guidance for global development programs.
  • Provide regulatory CMC support for clinic development activities. Provide advice and carefully considered decisions regarding regulatory issues for which there may not be clear/specific regulatory guidance or precedence.

Minimum Requirements/Qualifications:

  • BS/BA Degree in a Scientific Discipline, Advanced Degree (PhD) preferred.
  • 8 + years pharmaceutical Regulatory CMC experience including experience as an RA CMC product lead, or equivalent industry experience.
  • Demonstrated hands-on experience in clinical and/or commercial stage gene therapy products.
  • Proven ability to liaise with Regulatory Agencies having served as lead in successful Agency Interactions related to CMC submissions and product development meetings; international experience preferred.
  • Understanding of scientific principles and regulatory CMC requirements relevant to global gene therapy development and post-approval support.
  • Demonstrated experience in preparing IND and/or NDA submissions.
  • Proven ability to deal with issues of critical importance.
  • Demonstrated leadership, problem-solving ability, flexibility and teamwork.
  • Demonstrated ability to work well within a matrix structure in a scientifically complex environment.
  • Exercises good judgment in elevating and communicating actual or potential issues to line management and presents solutions to those issues.
  • Excellent written and oral communication skills are required.

Other Requirements:

  • Travel requirements – 5-10%

To apply, email your resume to: jobs@avrobio.com
AVROBIO, Inc is an EEO employer

About AVRO
AVROBIO, Inc., a leader in lentiviral-based gene therapies, is a clinical-stage company developing disruptive therapies that have the potential to transform patients’ lives with a single dose. The Company is focused on the development of its gene therapy candidate, AVR‑RD‑01, in Fabry disease, as well as additional gene therapy programs in other lysosomal storage disorders including Gaucher disease, Cystinosis and Pompe disease. AVROBIO’s lentiviral platform has broad potential for other rare and non-rare genetic diseases. AVROBIO is headquartered in Cambridge, MA and has offices in Toronto, ON.

Reporting to the Head of Regulatory, you will provide Regulatory support across all programs.

Ensure Regulatory compliance by managing and maintaining Regulatory submissions across AVROBIO’s portfolios. Interface cross-functionally both within AVROBIO and with external service providers/partners. Pro-actively be aware of evolving regulatory requirements, trends and developments for global studies. Manage and update regulatory archiving databases.

Key Responsibilities:  

  • Coordinate and manage the preparation of regulatory submissions and be responsible for maintenance of IND and CTX related activities.
  • Work with and manage CRO Regulatory activities ensuring compliance.
  • Provide support in preparation of the response to Health Authority information requests, agency meetings, and serve as a backup liaison between sponsor and the Regulatory
  • Manage and maintain regulatory filings and communications archiving databases.
  • Contribute to continuous improvement of department processes and SOP creation.
  • Implement and assist in the development of regulatory strategies for programs in development.
  • Participate in cross-functional program/study team activities to provide regulatory guidance as needed.
  • Maintain awareness of evolving regulatory requirements, trends and developments globally.

Minimum Requirements/Qualifications:

  • Bachelor’s degree required with a minimum of 5+ years pharmaceutical industry experience in Regulatory Affairs.
  • Excellent operational skills including planning, organizing and the ability to motivate and gain cooperation from others
  • Ability to work independently with minimal direction and to work well within cross-functional teams
  • Solid listening, oral and written communication skills.
  • Knowledge and experience in interpretation of regulations and guidelines related to drug development
  • Experience in multinational global clinical trials
  • ECTD publishing experience preferred
  • No more than 10%

To apply, email your resume to: jobs@avrobio.com
AVROBIO, Inc is an EEO employer

About AVRO
AVROBIO, Inc., a leader in lentiviral-based gene therapies, is a clinical-stage company developing disruptive therapies that have the potential to transform patients’ lives with a single dose. The Company is focused on the development of its gene therapy candidate, AVR‑RD‑01, in Fabry disease, as well as additional gene therapy programs in other lysosomal storage disorders including Gaucher disease, Cystinosis and Pompe disease. AVROBIO’s lentiviral platform has broad potential for other rare and non-rare genetic diseases. AVROBIO is headquartered in Cambridge, MA and has offices in Toronto, ON.

As a Research Associate, you will perform experimental laboratory work in the field of gene therapy, gene editing screening, hematopoietic stem cell biology, and genetics. Work under the general supervision of a Scientist/Senior Scientist. The technician will be involved in research in the field of ex vivo lentiviral vector gene transfer into hematopoietic stem/progenitor cells with a mission of curing lysosomal storage disorders and rare diseases in one dose. You will assist in all aspects of research to test gene therapy vectors for functionality.

Key Responsibilities:

  • Perform laboratory assays including biochemical assays, cellular staining and flow cytometry analysis, Luminex assays, ELISAs, protein/nucleic acids isolation/quantification, gene expression assays (Taqman PCR), and cell culture.
  • Troubleshoot, optimize assays, and support transfer to CROs.
  • Identify unusual findings and report such findings to supervisor
  • Work according to laboratory standards.
  • Provide required documentation to record methodologies and test results for your work.
  • Maintain equipment and supplies in a neat and orderly manner
  • Use your organizational skills to balance project demands.

Minimum Requirements/Qualifications:

  • BS/MS degree with minimum 4+ year laboratory experience required
  • Familiarity with molecular and cellular biology techniques are required.
  • Experience with transfections, viral transductions, CRISPR/Cas9 and hematopoietic stem cells is strongly preferred.
  • Hands-on experience in the selection, culture, and analysis of human hematopoietic stem/progenitor and immune cells by multicolor flow cytometry is highly desirable.
  • Excellent communication skills are required to work collaboratively with other team members in order to achieve goals and company timelines.
  • Must demonstrate careful attention to detail.
  • Must be able to maintain a neat and orderly working environment.
  • Proven ability to learn new technologies.

To apply, email your resume to: jobs@avrobio.com
AVROBIO, Inc is an EEO employer

About AVRO
AVROBIO, Inc., a leader in lentiviral-based gene therapies, is a clinical-stage company developing disruptive therapies that have the potential to transform patients’ lives with a single dose. The Company is focused on the development of its gene therapy candidate, AVR‑RD‑01, in Fabry disease, as well as additional gene therapy programs in other lysosomal storage disorders including Gaucher disease, Cystinosis and Pompe disease. AVROBIO’s lentiviral platform has broad potential for other rare and non-rare genetic diseases. AVROBIO is headquartered in Cambridge, MA and has offices in Toronto, ON.