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SalaryWe engineer stem cell transplants that shield healthy cells from targeted therapies
Targeted therapies work by attacking cells that express particular proteins on their surface. Unfortunately, both diseased and healthy cells often express the same proteins, resulting in collateral damage to healthy cells.
At Vor Bio, we engineer hematopoietic stem cells (HSCs) to lack a biologically redundant target protein, then transplant these cells into the patient.
These eHSCs give rise to generations of new healthy blood cells that are effectively shielded from targeted therapies so that only the remaining cancer cells are killed. We are also developing our own CAR-T cell therapy using T cells from the same healthy donor who could potentially provide HSCs for our shielded stem cell transplant and thereby, avoid issues of donor-mismatch. We believe our CAR-T cell therapy may enable more potent and durable responses post-transplant.
Vor Bio is aiming to cure blood cancers through our novel platform combining HSC biology, genome engineering, and targeted therapies to unlock treatment options previously unavailable to patients. Come be a part of a passionate team striving to collaboratively develop a groundbreaking approach to cancer treatment, one of medicine's greatest challenges.
What we value in our fellow Voracians
Passion: Enthusiastically driving our science toward innovative medicines
Fellowship: Fostering genuine bonds of collaboration and mentorship
Humility: Acting selflessly by putting the collective mission first
Who we are looking for:
A member of Vor Bio's Manufacturing team, the Compliance Specialist will lead investigations, CAPAs and Change Controls related to our internal manufacturing. In addition, this role will help build out the sterility assurance program including aseptic operator qualification and ongoing aseptic process qualifications and support equipment lifecycle management.
Key areas of responsibility:
- Provide quick, quality-based decisions while serving as the immediate escalation path for all operational staff during cell therapy manufacturing activities
- Facilitate and lead critical site meetings to investigate and coordinate the resolution of manufacturing deviations and investigations, CAPAs, change controls through use of Root Cause Analysis tools and risk assessments.
- Support manufacturing continuous improvement initiatives
- Establish key performance indicators in alignment with department goals, maintain and report applicable area or organizational metrics
- Collaborate with appropriate stakeholders to author, review or revise applicable SOPs, batch records, and other operational related documents
- Conduct technical training for manufacturing operations
- Conduct review of aseptic operations to ensure compliance to procedures (e.g., gowning, cleaning, sanitation, sterility, environmental monitoring, etc.) and USP/FDA regulations
- Other tasks and duties as assigned by Area Management
Qualifications:
- Highly skilled, flexible worker with strong people skills and an extensive background in cGMP manufacturing
- Bachelor's degree in a related field with a minimum of 5 years of experience working in the pharmaceutical or biotechnology industry
- Knowledge and experience in Current Good Manufacturing Practices (cGMP) regulations, documentation, and compliance
- Experience leading investigations, technical writing, and sterility assurance
- Minimum of 3 years of cGMP production experience or Quality Assurance
- Direct experience in Cell Therapy manufacturing and associated specialized equipment)
- Excellent communication and organizational skills with an ability to prioritize effectively and work cross-functionally to deliver results within established timelines
- Must be detail oriented, able to work in a fast-paced environment
By becoming a team member here at Vor, you'll have access to competitive health, dental, and vision coverage, as well as life insurance, and short term and long-term disability insurance. We value work life balance, you'll benefit from discretionary time off, parental leave, and an excellent 401(k) package. We also offer a generous transportation stipend to commute as you wish. We are conveniently located in Cambridge with easy access to public transportation and ample parking.
As an equal opportunity employer, we at Vor Bio know that diversity inspires innovation, inclusiveness, and creativity. We invite you to come as you are. All applicants will be considered for employment agnostic to race, age, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.
Please visit our website at https://www.vorbio.com/ for more information.
