Senior Specialist/Manager @ Vor Bio

We 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:

Vor Bio is seeking a Senior Specialist/Manager, CMC Quality Assurance who will be responsible for providing Quality support for CMC Operations at Vor’s internal manufacturing facility and external manufacturing partners. The successful candidate will engage with and support the Quality Control (QC) laboratory, review production data including batch records, QC reports, manage deviations and other quality system records, and perform batch release and disposition. These responsibilities include assisting in and driving risk management activities, and reviewing and approving CMC SOPs, as necessary.

Key areas of responsibility:

Responsible for reviewing and approving clinical manufacturing batch records, testing records, deviations, and other batch related records and performing disposition activities
Responsible for quality assurance oversight of testing and environmental monitoring activities
Responsible for reviewing and approving stability related activities
Review and approve shipping related activities as well as temperature excursions activities
Provide on-the-floor QA support for manufacturing activities as needed
Ensure documentation aligns with regulatory standards and Vor expectations
Review and approve SOPs and specifications as needed
Draft, review, approve quality assurance SOPs as needed

Qualifications:

BA/BS and a minimum of 6-10 years’ experience in a Quality Assurance position within a GMP environment.
Strong knowledge of GMP regulations and quality systems
Ability to support a risk-based approach to Quality Management Systems
Must be able to work collaboratively with cross-functional groups to ensure compliance and adherence to regulations and established procedures.
Should be highly motivated, flexible, and have excellent organizational and communication skills.
Experience with cell and gene therapy products is preferred
Experience with QC analytical methods is preferred
Must be able to work both independently and as part of a multi-disciplinary team
Must be able to work onsite at our Cambridge facility on a regular basis
Experienced, self-motivated individual who can handle multiple priorities to meet project team goals and timelines
Experience in managing relationships with internal departments and external vendors in a collaborative, constructive manner

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.

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