The ideal candidate will have the knowledge/ability to create and implement a Quality Plan and experience to write, implement, and enforce appropriate standard operating procedures (SOPs) to govern development of our drug delivery pipeline. This position will be responsible for all quality assurance activities, including qualification of critical vendors, review and approval of batch records, and release of clinical product. The candidate is expected to be able to develop and implement technical and scientific initiatives, including employee training, process validations, and product investigations. This role will be based at XTuit’s facility, located at the AstraZeneca Biohub in Waltham, MA.
- Establish a GxP quality plan
- Develop Standard Operating Procedures (SOPs), policies, forms, logs, systems, and related documents to ensure GxP compliance
- Oversee and provide GxP training to all staff members
- Ensure quality products and processes by establishing and enforcing quality standards
- Review, revise, and/or approve procedures, test methods, qualification/validation reports, batch production records, product dispositions, and document deviations/non-conformances, out-of-specification results, and corrective and preventive actions
- Audit and qualify raw material suppliers, GLP contract research and GMP manufacturing organizations (CROs/CMOs), and GCP clinical sites
- Maintain all quality documents, files, and systems, including quality agreements, supplier files, analytical trending tables, stability trending tables, and training records
- Write, review, and approve documents to support regulatory submissions
- Participate in an interactive, team-oriented culture with a diverse group of scientists and engineers
- BS or higher degree and >10 years’ experience in the pharmaceutical/biotech industry, with a minimum of 5 years in quality system management
- Extensive understanding of parenteral formulations and product requirements
- Experience with regulatory authority audits and compliance
- Ability to work with and manage people while maintaining a collaborative mindset
- Strong analytical, reporting, and presentation skills
- Exceptional writing abilities
- Keen technical aptitude and ability to understand complex systems, processes, and methods
- Outstanding problem solving, negotiation, and conflict-resolution skills
- Ability to mentor and train staff and to promote process improvements
- Desire to work in a fast-paced, high-energy, start-up environment
XTuit Pharmaceuticals, Inc. is a biopharmaceutical company developing novel microenvironment-activated therapeutics targeting key disease mechanisms that are responsible for hypoxia, decreased drug uptake, drug resistance, and decreased immune response. The Company’s proprietary drug development pipeline and integrated, sophisticated clinical biomarker platform will be used for accelerated clinical development across selected cancers and fibrotic disorders. XTuit’s compounds act through pleiotropic mechanisms to inhibit extracellular matrix synthesis and stabilization, and to silence activated stromal cells, including cancer-associated fibroblasts and stellate cells. As a result, XTuit compounds alleviate hypoxia and enable enhanced drug uptake through solid stress reduction. Moreover, the drugs have been shown to down-regulate stroma-induced tumor and inflammation signaling pathways to overcome treatment resistance. The Company’s founders include Rakesh K. Jain, Ph.D., Andrew Werk Cook Professor of Tumor Biology (Radiation Oncology) at Harvard Medical School and Director, Edwin L. Steele Laboratory for Tumor Biology at the Massachusetts General Hospital; Robert Langer, Sc.D., David H. Koch Institute Professor at the Massachusetts Institute of Technology; Ronald Evans, Ph.D., March of Dimes Chair in Molecular and Developmental Biology and Professor and Director of the Gene Expression Laboratory at the Salk Institute as well as Howard Hughes Medical Institute Investigator; and Alan Crane of Polaris Partners. XTuit is backed by leading investors, including Polaris Partners, New Enterprise Associates, CTI Life Sciences, Arcus Ventures, and Omega Funds.
We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state, or local protected class.