Senior Manager - GCP, GVP, GLP Quality

January 4

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Cullinan Oncology

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Cullinan Oncology is a biopharmaceutical company focused on developing targeted therapeutics to create new standards of care for patients, especially in the fields of oncology, immunology, and translational medicine. With a unique approach to research and development, they identify high-impact targets and pursue the best modality to maintain a deep and diverse pipeline of transformative therapies. Cullinan Oncology emphasizes collaboration both internally and with external academic and industry partners, with the goal of efficiently advancing promising therapies for cancer and autoimmune indications. Their approach is modality-agnostic, aiming to leverage the best scientific collaborations to benefit patients.

Oncology

11 - 50 employees

Founded 2018

🧬 Biotechnology

💊 Pharmaceuticals

💰 $10M Post-IPO Equity on 2022-03

📋 Description

• Cullinan Therapeutics, Inc. (Nasdaq: CGEM) is a biopharmaceutical company dedicated to creating new standards of care for patients. • We have strategically built a diversified portfolio of clinical-stage assets that inhibit key drivers of disease or harness the immune system to eliminate diseased cells in both oncology and autoimmune disease. • Our portfolio encompasses a wide range of modalities, each with the potential to be best and/or first in class. • Anchored in a deep understanding of oncology, immunology, and translational medicine, we create differentiated ideas, identify the most appropriate targets, and select the optimal modality to develop transformative therapeutics across a wide variety of cancer and autoimmune indications. • We push conventional boundaries from candidate selection to differentiated therapeutic, applying rigorous go/no go criteria at each stage of development to fast-track only the most promising molecules to the clinic and, ultimately, commercialization. • With deep scientific expertise, our teams exercise creativity and urgency to deliver on our promise to bring new therapeutic solutions to patients. • The Senior Manager of GCP/GVP/GLP Quality is a responsible member of the R&D GxP QA team and provides QA expertise, consultation and oversight with regard to GxP activities for branded biotechnology and pharmaceutical development products. • The Sr Manager of GCP/GLP/GVP QA will assist in the development and maturation of a Phase appropriate Quality Management System (QMS). This involves engaging and collaborating with cross-functional internal and external teams to evaluate processes, procedures, and activities for adherence to relevant industry standards, regulatory guidelines, and company Standard Operating Procedures (SOPs) as appropriate. • The incumbent will support, conduct and/or interpret internal and external GCP/GLP/GVP audits with a focus on risk mitigation and management as well as process improvement. • The Sr Manager of GCP/GLP/GVP will also be part of cross functional NDA/BLA filing diligence, inspection readiness and inspection support.

🎯 Requirements

• Strong knowledge of GCP and Food & Drug Administration (FDA), European regulations, and ICH guidelines gained through direct experience in the drug development process gained through working for a branded biotech or pharmaceutical company. • Working knowledge of supporting preparation, submission, and pre-approval activities, specifically in relation to GCP, GLP and PV Quality, for global regulatory filings for branded pharmaceutical/biotech products. • Ability to influence others as part of a collaborative team and negotiate effective solutions to complex problems; strong interpersonal and social skills. • Minimum six to eight (6-8) years of related CQA, GCP, PV experience, and/or combination of experience and education/training. • Bachelor's degree in a relevant field, such as Life Sciences or Healthcare required. Advanced degree preferred. • Authorization to work in the US for a company. • Candidates located within commuting distance of the Cullinan Cambridge MA office preferred. Candidates on East Coast or Central US considered. • Ability to travel up to 25%.