Location: South Boston,MA, USA
Description JOB TITLE: Quality Control Data ReviewerDEPARTMENT: Technical Operations DATE PREPARED: October 3, 2024JOB SUMMARY: At Aveo, we are dedicated to advancing cancer care through innovative research and development. Our mission is to deliver transformative therapies that improve patient outcomes and quality of life. We are seeking a detail-oriented Quality Control Data Reviewer to support our commitment to excellence in oncology data management.The Quality Control Data Reviewer in Technical Operation department will play a crucial role in ensuring the accuracy, reliability, and integrity of analytical data within our oncology programs. The ideal candidate will have a strong analytical background, deep knowledge of iStability software and clear understanding of data quality principles, particularly in the context of validation, release and stability data.PRINCIPAL DUTIES: Managing iStability software by submitting and maintaining all stability data available up to date for clinical development candidates and commercial materials in AVEO's product portfolio. Review and approval of stability data entries against raw data and iStability studies for accuracy, completeness, and compliance with regulatory standards, where applicable. Identify discrepancies, trends, and anomalies in data sets, and work with technical operation applicable teams to investigate and resolve issues. Review of stability protocols and reports and keep track of the pull dates. Review of analytical validation protocols, reports, and raw data and support in identifying and resolving any discrepancies and/or deviations Review of vendor raw data available for clinical development candidates and commercial materials in AVEO's product portfolio in a timeline manner. Review of external and or internal analytical documents associated with AVEO's product portfolio. Reviews regulatory documentation supporting drug substance or drug product sections for INDs, NDAs, MAAs, etc. Assure that all aspects of stability operations comply with applicable SOPs. Review and/or revision of internal SOPs related to stability, specifications, and data review as applicable Collaborate with cross-functional teams, including Technical Operations, Quality Assurance, and Regulatory Affairs, to support clinical programs and commercial products. Assist in training staff on iStability when required. Stay informed about industry trends, regulatory updates, and best practices related to stability data management. Ideal candidate will have strong attention to detail, effective communication skills, strong knowledge of analytical methodologies and applying/interpretation of GMP requirements, and the ability to work in a fast-paced environment, manage priorities and maintain timelines for multiple projects.REQUIRED QUALIFICATIONS/EXPERIENCE (BASIC QUALIFICATIONS): Requires a BS/BA. in Chemistry, Biochemistry or equivalent scientific discipline 1-3 years' experience in performing stability studies in a pharmaceutical / biopharmaceutical laboratory under regulated environment. Strong background on iStability software. Familiarity with cGMP, USP/EP, ICH, and FDA/EMEA regulations for biopharmaceutical products. Knowledgeable in the analytical methodologies utilized for small molecules and/or monoclonal antibodies for early clinical through late stage/commercial manufacturing. Written and verbal communication skills. Proficiencies with Microsoft Office and associated applications. Attention to detail and the ability to work independently and as part of a dynamic team environment with minimal supervision.About AVEOAVEO is a commercial-stage, oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for patients with cancer. AVEO currently markets FOTIVDA (tivozanib) in the U.S. for the treatment of adult patients with relapsed or refractory renal cell carcinoma (RCC) following two or more prior systemic therapies. AVEO continues to develop FOTIVDA in immuno-oncology combinations in RCC and other indications and has several other investigational programs in clinical development. AVEO is committed to creating an environment of diversity, equity and inclusion to diversify representation within the Company.All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.