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Quality Control Manager, Biologics
2 months ago
Summary
The Quality Control Manager for Biologics is responsible for managing the quality control processes for biologics products, ensuring their integrity and compliance from development to production. This includes managing CDMO activities related to QC aspects of Visterra clinical trial candidates, developing and implementing QC protocols, managing stability programs, and ensuring compliance with regulatory requirements.
This is a full-time position based in Visterra’s facility in Waltham, MA.
Responsibilities
- Oversee the stability program and QC activities at Visterra.
- Coordinate with other departments to align QC activities with company goals.
- Develop, implement, and maintain quality control systems and protocols for biologics.
- Oversee routine and non-routine testing of raw materials, in-process materials, and finished products.
- Ensure all QC activities are accurately and timely documented.
- Develop, implement, and manage stability programs for biologics products.
- Ensure stability studies are conducted according to regulatory guidelines and company SOPs.
- Analyze stability data, identify trends, and report findings to senior management and relevant stakeholders.
- Ensure all QC processes comply with applicable regulations.
- Prepare for and participate in QA audits, contribute to regulatory updates and responses regarding stability.
- Maintain up-to-date knowledge of regulatory requirements and industry best practices.
- Analyze QC and stability data to identify trends, deviations, and areas for improvement.
- Generate and review QC and stability reports, ensuring accuracy and completeness.
- Communicate findings and recommendations to senior management.
- Stay informed about advancements in QC technologies and methodologies.
- Oversee investigations into quality issues, deviations, and non-conformances at CDMOs.
- Work closely with Quality Assurance and Regulatory groups to ensure QC processes align with overall quality and regulatory strategies.
- Participate in cross-functional meetings to provide QC insights and support decision-making.
- Occasional travel to other company locations, CDMO sites may be required.
Minimal requirements
- Bachelor’s or Master’s degree in Biochemistry, Biotechnology, Chemistry or a related field.
- Minimum of 5-7 years of experience in quality control within the biopharmaceutical industry, specifically with biologics.
- Hands-on experience with various QC techniques and instrumentation used in biologics.
- Experience in managing stability programs and analyzing stability data.
- Strong understanding of regulatory requirements and industry standards.
- Excellent leadership, communication, and interpersonal skills.
- Proficient in data analysis and QC software/tools.
- Ability to manage multiple projects and prioritize effectively.
- Strong problem-solving and critical thinking abilities.
- Ability to work in a laboratory environment and adhere to safety protocols.
Company
Visterra is a clinical stage biotechnology company committed to developing innovative antibody-based therapies for the treatment of patients with kidney diseases and other hard-to-treat diseases. Our proprietary technology platform enables the design and engineering of precision antibody-based product candidates that specifically bind to, and modulate, key disease targets. Applying this technology to disease targets that are not adequately addressed by traditional therapeutic approaches, we are developing a robust pipeline of novel therapies for patients with unmet needs.
Visterra is a wholly owned subsidiary of Otsuka America, Inc., which is a U.S. holding company and a wholly owned subsidiary of Otsuka Pharmaceutical Co., Ltd. of Japan. Visterra has approximately 85 employees and is located in Waltham, Massachusetts.
Visterra provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
