29 applicants
Visterra Inc. · 2 days ago
Quality Control Manager, Biologics
Waltham, MA
Full-time
Onsite
Senior Level
5+ years exp
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Hiring Manager
Eric Gaffen
Insider Connection @Visterra Inc.
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.
Qualification
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Required
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 Inc.
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.
51-200 employees
H1B Sponsorship
Visterra Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (2)
2022 (3)
2021 (3)
2020 (3)
Funding
Current Stage
Growth StageTotal Funding
$125.39MKey Investors
Temasek Holdings
2018-07-11Acquired· by Otsuka Holdings ($430M)
2017-10-05Series C· $23.6M
2016-06-01Series C· $23.1M
Leadership Team
Brian Pereira
President & CEO & Board Member
P
Peter Courossi
Chief Financial Officer
Recent News
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Company data provided by crunchbase
