What You'll Do:
- Manage end-to-end Quality Control project timelines, supporting activities such as method validation, PPQ (Process Validation) readiness.
- Coordinate cross-functional QC and QA activities to ensure key milestones are met and projects remain on schedule.
- Partner closely with QC laboratory teams, QA, and manufacturing stakeholders to align project deliverables with validation and regulatory timelines.
- Identify risks, dependencies, and potential delays and escalating as needed.
- Facilitate team and cross-functional meetings, including agenda preparation, documentation of meeting minutes, and tracking of action items.
- Ensure effective communication and information flow between QC, QA, manufacturing, and other internal stakeholders.
- Support preparation of project documentation and internal reporting materials such as project timelines, Gantt charts, and status presentations for leadership updates.
- Coordinate with internal teams and external partners/vendors to ensure alignment on testing timelines and deliverables.
- Assist with activities to prepare QC operations and laboratories for GMP readiness and PPQ testing support.
About You
- Bachelor’s degree in a scientific discipline (e.g., Biology, Chemistry, Biochemistry, or related field).
- 5+ years of relevant experience, including: Experience working in or closely supporting a QC laboratory environment and project management or project coordination experience within pharmaceutical, biotech, or life sciences.
- Strong understanding of QC laboratory workflows, including analytical testing, method validation, and support of process validation activities.
- Familiarity with GMP environments and requirements for analytical testing supporting manufacturing.
- Proven ability to manage complex timelines, coordinate multiple stakeholders, and track project deliverables.
- Strong organizational and communication skills with the ability to manage multiple priorities simultaneously.
- Proficiency with Microsoft Office tools (Excel, PowerPoint, Word) and experience using project management tools such as Microsoft Project or similar timeline tracking systems.
- Experience working with cross-functional teams and external vendors.
- Laboratory background and prior hands-on lab experience.
- Ability to travel occasionally for project-related work if required.
Top Skills
What We Do
Adverum Biotechnologies (NASDAQ: ADVM) is a clinical-stage company that aims to establish gene therapy as a new standard of care for highly prevalent ocular diseases with the aspiration of developing functional cures to restore vision and prevent blindness. Leveraging the research capabilities of its proprietary, intravitreal (IVT) platform, Adverum is developing durable, single-administration therapies, designed to be delivered in physicians’ offices, to eliminate the need for frequent ocular injections to treat these diseases. Adverum is evaluating its novel gene therapy candidate, ixoberogene soroparvovec (Ixo-vec, formerly referred to as ADVM-022), as a one-time, IVT injection for patients with neovascular or wet age-related macular degeneration. By overcoming the challenges associated with current treatment paradigms for these debilitating ocular diseases, Adverum aspires to transform the standard of care, preserve vision, and create a profound societal impact around the globe.
.png)
