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The Manager/Senior Manager of Quality Control will oversee the method qualification and verification activities for clinical programs, manage personnel performing GMP testing, and ensure regulatory compliance in method validation and verification. Responsibilities also include performing analytical assays and reviewing QC data throughout the product lifecycle.
The Senior Specialist in Quality Control will perform analytical assays, support GMP laboratory operations, review QC data from method qualifications, and assist in documenting experiments. This role requires strong leadership and multitasking abilities within QC lab operations to ensure compliance and readiness for drug substance testing.
The Executive Director/Vice President will lead two Program teams focused on genome editing therapies, guiding them from early development to registration. Responsibilities include providing strategic leadership, ensuring alignment across development teams, managing program budgets, and fostering collaboration and innovation while maintaining clear communication with stakeholders.
The VP of Portfolio, Programs and Alliance Management (PPAM) is responsible for setting the strategy for managing programs and alliances, improving PPAM capabilities, leading governance forums, and driving program development. This role includes monitoring risks, resolving resource challenges, and promoting effective communication within teams to align with enterprise goals.
The Co-op will assist the Antibody Engineering team by performing antibody productions, developing analytical methods for potency assays, and supporting in vitro and in vivo studies. Responsibilities include designing and executing experiments, presenting findings, and ensuring adherence to lab safety protocols.
The Senior Engineer I/II in Computational Biology will design and develop databases for storing large volumes of data, develop computational biology pipelines using cloud technologies, and collaborate with various teams to integrate solutions for research in clinical investigations. The role requires strong programming skills and a solid understanding of data management in a fast-paced environment.
The Human Resources Service Delivery Lead will enhance the employee experience by managing HR operations throughout the employee lifecycle, implementing improvements in HR service delivery, developing documentation frameworks, and utilizing HR systems. The role involves analytical problem-solving and collaboration to drive efficiency and innovation.
The Head of Clinical Operations will oversee global clinical trials, manage vendor relationships, and ensure compliance with FDA and GCP guidelines. Responsibilities include strategic planning for clinical studies, patient recruitment, regulatory submissions, and leading the clinical operations team to achieve corporate goals.
The Executive Director, Regulatory Science (CMC) will lead the development of regulatory strategies for biopharmaceutical products, oversee regulatory submissions, manage a regulatory CMC team, and engage with regulatory agencies to resolve issues and refine strategies, ensuring compliance with global regulations.
The Engineer II role focuses on developing and characterizing lipid nanoparticles (LNPs) for in vivo delivery of editing payloads. Responsibilities include executing experimental design, performing LNP characterization, troubleshooting lab workflows, and maintaining documentation. The position requires collaboration with various scientific teams to ensure high-quality results.
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