Our client is a biotechnology company focused on developing innovative therapies for a range of diseases, with an emphasis on precision medicine and immune-based treatments. The company works on harnessing the power of the immune system, using its proprietary platform to develop personalized therapies that target specific disease mechanisms. Our client utilizes advanced technologies such as artificial intelligence (AI), data analytics, and immune system profiling to identify and develop novel drug candidates that can address conditions in oncology and other areas with high unmet medical needs.
Their approach aims to create more effective and tailored treatments, improving patient outcomes while minimizing adverse effects. However, the specific areas of focus may evolve, so it's best to check for the latest updates directly from their website or recent publications.
Lead CMC (Chemistry, Manufacturing, and Controls) activities across the entire lifecycle, from pre-IND to IND/early-stage and late-stage development, covering process development, manufacturing, and supply chain management.
Develop and implement CMC strategies and development plans for multiple oncology-focused preclinical and clinical-stage Antibody-Drug Conjugate (ADC) programs.
Collaborate with CDMOs (Contract Development and Manufacturing Organizations) to establish scalable and reproducible manufacturing processes that align with target product profiles.
Provide CMC program management support, ensuring that timeline and budget goals are met.
Review key documents from CDMOs, including process development reports, master and executed batch records, stability protocols, change controls, and other necessary documentation.
Participate in internal ADC Project Team Meetings and CMC sub-team meetings. Represent the team in external meetings with CDMOs and other partners.
Author and review sections of regulatory filings, including pre-IND, IND/IMPD, annual reports, BLA/MAA, and others. Support interactions with regulatory authorities as required.
Ensure effective coordination across functions, including CMC, clinical, non-clinical, and regulatory teams, to support the execution of integrated program plans.
Proactively identify potential issues and obstacles that may affect the timely advancement of CMC deliverables, and collaborate with internal and external teams to resolve these challenges.
Qualifications:
A Bachelor's degree is required; a Master's or PhD is preferred.
Minimum of 12+ years of experience in CMC operations, CMC project management, or related scientific fields.
Strong experience with Antibody-Drug Conjugates (ADCs) is essential.
In-depth knowledge of CMC operations, quality, and regulatory requirements.
Proven ability to understand company priorities, objectives, and project timelines. Ability to define and manage critical paths, identify and escalate issues, and contribute to their resolution.
Strong troubleshooting skills, with the ability to address complex issues using appropriate information.
Ability to thrive in a fast-paced, cross-functional team environment. Capable of building consensus and resolving issues while maintaining positive working relationships across functions.
Demonstrated experience in coordinating among stakeholders with both technical and business priorities.