Pharmaceuticals & Medical Devices (Healthcare & Medical)Oversee project planning, documentation, timelines, and budget management.Coordination of Quality Section in Dossiers:Coordinate internal and external activities related to the Quality section of dossiers.Provide strategic guidance to technical teams regarding CMC regulatory requirements.Review and Compliance Oversight:Review technical documents from various teams for accuracy, compliance, and completeness for regulatory submissions.Due Diligence and Regulatory Agency Meetings:Prepare briefing packages and support cross-functional teams in due diligence and regulatory agency meetings.Engage in negotiations to address and resolve CMC issues.Author and drive completion of the Quality section of dossiers for clinical trial and marketing authorization applications.Ensure final versions align with requirements and meet regulatory agency expectations.Subject Matter Expertise:Monitor activities of CMO/CDMO and provide CMC subject matter expertise.Review or approve technical documents (e.g. tech transfer documents) and address or escalate CMC/Quality issues.Vendor Management and Procurement:· Assist in vendor discussions, procurement processes, and shipment activities.Workflow Optimization:Identify inefficiencies and improve workflows to ensure the efficient operation of the CMC and Bioanalysis department.Collaboration and Goal Achievement:Collaborate with Team Leaders and members of the CMC Lab and Quality Assurance to ensure department goals are efficiently met.Stay informed about relevant industry and agency guidance to maintain regulatory intelligence.RequirementsA bachelor's, Master, or PhD degree in a relevant scientific discipline (e.g., Chemistry, Biochemistry, Pharmaceutical Sciences).Demonstrated experience in overall project management. Certification in project management (e.g., PMP) would be advantageous.In-depth knowledge and understanding of Chemistry, Manufacturing, and Controls (CMC) regulatory requirements and processes, particularly in the authoring or management of Quality sections of dossiers for clinical trial and marketing authorization applications of biologics drug.Strong collaborative skills, with the ability to work effectively with cross-functional teams, vendors, and alliance partners.Meticulous in reviewing technical documents to ensure accuracy, compliance, and completeness.Knowledge of bioprocessing, functional assays and physiochemical characterization of monoclonal antibody is a plus.Your application will include the following questions: Which of the following statements best describes your right to work in Singapore?What's your expected monthly basic salary?How many years' experience do you have as a Project Manager?How much notice are you required to give your current employer?Prestige Biopharma is one of the fastest growing biopharmaceuticals focusing on the development of biosimilars and first-in-class antibody drugs as well as vaccines for infectious diseases.With decades of R&D and operational experience in drug discovery, we expedite future biologics development and commercialization in a concerted approach based on our proprietary technologies and scientific capabilities.Prestige strives to become a global innovator through the development of first-in-class antibody therapeutics including PBP1510 anti-PAUF mAb for pancreatic cancer (INN-Ulenistamab) that recently obtained orphan designation from FDA, EMA and MFDS. Prestige's rich portfolio of biosimilars in various stages including HD201 trastuzumab in EU EMA's MAA review, HD204 bevacizumab in global Phase 3, PBP1502 adalimumab in Phase 1 and others, is aimed to provide affordable quality medicines to those who need. Prestige has expanded its business into development and manufacturing of vaccines through its global scale vaccine center, starting with partnered commercial production of COVID-19 vaccines.Prestige Biopharma is one of the fastest growing biopharmaceuticals focusing on the development of biosimilars and first-in-class antibody drugs as well as vaccines for infectious diseases.With decades of R&D and operational experience in drug discovery, we expedite future biologics development and commercialization in a concerted approach based on our proprietary technologies and scientific capabilities.Prestige strives to become a global innovator through the development of first-in-class antibody therapeutics including PBP1510 anti-PAUF mAb for pancreatic cancer (INN-Ulenistamab) that recently obtained orphan designation from FDA, EMA and MFDS. Prestige's rich portfolio of biosimilars in various stages including HD201 trastuzumab in EU EMA's MAA review, HD204 bevacizumab in global Phase 3, PBP1502 adalimumab in Phase 1 and others, is aimed to provide affordable quality medicines to those who need. Prestige has expanded its business into development and manufacturing of vaccines through its global scale vaccine center, starting with partnered commercial production of COVID-19 vaccines.Don't provide your bank or credit card details when applying for jobs.#J-18808-Ljbffr
