Total 2 job vacancies by Prestige Biopharma Limited

Job Responsibilities

·       Project support: Oversee and drive project management activities by translating process development (PD) milestones (e.g., scale-up, process characterization, validation) into actionable CMC timelines. Manage comprehensive planning, timeline monitoring, and budget tracking for regulatory submissions.

·       Project monitoring: Track and report project status to internal and external stakeholders. Leverage your hands-on process development expertise to technically evaluate CMO/CDMO manufacturing activities, proactively identifying scale-up risks, yield variations, and equipment bottlenecks.

·       Documentation management: Manage, maintain, and critically review technical project documentation, specifically focusing on tech transfer protocols, process characterization reports, master batch records, SOPs, and meeting minutes. Facilitate the rapid collection of technical data from internal process engineers and external vendors.

·       Stakeholder management: Act as the primary technical bridge between internal team and external partners. Coordinate collaborations, manage agreements, and oversee the scientific quality of deliverables from CMOs, CDMOs, and other vendors.

·       Sample and logistics coordination: Handle highly sensitive project logistics, including the coordination of tech transfer materials, analytical sample shipments, and clinical drug sourcing.

·       Regulatory support: Assist in drafting the Quality Section of dossiers for clinical trial and marketing authorization applications. Accurately translate complex PD and analytical data into regulatory documents, ensuring strict alignment with agency expectations.

·       CMC support: Offer strategic and scientific guidance to technical teams on CMC regulatory requirements. Utilize your prior process or analytical development expertise to negotiate, troubleshoot, and resolve complex CMC-related bottlenecks.

Job Requirements

·       A Bachelor's, Master, or PhD degree in a relevant scientific discipline (e.g., Chemistry, Biochemistry, Pharmaceutical Sciences).

·       Proven track record in biologics Process Development, including upstream/downstream process design, optimization, scale-up, and technology transfer.

·       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.

Job Description:

·      Ensure clinical trial processes and procedures are conducted in accordance with GCP, relevant regulations, guidelines, protocol, and quality management system

·      Conduct quality risk assessment and ensure appropriate mitigation of risks

·      Manage document control of quality management system

·      Review and update SOPs and associated documents

·      Prepare and conduct internal process audits, study specific audits, site audits, vendor audits and relevant audit reports

·      Perform Incident/CAPA lifecycle management including root cause analysis, impact analysis and provide suitable recommendations for improvements

·      Perform computerized system validation where required

·      Assist in the conduct of quality management review meetings

·      Keep up to date with regulatory guidelines and legislations and utilize relevant documents to interpret for guidance

·      Conduct vendor qualification

·      Review of relevant clinical trial documents

·      Management of QMS-related and study-specific training

·      Other duties as assigned by line manager/HOD

Requirements/Skills:

·      Bachelor’s degree or equivalent in basic sciences

·      Experience in pharmaceutical industry with knowledge of EU, US and other relevant international regulatory standards and GxP guidelines for the conduct of clinical trials

·      Experience in clinical/regulatory auditing desirable

·      Effective oral and written communication skill

·      Strong analytical and problem-solving skill

·      Good computer skills, inclined to adapt to technology efficiently

·      Results-oriented, multi-tasking, quick learner