Jobs at Lambda Therapeutic Research

We are seeking an experienced Senior Manager – CDMO IT to lead IT infrastructure, computerized system validation (CSV), and digital compliance initiatives within its pharmaceutical and biopharmaceutical CDMO operations. The role involves implementing and maintaining enterprise applications, manufacturing execution systems, laboratory information management systems, electronic batch records, and process automation interfaces. The successful candidate will ensure compliance with GxP requirements, GAMP 5, data integrity principles, and applicable pharmaceutical regulations while overseeing system validation, cybersecurity, user access management, backup and recovery, vendor assessments, and audit readiness. 

• Lead the planning, implementation of IT infrastructure and network for the process and analytical functions of CDMO.
• Oversee and support during installation and implementation of IT systems, manufacturing equipment, Enterprise applications like SAP ERP, Document Management Systems, Testing and Training Systems and Quality and Manufacturing systems like SCADA, PLCs, MES (eBMR, L2 Integration), LIMS and other highly complex automated systems.
• Support the technical team to ensure that process data is available via OPC/similar interfaces to centralised data base systems (e.g. Aveva PI).
• Develop, implement and ensure consistent and documented compliance to required CSV frameworks, policies, and procedures in alignment with pharmaceutical industry regulations (GxP, GAMP5, Safety Health & Environmental (SHE), Data Integrity (DI), Quality and Best Practice requirements etc.).
• Act as a system administrator for IT system and be primary SPOC for user management access functions.
• Act as a custodian of electronic data and be responsible for data backup and restoration.
• Assist vendor for troubleshooting related to IT systems.
• Understand the QMS requirements and collaborate with cross-functional teams to ensure quality standards for software development, infrastructure management, and data integrity.
• Provide regular, accurate and timely reporting of progress to the Site leadership, CQA, IT-QA, Project sponsors and Stakeholders.
• Ensure that computer systems, processes, and documentation adhere to regulatory requirements and internal quality standards, and be primary presenter during audits. Collaborate with Supplier, QA & ITQA teams to address audit findings and implement corrective and preventive actions (CAPAs).
• Assess, evaluate, monitor and carry out periodic reviews of computer systems for validation, user access management, data integrity, and compliance with relevant regulations.
• Maintain and update IT compliance documentation, including SOPs and validation documents, and follow periodic Training and Evaluation plan for the team to ensure that site is ready for audit.
• Carry out gap assessment/periodic review of GxP computerized equipment to meet regulatory requirements.
• Carry out the assessment of various IT system vendors including providers for cloud services.
• Check compliance of GxP application servers' security and data back-up and restoration procedure. Initiate/review QMS elements related to computerized systems.
• Create sponsor specific firewalls for all aspects of data integrity and security.

Key Deliverables

• Responsible for preparation and review of documentation related to qualification of LIMS, ELN and any other digital platforms.
• Responsible for CSV, ELN, LIMS, EBMR and related software troubleshooting.
• Be subject matter expert for all the digital platforms.
• Ensure the quality and suitability of IT systems installed in the CDMO facility for maintaining integrity and safety.

Allied Responsibilities

• Manage multiple projects and reporting.
• Good understanding of manufacturing instruments and validation.

• Bachelor's/Master's in Computer Applications/Information Technology.
• 8 to 12 years of relevant work experience in CSV and digitization in the pharmaceutical industry.
• Preference for prior experience in Information Technology, CSV digital platforms and their compliance.
• Work experience on digital compliance in the Pharmaceutical/Bio-pharmaceutical industry strongly preferred.
• A strong understanding of equipment used in biopharmaceutical manufacturing and testing as it relates to IT aspects.
• Strong cross functional communication skills highly desirable.
• Excellent oral and written communication and interpersonal skills.