Munazza Qayyum

Hardworking, detail-oriented and passionate Project Manager with strong organizational and skills eager to secure entry-level Senior Project Manager position. Ready to help team achieve company goals. Currently, I am working as a Project Manager with +5 years of expertise in leading cross-functional teams and organizing business operations and resource management to achieve smooth flow and project operations. Monitors projects by adhering to production schedule and budget, managing production team, identifying problems and providing targeted solutions. Ability to handle multiple projects simultaneously with a high degree of accuracy.

As a project manager my core values lie in bringing my team members together in a positive environment so they can achieve positive reults. Proven record in maintaining excellent communication and relationship skills with all stakeholders throughout the project life cycle. Ability to work well under pressure, which is one of the motivation factors to me to work harder. In addition to this, I adapt easily to changes e.g., when a project leads into a different direction. I have great passion for improving myself on a professional and personal level, which will challenge my problem-solving skills and allow me to continue to develop my knowledge and competences as a project manager and informal leader.

• Purification of primary cells from PBMCs
• RNA isolation
• Northern and western blotting
• SDS-PAGE
• QPCR
• Co-IP
• RT-PCR
• Molecular cloning
• Cell culture (primary and cell lines) and transfection (HEK293 and Jurkat cells)
• Alamar blue assay
• In vitro transcription
• ELISA
• Flow cytometry
• EMSA

• 07/2022, Project Manager, Manufacturing Science & Technology, Xellia Pharmaceuticals ApS, Project manager for all types of projects related to API sterile manufacturing incl. Tech Transfer projects (global)., Manage and participate in relevant projects from initiation phase to hyper care in cooperation with R&D, engineering, production, technical service etc., Responsible for ensuring that the outcome of the project complies with requirements from the authorities, GMP regulations and customers (if applicable)., Secure acceptance and approval of deliverables from the project sponsor and steering committee. Implement decisions made by the steering committee., Lead cross functional teams (resource planning, coaching, review quality work, create high performing teams)., Responsible for communication, including status reporting, risk management, escalation of issues that cannot be resolved in the team., Keep overview of trends within the technical and scientific fields of interest to the project and encourage project members to use green and modern techniques., Support assessment of new projects., Support operations and maintain compliance within the API Production in CPH., Support daily production and project teams with technical support and process knowledge in cooperation with specialist and managers., Support operations with deviations, OOX, CAPA and Change Control in connection to daily operations and projects., Assist during audits and inspections with technical expertise including handling of observations., Editing and preparing both existing and new SOP's and instructions., Training and guiding operators according to Xellia SOP's including ensuring LMS is updated and used for registration of training., Maintaining and archiving technical specification and GMP documentation (i.e. Equipment specification documents and validation documents), Support engineering in connection to test and IQ/OQ qualification activities., Manage and execute PQ Qualification and validation activities.
• 09/2018, API Project Manager and Final Handling Specialist, Xellia Pharmaceuticals ApS, Qualification, Validation, Process optimization, Handling of changes and documentation, Hypercare, Support to production, Documentation handover to relevant stakeholders, Coordinating and participating in audit/inspection related to projects., New organization: project execution and definition of roles/responsibilities in the team., RA related projects, Handling of complex deviations and OOS/OOE/OOT cases, Production support (incl. training of specialists in e.g. deviations, batch documentation comments., Other projects (Task Force), Handling Continuous Process Verification reports, APQR
• 08/2015, 08/2018, Production Academic, Freeze Drying Department, Xellia Pharmaceuticals ApS, Batch documentation review., Handling of deviations incl. OOS/OOT/OOE, CAPA´s and changes., Optimization of batch review and batch release flow (collaboration with QA)., Production support., Training of operators/assistants/specialists in batch review and/or documentation/process related optimizations.
• 05/2015, 07/2015, Manufacturing Quality Assurance (MQA) Specialist, FDF, Xellia Pharmaceuticals ApS, Working with stability studies, FDF., Keep updated with the Pharmacopoeias incl. supplements, Pharmeuropa and Pharmacopeial Forum., Coordinating and following up on different projects involving the Quality Unit, including global and domestic projects., Supporting the Quality Unit locally and globally regarding ad hoc issues, incl. but not limited to preparation of specifications, changes, deviations and trouble shooting in relation to OOS/OOT issues., Support any project upon request within the company as a whole wherever feasible, including coordination of laboratory studies., Assisting in answering any enquiry to the Quality Unit from authorities, external and internal customers., Keep updated within the technical and scientific fields of interest to the department and the Quality Unit., Maintaining and developing SOPs related to the department., Evaluation, trending and maintenance of stability data (FDF)., Validating and approving stability protocol templates and stability product specifications in Laboratory Information Management System (LIMS)., Coordinating and assisting in the observations from audits and inspections within MQA.
• 04/2013, 04/2015, Product Specialist / Office Manager, Biotech-IgG A/S, Order processing, marketing and sales of Molecular Diagnostic and Life Science products., Responsible for purchasing and logistics., Ensuring that all products dispatched conform to the company´s procedures., Working with ISO Standards (13485, 9001, 14001) and assisting in audits., Supporting the investigation of customer complaints and non-conformities incl. technical support., Controlling and managing the office., Coordinating and attending customer meetings, exhibitions, and conferences., Translating (English to Danish) product manuals.
• 2003 - 2006, Medical Interpreter (Urdu-Danish), SK Tolkeservice ApS

• Date of Birth: 11/26/82
• Gender: Female
• Nationality: Danish

• CD46 costimulation leads to enhanced T cell activation and microrna expression, Immunobiology, 217, 11, 1148-1149, November 2012
• The Noncoding RNA nc886 Regulates PKR Signaling and Cytokine Production in Human Cells, The Journal of Immunology, 202, 1, ji1701234, December 2018

Project Leadership, Module 3 - Execution, results and completion at Mannaz