Ripal Patel

• Company Overview: Fusion pharmaceuticals is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Fusion connects alpha particle emitting isotopes to various targeting molecules to selectively deliver the alpha emitting payloads to tumors.
• Experienced in cGMP manufacturing environment and working with FDA cGMP 21CFR211 guidelines.
• Trained to dispense and handle radioactive substance like Iodine-131, Iodine-124, Lu-177, In-111 and Ac-225.
• Experienced in Current Good Manufacturing Processes (cGMP), Regulatory Guidelines, Aseptic Manufacturing.
• Experience with HPLC, radiochemistry synthesis, Radiation Safety Principles, Isotopes production using automated synthesis unit and analytical equipment troubleshooting.
• Maintaining weekly scheduling, meetings, planning work; appraising and coaching performance as well as any relevant training
• Leading the teams and actively interviewing, hiring and training new team members in the team
• Support formulation development for analytical testing related to stability, compatibility and pre-validation studies
• Responsible for coordinating and directing all aspects of Isotope production and Led the setup and commissioning of a state-of-the-art facility for the production of [177Lu] n.c.a. in Radiopharmaceuticals, ensuring compliance with regulatory standards and Good Manufacturing Practices (GMP).
• Directed the installation and operational testing of new facility equipment, ensuring seamless integration of processes and maximizing efficiency in the production workflow.
• Oversaw the technical transfer of processes to the new facility, collaborating with R&D teams and production staff to ensure successful scale-up and operational readiness.
• Played a key role in the development and implementation of the Quality Management System (QMS) at the facility, establishing key documentation and ensuring full alignment with industry standards.
• Managed vendor relations, identifying and sourcing critical materials and equipment for the manufacturing process. Negotiated contracts and coordinated timely procurement, ensuring availability of all required resources
  for production.
• Developed and managed cross-functional teams to support continuous improvement initiatives, operational excellence, and the seamless production of [177Lu] n.c.a.,Iodine-131, Iodine-124, In-111 and Ac-225radiopharmaceuticals.
• Contributed to process optimization efforts, streamlining production timelines and improving product yield while maintaining the highest quality and safety standards.
• Ensured timely and accurate reporting of manufacturing progress, metrics, and compliance documentation to senior management and regulatory bodies.

• Company Overview: My department at Atomvie involves the discovery, development and distribution of next generation Radiopharmaceuticals. The products are customized and used daily for the detection and treatment of human diseases such as cancer
• Working experience in clinical trials and development with Radiopharmaceutical research and process development in grade A cleanrooms with given protocols and procedures
• Support formulation development for analytical testing related to stability, compatibility and pre-validation studies
• Ensure, in collaboration with the production staff, consistent production of radiopharmaceuticals according to operational expectations
• Maintaining weekly scheduling, meetings, planning work; appraising and coaching performance as well as any relevant training
• Act as point of contact for other departments and team members for matters related to the GMP Production Facility
• Working in scaling up current processes and improving for new and current formulations with research and development team
• Trained to dispense and handle radioactive substance like Iodine-131, Iodine-124, Lu-177, In-111 and Ac-225
• Experienced in Current Good Manufacturing Processes (cGMP), Regulatory Guidelines, Aseptic Manufacturing, as well as bulk intermediate and medical device manufacturing
• Maintain documentation to fulfill all customer, facility, Provincial, Federal and applicable International regulatory requirements relating to nuclear safety and cGMP manufacturing
• Experience in Health Canada and FDA GMP requirements for sterile pharmaceuticals
• Working knowledge and experience with Quality Systems; along with local and global regulatory guidelines (e.g ICH, GMP, GCP and GLP)
• Professionally trained for root cause analysis including OOS and OOT using risk-based assessment tools, quality by design tools and independently troubleshoot method related problems in GXP systems
• My department at Atomvie involves the discovery, development and distribution of next generation Radiopharmaceuticals.
• The products are customized and used daily for the detection and treatment of human diseases such as cancer.

• Responsible for coordinating and directing all aspects of radiopharmaceutical Manufacturing
• Ensure that all equipment is maintained and calibrated for manufacturing and dispensing processes
• Conduct investigations into batch failures and non-conformances to identify root causes and implementation of
• CAPA's to prevent reoccurrence
• Assess production data for process development and scale-up
• Responsible for communicating with clients for supply and product delivery details; including the resolution of

product complaints and special request on short notice

• Work with managers and business development to ensure production, staffing and commercial operations are meeting financial targets for profitability
• Manage, schedule and train all staff involved in the manufacturing process. This includes ensuring that staff are adequately prepared to carry out their assigned tasks
• Maintain and keep record of inventory counts for all manufacturing processes in the facility
• Manage the receipt, quarantine, retain sampling and testing of materials related to the manufacturing of [177Lu] n.c.a. Solution for Radiolabeling
• Adhere to all GMP, Health Canada, FDA and Regulatory requirements for commercial manufacturing of clinical products
• Understand, and implement all CNSC regulations within the production facility
• Write and update SOPS, CF's and MBR's for all manufacturing processes
• Develop short term and long term plans for isotope production while keeping track of waste production and the development of new methods and strategies to minimize both cold and hot manufacturing bi-products
• Ensure that all cleaning is conducted within the facility clean rooms as per SOP's and documented as per applicable
• procedures to be in a state of GMP readiness for all manufacturing and clinical programs
• Co-ordinate and manage the logistics details for all sites receiving [177Lu] n.c.a. Solution for Radiolabeling

• Scheduled monthly production to meet the customer order and ensure smooth supply plan
• Used Minotaur ERP system for generation of work orders, production runs and inventory reports
• Issued required production records/master manufacturing documents and generated product labels
• Complete internal audit course for ISO 13485:2016/MDSAP and ISO 19011:2018(audit standards), and serves as a current internal auditor for the company
• Understanding and working knowledge of Health Canada and FDA requirements for Cosmetics and Medical Devices and regulations for importing and distribution
• Initiated and investigated deviations related to the product, procedure, equipment and operator and completed disposition of affected product and participated in design of corrective action plan and preventive action plan
• Experienced in Formulation of Rabbit plasma Coagulase and involved in antibody purification techniques
• Perform validation for new as well as for existing equipment with production supervisor
• Trained in root cause analysis including OOS and OOT using risk-based assessment tools, quality by design tools and independently troubleshoot method related problems in GXP systems
• Reviewed and updated manufacturing instructions, standard operating procedure for equipment, processing units, for necessary changes and updates reflecting current usage
• Worked in conjunction with the Production Supervisor and QC Supervisor to advise Customer Service of regular and custom orders product released for final packaging based on customer order
• Act as a bridge between production technician and production supervisor and timely delivery of trainings to technicians regarding updated SOPs, Manufacturing Instructions, and Corrective Actions following deviation / non-conformance investigation
• Mentored junior team members to enhance their technical skills and improve overall team productivity.

• Performed all duties in accordance with the applicable SOPs and company policies following Good documentation practices for the production of oral solid dosage forms
• Safely operated all equipment and machinery to process batches within specifications to meet department batch execution targets
• Performed SAP entries in a timely manner to execute a batch production
• Maintained equipment, tools and inventory of consumables and ordered needed items in a timely manner to ensure smooth manufacturing process
• Dismantled, cleaned, sanitized and assembled manufacturing equipment according to established SOPs and meet department changeover targets
• Mentored new employees in the department as per departmental requirement for equipment setup, operation, dismantling and cleaning, proper tools selection, task prioritization, pharmaceutical waste classification and documentation

• Develop and execute microbiology testing methods, interpret data, and provide insights that drive decision-making
• Accurately follow SOP's and improve SOP's as necessary
• Prepare sample for analysis by recording, weighing and blending
• Perform physical testing on QC samples
• Testing includes: Microbial Enumeration Tests, Membrane filtration, TOC analysis, Coliform testing
• Experience operating an autoclave, incubator, laminar flow hoods
• Excellent plating and streaking skills
• Pipette sample solution into tubes or plates according to the analysis process being performed
• Perform method validation/ suitability for microbiological tests, specifically bioburden and endotoxin testing