Zainab H. Hassen Email and Phone Number

• Oversee the development, growth and management of release and stability studies for 12 clients.• Facilitate seamless study set up through contract and study protocol development, identifying client needs and evaluates resources to effectively carry out project stages. • Monitor all project timelines, milestones, deliverables, budget, resources and scope changes • Utilize available tools, metrics and reports through study set up and closure• Coordinate and conduct meetings with external and internal clients as required to ensure project needs and timelines are met. Create meeting agendas, documenting minutes and providing status updates• Proposal scope and contract set up and review• Resource management• Oversee the final review of reports, certificates of analysis prior to client submission. • Ensure the compliance of all data with client directives, protocols, methods, internal SOPs, current good manufacturing practices (cGMP).• Develop and manage positive relationships with internal and external clients by identifying client needs and balancing client expectations within contractual obligations, corporate goals and client satisfaction. • Develop, define and monitor project schedules to meet contractual obligations. • Engage, support and direct project staff as needed to ensure timely and accurate performance of all necessary work.• Takes responsibility and ownership of overall client satisfaction, service and quality. • Streamline operations by communicating client requirements, method changes, and other relevant information to the lab, management and QC reviewers. • Collaborate with functional groups, lab management and personnel within the company to meet client requirements and project timelines.• Experience drafting QA record

• Working collaboratively as part of a team providing training to new and current employees on laboratory instruments, systems, procedures and FDA regulatory requirements. • Clearly and effectively conveyed new information and techniques to employees of all levels of knowledge and experience through presentations and hands on training• Developed, adapted and maintained training curricula and protocols• Established trust and lasting working relationships with trainees and Supervisors • Liaison between the Training, Quality Control and Lab Informatics Departments

• Ensure the compliance of all data with client directives, protocols, methods, internal SOPs, current good manufacturing practices (cGMP), and 21 CFR Part 211 by reviewing analytical chemistry data from inhalation, small molecule, and large molecule product testing.• Oversee the final review of stability reports, certificates of analysis, validation reports, and relevant data prior to QA audit and client submission for numerous clients.• Verify data integrity in physical notebooks, electronic laboratory notebooks, and system audit trails.• Streamline operations by communicating client requirements, method changes, and other relevant information to the QC team.• Collaborate with lab personnel to meet client requirements and project timelines.

Work with clinical dietitian in Radiation Oncology and Head/Neck Tumors departments.Work with patients undergoing radiation therapy and chemotherapy providing them nutritional support to ensure minimal weight loss. Help patients learn to use home feed tubing, as well as provide nutritional support for patients with special needs due to surgery or other factors. Participate in weekly Head and Neck Tumor board. Develop nutritional protocols specific for the population as well as clinical research protocols. Interact daily with doctors and nurses as a team to ensure the best outcomes for patients.

• Collaborated with senior scientists, Principle Investigators to plan, execute, research project• Maintained accurate and detailed experimental records • Developed and presented teaching material (class lectures) to an undergraduate Nutritional Science course, as well as developed quizzes, test questions and class projects. • Trained undergraduate students in research techniques, animal husbandry• Assisted in lab management and lead weekly lab discussion.

Assisted lab scientists in experimental procedures and animal care and handling. Tissue sectioning and staining, rat perfusions, chick embryo collection, among other techniques. Participated in the overall management of lab. As well as participated in, and led, weekly journal club discussions.

Adjusted USDA Grant budget, edited budget narratives, aided in planning and conducting meetings, participated in the Partnership for Public Health and Nutrition (PPHN) meeting, proctored exams, coordinated activities for state wide UW-Extension project, corresponded with grant PI’s and public health officials, reviewed news bulletin on UW-Extension website for needed updates/changes and acted as liaison between the 6 institutions involved.

Worked and gained experience in a fast-paced, high-volume hospital requiring quick thinking and action: managed patient records, properly handled hazardous body fluids, and communicated effectively with variety of professionals and patients.