Danyelle Barber, Mba, Mph, Pmp Email and Phone Number

Interact with contract manufacturing organizations (CMOs) and contract research organizations (CROs) to complete pre-clinical, IND-enabling, and Phase I activities. Conduct and coordinate review of technical documents and reports from manufacturing, as well as coordinate meetings with clear agendas and accurate minutes. Risk management through continual assessment, monitoring, and tracking. Development of mitigation plans and necessary escalation where required. Managing project progression throughout the program life cycle using timeline management, maintaining visibility of objectives, and regular gated milestone reviews. Confirm vendors adhere to the communication plan with necessary members of the team. Integrate deliverables and dependencies between vendors seamlessly.

Assistant Project Manager works as primary contact for newly awarded and existing genomics projects. Primary responsibilities include overseeing the project to ensure on-time, quality deliverables, navigating spreadsheets and databases for project tracking, identifying and resolving project issues, and identifying areas for process improvement and working with teams to implement needed change.

Quality Analyst I, Micro is responsible for performing daily lab operations with the assigned functional area related to the release of product, and/or monitoring of the IMF environment, as well as complete other assigned duties. Performs routine environmental monitoring, including air viable, particulate, viable surface sampling, and purified water system sampling/testing. Performs assays for qualifying raw materials and for release or stability testing of in-process and finished products. These test methods may include flow cytometry, ELISA, endotoxin, complete blood count, viability, gram stain, growth promotion, and sterility. Receives and maintains traceability and integrity of test samples, reagents and materials used in the laboratory per approved procedures. Initiates and takes ownership as needed of laboratory investigations and exception reports for out-of-limit samples, and of other projects and related assignments. Performs routine laboratory equipment maintenance. Revises and updates standard operating procedures. Performs testing in support of method validation studies. Adheres to good documentation practices to ensure data integrity and traceability

Laboratory Specialist supports the Center for Disease Control and Prevention (CDC) National Center for Immunization and Respiratory Diseases (NCIRD) Influenza Division (ID) in the areas of laboratory operations, analysis and research. This position provides essential expertise for monitoring drug susceptibility of viruses collected worldwide for the diagnosis of influenza resistance to antiviral drugs.Maintains accurate records of materials/reagents used to conduct laboratory analysis. Maintains batch records and certificates of analysis for viruses, RNA, inactivated antigens and ferret antisera. Works with team members to maintain records for internal and external distribution of reagents. Uses independent judgement in the use of Influenza Division quality management systems for quality control assurance of reagents distributed by the team. Maintains and renews shipping import permits. Prepares/coordinates outgoing shipments with CDC’s shipping department. Maintains a database of shipments sent and received. Communicates shipping costs/invoices to administrative assistants.

Leading and supervising sanger sequencing and storage stability to ensure efficient and effective of the suite at all time. Support the Quality team and Auditors in maintaining: ISO 9001 Quality System requirements, EU (Directive 2003/94/EC) and USA (CFR 21 Part 210/211) current GMP regulations and HTA regulations 21 CFR Part 11 regulations – FDA guidelines for electronic records and electronic signatures, ICH Topic Q1A (R2) – Stability Testing of New Drug Substances and Products, and ICH Topic Q1B (R2) – Photostability Testing of New Active Substances and Medicinal Products. Reporting of all out of Specification incidents, deviations and Customer Complaints to the Quality Assurance Officer in accordance with SOPs. Ensuring peripheral equipment (e.g. data loggers, elgas, etc) is operational at all times. Preparation and completion of all relevant documentation and data acquisition systems

Key responsibilities and duties include but are not limited to: Replying to routine inquiries from customers of Source BioScience and providing technical support to the commercial department. Performing all aspects of DNA sequencing and genomic services including: handling samples, managing high workload and maintenance of instrumentation. Extracting DNA, processing DNA samples for Sanger Sequencing, as well as other research projects. Observing and identifying problems with possible hardware faults or reaction contamination. Performing quality control checks in order to maintain accurate and up-to-date laboratory records following GDP and GLP standards. Continuously monitoring chambers to provide a regulatory compliant facility with conditions that meet ICH guidelines. Advising sales team of laboratory procedures in order to assist with pricing. To carry out all work to specified standards directed by professional/regulatory bodies including the Institute of Biomedical Scientists (IBMS), Health Professions Council (HPC), Clinical Pathology Accreditation (CPA) and MHRA Good Laboratory Practice (GLP)