diana baelly

Participation in research studies involving optimization of drug delivery via antibody-targeted liposomes to cancer cells. Ran various assays including phospholipid determination, small scale chromatography with various gel media, SDS-PAGE electrophoresis, HPLC optimization, spec scans. Additional responsibilities: participation in grant proposal writing, coordination of sample delivery overseas and between facilities.

Responsibilities focus on support for commissioning and qualification of a new biopharmaceutical fill/finish facility. Responsibilities include: design and implementation of environmental monitoring in the aseptic filling/lyophilization loading isolators, creation and implementation of aseptic techniques within the isolators, design of media fill challenges to support equipment sterile hold times, smoke study support, and participation in electronic batch record design. Additionally, perform closure of complex discrepancies for new equipment and electronic batch record review for the new filling process. Qualified to perform AQL during product vial inspection; trained to identify the nature and types of vial defects.

Assessed environmental control requirements for filling area shutdowns, including in-process and return to service cleaning and monitoring. Created and summarized media fill protocols, approved and closed Quality Control environmental excursion discrepancies. Provided product quality impact evaluations and necessary cleaning requirements for product-associated environmental deviations (HVAC, Environmental Monitoring and microbial recoveries). Assessed change records (CRs) for environmental impact, redlined QA documents and performed Quality Approval of manufacturing documents. Initiated/completed change records and CAPAs for Quality/Environmental issues. Participated in fill line smoke studies.

Filling MQA group Lead; primary Quality point of contact for issue notification/resolution during Clinical and Commercial production. Performed real-time oversight of bulk/filling production activities, facility compliance walkthroughs, and approval for shutdown restarts. Reviewed batch records for accuracy and completeness. Assessed, summarized and closed deviations. Provided technical and procedural training to new Reviewers/Associates.

Performed batch record review of Manufacturing Batch records for accuracy and completeness. Generated deviations for nonconforming events identified during the review process. Consumed/reconciled materials in SAP, issued batch records, and performed SOP revisions. Trained new personnel on Good Documentation Principles.

Responsible for purification, formulation and bulk filling of biopharmaceutical contract products in a multi-product facility (Pexelizumab, Betaseron, and Meningitis-C). Performed changeover activities to assemble and disassemble equipment between campaigns, and supported inter-process cleaning validation through rinse/swab sampling of process contact equipment. Packed and tested purification chromatography columns. Executed viable air and surface environmental monitoring during production, and performed bioburden sampling of WFI drops.

Responsible for preliminary purification/large-scale separation and final formulation of recombinant product Betaseron. Packed and tested purification chromatography columns, performed cleaning verification of process tanks via swab and rinse sampling, and performed WFI drop bioburden sampling. Performed viable air and surface environmental monitoring during production. Used SAP to manage goods issuance, movement, and stock (cycle) counts.

Performed oversight of the HTO Media Fill Program. Authored site-specific SOP for Media Fill and Smoke Study Programs, which defined and in some cases redesigned program elements (personnel qualification, sterile hold time challenges) to facilitate adherence to regulatory (FDA, EMA, PMDA, etc) and corporate requirements. Assessed environmental impact and controls for facility work and plant-wide shutdowns. Served as a Subject Matter Expert (SME) for compliance audits, presented content to regulatory auditors from a variety of countries, and created content/participated in FDA training events to demonstrate site procedures (isolator operation, media fills). Served as a technical resource for discrepancy evaluation pertaining to environmental concerns, in addition to closing parent discrepancy records. Initiated, approved and closed change records.

QA oversight of environmental and utilities monitoring, cleaning and pest control programs, and facility shutdown/restart processes. SME on environmental issues- root causes and remediation for microbial excursions. In 2 years have reduced site EM excursions to less than 50% of prior levels through implementation of appropriate controls. Chair of site Environmental Monitoring Team, a cross-functional collaboration tasked with identifying risks and improvements for maintaining classified space cleanliness and environmental integrity. I routinely present to international regulatory authorities (e.g. EMEA, FDA, Korea) on topics including facility controls (e.g. cleaning, material movement, pest control), environmental/utility monitoring, and process deviations. I have also designed and overseen the execution of several studies to establish, improve and simplify cleaning/EM programs.