Allison P. Lynch Email & Phone Number

Rockville, Maryland, United States

Rockville, Maryland, United States

Rockville, Maryland, United States

• Designed and executed engineering run batch records in association with process development and developed cGMP processes for clients in Phase I/II/III clinical trials
• Performed aseptic cell culture, expansion, infection and transfection processes using adherent and suspension cell lines to create working and master cell banks, master viral seed stock, and final drug products
• Coordinated pre-campaign meetings with cross-functional teams to ensure alignment, and scheduling for upcoming processes to avoid potential scheduling conflicts and to confirm staff coverage
• Performed CAPA implementations and deviation investigations using root-cause analysis tools, and authored final reports for all Aseptic Processing Simulations (APS)
• Conducted after-action reviews of campaigns and executed batch records to ensure continuous process improvements streamlined future batch record revisions
• Operated as supervising person and SME in support of PiP (person in plant) through manufacturing processes, ensuring clear communication and process understanding

Rockville, Maryland, United States

• Adhered to Standard Operating Procedures (SOPs) and Master Batch Records to manufacture client-specified Phase I-III clinical drug products in ISO-5 to ISO-7 cleanroom suites
• Trained employees on SOPs and associated equipment after completion of 'Train the Trainer' Program
• Created master batch records, work instructions, and SOPs for upstream, downstream, and fill finish processes to support regulatory quality standards and fulfill client-specific process needs
• Performed aseptic best practices to ensure the controlled manufacture of vaccines: have not been involved in any contamination events

• Followed Batch Production Records (BPRs) and SOPs to manufacture human tissue products (HTPs) in ISO-5 to ISO 7 cleanroom spaces using aseptic technique for gowning and process operations
• Reviewed batch record, equipment and storage logbooks to ensure good documentation practices within manufacturing department and across quality teams
• Performed cleaning and preparation of all equipment using necessary for the daily manufacturing of HTPs using Steris Autoclave and CIP procedures
• Trained new employees on SOPs, BPRs, and aseptic gowning practices to ensure operational quality and standardization of training techniques and methods
• Mentored junior team members, providing guidance and support to foster their professional growth and development during cGMP processing and other manufacturing operations
• Prepared and kitted GMP for cleanroom processes ensuring efficient workflow and optimized manufacturing operations

• Managed and scheduled large reservations directly through guests and vendors
• Planned and scheduled events directly with guests and vendors to satisfy needs of upcoming reservations
• Filed vendor invoices and organized data via Microsoft Excel
• Collaborated with management and kitchen personnel to staff and plan events

Baltimore, Maryland

• Cared for animals in exhibits and backup tanks
• Performed water quality tests to maintain water salinity, temperature and pH
• Assisted with water system maintenance with pumps and in-house brine
• Sanitized equipment and maintained cleanliness and organization of backup areas

Westminster, MD

Master'S Degree, Biotechnology

Graduate Certificate, Biotechnology Management

Bachelor Of Arts - Ba, Environmental Biology

Activities and Societies: LEAD Program of 2015, French Club Co-President, Danger Sauce, and Ars Nova.