Danielle Holmes

• Assisted Supervisor with Managing team: Ensuring Compliance, Accomplishing Department objectives, Timecards, Interpersonal Development Conversations and requesting Technical Trainings to advance Team Skill set
• Created Training Plans for Team which resulted in 80% of

team on average, being qualified on Fermentation operations by end of 2023 CNP campaign.
• Managing team on the floor, real time review of Batch Record entries and ensuring adherence to cGMP’s procedures are followed, (resulting on average NMT than 1 deviation per person per year)
• Facilitated clear and seamless communication among support groups, supervisor, and team members. Demonstrating effective leadership skills, resulting in timely and efficient issue resolution.
• Aided Automation/ MSAT in implementation of new recipes and skid testing. Demonstrated strong organizational skills by coordinating Non-Routine Sample Management effectively.
• Assisted supervisor in coordinating with cross-functional groups (i.e Scheduling, Engineering, MSAT, QCIP etc.) to ensure on-time production while planning support for non-routine departmental requirements
• Conducted SME reviews of SOP’s and Batch Records evaluating Documentation Edits and Process Improvements for Accuracy and Compliance
• Performed Non-Routine Protocols for 2023 CNP Contamination Investigation, working closely with MSAT contributing to root cause identification and effective corrective actions.
• Participated in leadership development courses, focusing on enhancing situational intelligence and fostering effective leadership skills.

• Large Scale process knowledge of: Fermentation, Homogenization, Continuous feed centrifugation with e.coli bacterial cell lines for both rAvPAL and CNP in a GMP environment
• Experienced with operating on PEGylation, Formulation and use of TFF/UFDF skids for protein purification and concentration Trained in Seed Lab operations including Thaw, Seed Train and Pooling Qualified in MODA for Environmental Monitoring during critical aseptic operations
• Primary instructor for Aseptic Technique course in Galli North Sterile Hood to prepare operators for Seed Train operations Extensive experience Troubleshooting equipment within given SOPs and protocols
• Represented manufacturing while interfacing with validation and process development groups including: non-routine sampling, temporary process changes through engineering runs, collecting data and communicating key observations to MSAT and PD through clinical CNP production
• Proficient use of small analytical equipment such as: YSI, GENESYS/ DU Series 730 Spectrophotometer, pH and condo meters
• Communicating efficiently and remaining flexible in a dynamic and highly team based environment with a team of 8 people Drafting and delivering shift changes and performing associated acting lead duties

• Prepared Buffer and Media for Cell Culture and Purification operations across three facilities to support multiple drug campaigns
• Served as Subject Matter expert for Preparation of Dextrose Media used for upstream operations
• Lead representative in internal MPS departmental audits Led new hire trainings for gowning and material flow techniques to comply with facility cleanroom requirements
• Created and presented new hire training classes such as Pipetting, Accuracy and Precision Following cGMP standards & maintaining audit readiness following both Biomarin and FDA guidelines