Danielle Holmes
Fairfield,CA
Summary
Experienced Professional working in the Biotechnology industry for 11 years with experience in Clinical Cell Culture Operations, Downstream Purification Operations and Commercial scale Buffer and Media Operations. Assisted in the production of drug lots that led to the commercialization of clinical stage drugs PALYNZIQ and Voxzogo. Subject Matter Expert for Troubleshooting Pegylation/ Fermentation Equipment through multiple rAvPAL and CNP campaigns for 8 years in Galli North.
Overview
12
12
years of professional experience
Work History
Associate BPS, Galli North Manufacturing
BioMarin
Novato, CA
06.2024 - Current
- Completed SME review of RVE documentation for Post Harvest Wash operations and contributed to the creation of a newly validated recipe by adhering to strict timelines for operation execution and reviewing validation protocol documentation for completeness
- Experience with initiating, triaging, investigating root cause and closing deviations in Veeva
- Authored red lines for NDT documentation revisions to bridge compliance gaps in SOP's and batch records
- Participated in site wide document archive project which organized documents in 46 Galli, 300 BMK and 90 digital
- Created PEG campaign readiness technical training and presented to GNCC teams with detailed summary of all revisions to procedures and batch record redlines during October 2025 campaign
- Led informative AGC tours through GN cell culture, providing first hand account experience with CNP fermentation operations
- Conducted data integrity testing on SK-5710 with BPS for successful RT Report implementation before PEG campaign
- SAP superuser qualified, assisted with troubleshooting SAP during implementation of the new ERP system
- Attend Tier, Process Teams and Scheduling meetings, Release SAR's and review Batch Records
Supervisor, Galli North Manufacturing
BioMarin
Novato, CA
10.2023 - 06.2024
- Provide support to floor staff including on the job training, technical support, troubleshooting production issues and identifying implementing solutions for CNP and rAvPAL
- Oversee all aspects of Fermentation and PEGylation Production including coordinating with support groups, adherence to schedule, escalation of issues to QA and Management
- Review batch records and provide manufacturing sign off prior to submission to QA with thorough documentation review
- Responsible for managing the development of direct reports by setting up monthly 1:1s to assess performance and track progress on Better Works objectives
- Conduct Year End Reviews and Coaching Conversations
- Reduced employee turnover by fostering a positive work environment and providing ongoing feedback to staff members.
- Generate deviation records using Veeva as well as executing Change Actions
- Proficient in CMMS to release SARs
- Assist team with executing Validation protocols and facilitating the training of staff to perform temporary changes in procedures for validation requests
- Ensure team executes objectives and goals while maintaining metrics that include compliance, safety and sitewide goals
- Led rAvPAL changeover planning to facilitate concurrent production in Galli North of two drug products simultaneously on tight timelines to maintain adequate supply for patients
- Conducted candidate interviews, assessing qualifications and cultural fit to select top talent for organizational needs and onboarding new hires
- Coordinated reorganization of direct reports during reorganization of GN CC teams, ensured production schedule coverage was seamless during transition
Area Lead, Galli North Manufacturing
Biomarin Pharmaceutical Inc
Novato, CA
04.2021 - 10.2023
- Led All Floor Operations and 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.
- Real time review of Batch Record entries and Ensuring Adherence to cGMP 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.
Senior Associate, Galli North Manufacturing
Biomarin Pharmaceutical Inc
Novato, CA
01.2018 - 04.2021
- 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 cond 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
Senior Associate, Manufacturing Process Services
Biomarin Pharmaceutical Inc
Novato, CA
07.2014 - 01.2018
- 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
Education
Bachelor of Science - Biological Sciences, Molecular Cellular Biology
University of California - Davis
Davis06-2014
Skills
- LIMS
- CMMS for SAR release
- Tier 1/Process Teams/Scheduling Meeting Experience
- Veeva (Deviations, Change Actions)
- Expert with Environmental Monitoring (MODA)
- SAP Superuser
Timeline
Associate BPS, Galli North Manufacturing
BioMarin
06.2024 - Current
Supervisor, Galli North Manufacturing
BioMarin
10.2023 - 06.2024
Area Lead, Galli North Manufacturing
Biomarin Pharmaceutical Inc
04.2021 - 10.2023
Senior Associate, Galli North Manufacturing
Biomarin Pharmaceutical Inc
01.2018 - 04.2021
Senior Associate, Manufacturing Process Services
Biomarin Pharmaceutical Inc
07.2014 - 01.2018
Bachelor of Science - Biological Sciences, Molecular Cellular Biology
University of California - Davis