Patrick Haley Email & Phone Number

Tustin, California

Tustin, Ca

• Direct and manage the Project Management Office that provides project management resources and risk assessment services as requested by the organization. • Accountable for oversight of client business operations, corporate initiatives, and complex cross-functional projects including management of client projects, GMP facility build-out and equipment installation, IT enterprise system implementation, and revenue recognition.• Responsible for the implementation of standardized process flows and systems to support the PMO.• Facilitates and tracks audit response requests to customers for on-time closure of records.• Supports the tracking and scheduling activities for other functions as assigned by the executive committee.• Supports and leads the activities related to corporate security including policy, procedures, and security staff.• Accountable for the successful process validation (protocol and report generation) of the internal Ph3 process.

Tustin, Ca

Irvine, Ca

• Responsible for the CMO selection, relationship management, project timelines, and budgeting with contracted CMOs to meet CMC project goals for Biologics Development. • Responsible for the negotiation of technical work packages and supply agreements with CMO partners.• Responsible for all outsourced process development work packages and outsourced generation of GMP DS to support the CMC team goals for the AGN-214868, AGN-151115/200, and AGN-150998 projects.• Implemented and managed the CMO selection, scope of work completion, technology transfers, process development, analytical development and qualification, scale-up activities.• Responsible for supporting CMC sections of IND submissions.• Implemented an internal forecasting and budget-tracking sheet for the CMC projects and BD department.• Responsible for tracking the technical performance and deliverables of the CMO, maintaining the project timelines, and updating the CMC team and CMC project plan.• Responsible for forecasting and tracking the budgets for outsourcing spend on the CMC projects.• Led a cross-functional team supporting the first level AIP (Allergan Improvement Process) on CMO Relationship management. The outcome of the activity was an updated CMO selection process and CMO scoring database.

Irvine, Ca

Irvine, Ca

• Successfully took responsibility for the CMO management of the Cell Bank release testing for the AGN-150759 project.• Worked with members of a team from multiple departments to resolve documentation issues and meet the necessary cell banking release date for the manufacturing of AGN-150759 for Allergan Biologics Manufacturing.• Managed the relationship with the CMO for the generation of GMP critical reagent to support the AGN-214868 project.• Responsible person in plan (PIP) for the ENG and GMP run to monitor technical performance and communicate deviations or issues back to the functional representatives at Allergan.• Effectively managed the relationships at CROs to facilitate the analytical development and testing needs of the CMC projects.• Updated the Outsourcing Playbook and communicated update to Senior Management within Biologics Development.

Allergan, Irvine, Ca

• Responsible PIP for upstream unit operations of drug substance at CMO during engineering batches and cGMP clinical manufacturing.• Communicated effectively with CMO to review and edit cGMP batch records and equipment procedures.• Determined real-time deficiencies in production and corrected procedural and equipment problems to ensure adherence to batch record and reduce product loss.• Led a team that utilized QbD concepts and DOE to bring drug substance technology in-house and develop phase II clinical unit operations for microfiltration, microfluidization, and depth filtration. Supported the technology transfer and manufacturing training program to produce phase II clinical material at Allergan.• Utilized risk assessment and DOE to prioritize process development experiments; allowing for reduced experimentation and improved allocation of resources.• Implemented a technology transfer training schedule and facilitated/organized classroom and hands-on trainings to the manufacturing staff.• Responsible for the scheduling and information transfer for toxicology material generation by process sciences and manufacturing teams.• Supported the development and material supply generation of select agent using platform technology knowledge from previous drug substance projects.• Experience with lean six sigma and continuous improvement methodologies.• Led a team to address the problem with cross-training on fermentation activities. Evaluated current proficiencies and bottlenecks of fermentation staff’s training level. Developed and implemented a four step training process and process flow diagram to support training on prioritized fermentation activities.• Led a cross-functional team to improve safety profile around current select agent centrifugation bottles resulting in a process flow for evaluating new materials entering the department with no prior safety history.

• Fermentation Lead -- Bacterial Therapeutic: Lead role in the development of a fed-batch anaerobic fermentation system, the subsequent scale-up, and technology transfer to a cGMP contract manufacturer for phase III clinical production.• Scaled-up the anaerobic fermentation at the 3L bench-top scale and implemented the fed-batch process up to the 3500L level. • Responsible for the technology transfer of the fed-batch fermentation to multiple CMOs.• Supervised the cGMP seed propagation and final fed-batch fermentation for phase III clinical production.• Supported multiple sections of the Chemical Manufacturing Control (CMC) section of ICH Module 3, including the BLA/MAA regulatory submission to the FDA and EMEA.• Drug Substance Lead -- Enzyme Therapeutic: Supervised the establishment of a cGMP master and working cell bank (MCB/WCB), production scale technology transfer, and the purification of a therapeutic enzyme.• Responsible for the oversight of a cGMP MCB/WCB at the contract manufacturer.• Responsible for the development, scale-up, and technology transfer of a 1000L batch fermentation process. • Authored GLP/cGMP batch records. • Supervised a four-column purification method for enzyme drug product including the in-house scale-up to 20L columns, the technology transfer to the CMO, and production of kilogram quantities of GLP enzyme.

Master'S Degree, Biological/Biosystems Engineering

Bachelor'S Degree, Biological/Biosystems Engineering