Michael Salgado Email & Phone Number

Los Angeles, Ca, Us

• Responsible for the overall performance of the Fill/Finish department. • Accountable for delivering on a very dynamic production schedule to meet customer demand.• Internal and external audit representative for Drug Product manufacturing. Perform onsite vendor (CMO) quality assurance audits. Generate and submit final audit results/report to vendor (CMO).• Manage budget expenditures and financial oversight for the Drug Product department to support business strategies and initiatives.• CMC product specific governance team member. Support team as Drug Product SME and Author supporting new product IND (Investigational New Drug) filings.• Address compliance gaps by owning or supporting CAPAs, TACs, and Change records or responding to compliance audits.• Tasked with owning and project managing with various stakeholder's, new product introductions (NPI) and tech transfers via our quality system.• Establish strategic department goals and objectives that align with company expectations. Develop, support and report KPI's to demonstrate performance of the Drug Product department.• Assigned to lead complicated projects/initiatives around the qualification of new equipment and GMP processes. The timely completion of these projects/initiatives allow us to start production runs on clinical and commercial products.• Member of the Senior Site Leadership team, collaborate with other cross functional leaders on various high-level initiatives and strategy planning activities.• Member of selection committee assigned to meet with various vendors (CMO’s) and select best fit for our Drug Product business need. Review/editing of SOW (statement of work) and MSA (master service agreement) contracts.• Technical SME for Drug Product manufacturing. Responsible for working with vendor (CMO) on knowledge process tech transfer, implementation (engineering runs), and final approval.

• Accountable for coordinating the daily, weekly, and monthly Drug Product activities to meet a demanding production schedule.• Improved and rebranded the media fill program to successfully execute/qualify a new production fill line.• Collaborated with Manufacturing Associate Director to create department goals and objectives that align with company expectations.• Developed, supported, and reported KPI's to demonstrate performance of the Drug Product department.• Created and sponsored a business-critical cross functional daily coordination team responsible for escalating /mitigating issues, coordinating equipment and parts logistics, and bringing alignment to the master production schedule.• Addressed compliance gaps by owning or supporting CAPAs, TACs, and Change records or responding to compliance audits.• Tasked with owning and project managing new product introductions (NPI) and tech transfer via our quality systems.• Support complex equipment issues, ensuring for timely resolution (minimizing impact to operations), by supporting ongoing troubleshooting, and follow through on long term asset changes.• Implemented SQDEC, Gemba walks, visual boards, and weekly scrums to standardize work, improve communication, and drive quick change/improvements.• Manage, recruit, develop, train, and mentor individuals to build a highly functional DP team. Provide guidance for career development and professional progression.

• Tasked with leading a newly formed team within the Facilities & Engineering department.• Responsible for creating the vision and key accountabilities for the Technical and Compliance team to best serve the business needs.• Manage 12 direct reports through various complex assignments, all while remaining focused on people development through strategic career planning.• Accountable for all planning, coordination, implementation, and troubleshooting aspects of the SSFP Drug Substance and Drug Product GMP Facility Shutdowns.• Creation and implementation of team visual boards focused on safety, quality, delivery, engagement, and cost.• Propose and lead the initiative to proactively reduce the maintenance activity scope for SSFP facilities with planned upcoming production discontinuation.• Accountable for leading the transformation of important compliance programs related to inspection readiness, maintenance strategies, and vendor oversight and facility fitness.• Coach direct reports through rapid Kaizen sessions for cost-saving initiatives and improve business processes within the Reliability and Facilities and Engineering department.• Address compliance gaps by owning or supporting CAPAs, TACs, and change records or responding to compliance audits.• Responsible for owning two global documents that governs our right to operate within approved calibrated and validated system parameters.• Use predictive maintenance technology and software to evaluate signals and make decisions regarding maintenance and/or repairs.• Work with direct reports to project management Capital (CAPEX) and Non-Capital projects and safety projects.