Ken Reilly Email & Phone Number

San Rafael, Ca, Us

• Lead the Supply Chain Operations function including management of staff in the delivery of responsibilities in a compliant and safe manner. • Monitor, analyze, and forecast storage space requirements for materials, equipment, and other items across BioMarin and third-party sites. • Coordinate with Logistics the movement of materials, products, and equipment between third party storage facilities, campus sites, and contract filling sites. • Lead and / or participated on diverse projects within Supply Chain Operations to improve compliance, reduce risk, and increase efficiencies.• Primary SCO representative for internal and external audits/inspections.

San Rafael, Ca, Us

• Manage upstream production personnel and activities to effectively support manufacturing needs to meet company requirements/goals for the commercialization of ROCTAVAIN (first Gene Therapy product for severe hemophilia A).• Develop and sustain the manufacturing team as a quality-minded culture driven by focusing on outstanding compliance and continuous improvement activities that support business objectives. • Primary manufacturing representative for internal and external audits related to the Gene Therapy MFG facility.• Manage and lead the upstream Process Team core members to ensure high-level performance for their area in terms of safety, quality, cost, supply, and continuous improvement.•Reco gnized accountability for all aspects of the Process Team results and own the change and improvement agenda for the Process Team. • Worked closely with direct line functional managers of process team members to ensure appropriate development plans are in place and aligned with site and functional goals

San Rafael, Ca, Us

San Rafael, Ca, Us

• Manage upstream production operations and personnel to effectively support manufacturing needs to meet company requirements/goals for existing commercial products.• Develop and sustain the manufacturing team as a quality-minded culture driven by focusing on outstanding compliance and continuous improvement activities that support business objectives. • Recognize and appreciate employee contributions and support workforce diversity.

San Rafael, Ca, Us

Cambridge, Ma, Us

• Supervise upstream production personnel and activities to effectively support manufacturing needs to meet company requirements/goals for existing clinical and commercial products.• Lead and facilitate daily IWT meetings related to KPI, roadblocks, error traps, observations and the manufacturing process schedule • Drive manufacturing team to achieve established targets for Safety, Quality, and Productivity by using HU and 6S tools• Ensure that daily production schedules are met, manufacturing procedures are followed, and all direct reports are trained on current procedures.• Manage and evaluate direct reports performance on a consistent basis in a written performance review. • Develop and sustain the manufacturing team as a quality minded culture driven by focusing on outstanding compliance, continuous improvement activities that support business objectives. • Complete manufacturing review and sign off for GMP documentation (Batch Records, SLR’s, logbooks), generate deviations, CAPA, change controls as required. • Participate in internal and external audits as a primary manufacturing representative. • Perform basic troubleshooting and resolution of floor and production observations as required. Elevate issue to QA and direct management as required. • Adhere to standard operating procedures (SOPs), revise procedures as required for content and/or annual review. • Manage and oversee all operations associated with: Cell Culture operations including thaw, Inoculation, bioreactor Prep and Harvest• Review and approve validation protocols for upstream manufacturing

• Responsible for daily operations on the production floor, including scheduling, staffing, training, material use and troubleshooting to ensure that all operations are in full compliance with applicable MBRs/FPs, SOPs, and safety guidelines.• Effectively managed employee performance issues and corrective actions• Recognized and appreciated employee contributions and support workforce diversity• Created and owned deviations or investigations of various complexities and work with cross functional departments to evaluate root cause, close them and implement appropriate corrective actions.• Supervised/Oversaw Cell Culture and Central Services manufacturing operations for the production of clinical and/or commercial products

Basel, Ch

•Provide leadership and developmental opportunities to staff; establish a strong coaching/mentoring relationship with direct reports.•Responsible for the performance appraisal process of Direct reports.•Serve as the lead trainer on manufacturing processes and all related equipment.•Maintain professional and positive interactions with client representatives

Paris, France, Fr

• Ensured work environment meets Genzyme and industry standards. Participate in the development of safety goals and manage operations so that all site goals are met. • Managed the performance planning and development process for all direct reports. Coordinate department level hiring and staffing plans. • Worked with the Quantic group on investigations and root causes for minor and major deviations using the Track wise data base.• Coordinated and reviewed all validation RQ’s and PQ’s related to Equipment Prep validated equipment• Implemented the roll out of the weigh and dispense process for support services.

Cambridge, Ma, Us

• Lead operator for Production support activities• Perform validation on Carboy washer/stainless steel tanks• Member of the Manufacturing Safety Team.• SME for all Production Support activities• Lead operator for third shift Production Support.• Perform assembly, cleaning, sanitizing, and steaming of production equipment for the Manufacturing Process.