CMO Program & Project Manager: Results-oriented Program / Project Manager with extensive experience directing all aspects of the biotechnology manufacturing lifecycle; expertise in end-to-end contracted program and project implementation within Contract Manufacturing Organization (CMO). Launch client manufacturing operations and cGMP processes to ensure delivery of top product quality and achieve maximum revenue generation. Adept at laboratory, project,
CMO Program & Project Manager: Results-oriented Program / Project Manager with extensive experience directing all aspects of the biotechnology manufacturing lifecycle; expertise in end-to-end contracted program and project implementation within Contract Manufacturing Organization (CMO). Launch client manufacturing operations and cGMP processes to ensure delivery of top product quality and achieve maximum revenue generation. Adept at laboratory, project, and operational team leadership, training, and performance management.
Senior Manager Manufacturing @ From March 2014 to Present (1 year 6 months) Frederick, MDProgram Manager @ Hold responsibility for leading complex CMO, partnered, and internal programs within the Manufacturing Operations organization. Coordinate and manage contractual obligations with functional managers (Manufacturing Operations, R&D, Quality, Supply Chain, Commercial Operations, Accounting, Finance, etc.) to ensure timely completion of milestones. Monitor and report on overall progress of the program and its’ associated milestones and lead the internal and external core team meetings to ensure adherence to the contractual work plans. Facilitate joint project meetings and program oversight meetings. Selected Contributions: • Key interface and Program Manager for three major CMO (Biologics) programs resulting in • Key interface and Contract Administrator for government contract • Chair/Lead Client specific Joint Steering Committee with executive leadership teams to coordinate program oversight • Chair/Lead client specific Joint Project Team • Served simultaneously as BDS Lead, CMC Lead, and Program Manager for a CMO program, seamlessly managing ongoing scope creep; successfully achieved all project From August 2012 to March 2014 (1 year 8 months) Rockville, MDSenior Project Manager @ Hold responsibility for contract manufacturing organization (CMO), collaboration, and internal commercial program planning, management, and implementation, directing project teams and collaboration among internal / external stakeholders. Coordinate with diverse operational departments and functional managers, including Manufacturing Operations, Product Development, Quality, Supply Chain, Commercial Operations, and Accounting / Finance. Facilitate joint project meetings and provide executive-level program and project presentations. Selected Contributions: ** Spearhead key aspects of business development, including development of RFI / RFP proposals, project requirement analysis, and preparation of statement of work (SOW) documents. ** Lead project planning for integrated manufacturing deliverables, creating milestones, WBS, and status dashboards supporting ramp-up of manufacturing, supply chain, and quality processes; establish post-launch performance tracking and analysis tools for supply and manufacturing KPIs. ** Drove implementation of 3 major programs resulting in an additional $50M in revenue. ** Assumed collateral role as Bulk Drug Substance (BDS) Lead, directing process innovations such as BDS Campaign Lessons Learned, resulting in streamlined technology transfer processes and formal Standard Operating Procedure (SOP). ** Served simultaneously as BDS Lead, CMC Lead, and Project Manager for CMO implementation, seamlessly managing ongoing scope creep transforming project from routine effort to major initiative; successfully achieved all project objectives, including internal revenue generation goals and client drug production / delivery goals. From December 2009 to August 2012 (2 years 9 months) Rockville, MDSenior Supervisor - Techincal Training @ Transitioned into technical training program leadership role, coordinating clinical and commercial manufacturing training for 12 departments across 3 facilities. Played instrumental role in development of cGMP-aligned training program vision and strategy within Training and Development Committee. Developed classroom-based, Web-based, and video courses, instructional content, materials, and testing tools. Managed training team of 4. Selected Contributions: ** Directed the HGS Shut Down training program for twenty associates over two month period, providing training in basic elements of biotechnology equipment such as bioreactors and purification columns/skids. ** Implemented Technical Training Dashboard enabling transparency into technical training deliverables for all stakeholder departments. From 2008 to December 2009 (1 year) Rockville, MDSenior Supervisor - Manufacturing Operations @ Earned swift promotion from manufacturing support to supervisor then senior supervisor role within Manufacturing Operations, overseeing phase III production and recovery operations in 1600L-scale Mammalian Cell Culture and 750L-scale Microbial Fermentation facilities. Performed production forecasting and managed related employee recruiting, hiring, training, and performance management; provided training in operational processes and internal policies to comply with state / Federal regulatory requirements. Supported inspections and regulatory audits. Supervised shift of 6. Selected Contributions: ** Performed extensive cross-functional collaboration, liaising across Product Development, Technology Services, Metrology, Engineering, Validation, Process Control, Production Planning, Materials Management, Safety, QA / QC, Project Management Office, BDS Sub team, and CMC Team. ** Transitioned manufacturing from 2 to 3 shifts, reassigning 20 associates and 2 supervisory colleagues. From 2002 to 2008 (6 years) Rockville, MDResearch Associate I - Manufacturing @ Transitioned from temporary employee through LabSupport to permanent role, performing research and lab support within 250L- and 600L-scale mammalian cell culture manufacturing operation. From 2000 to 2002 (2 years) Gaithersburg, MD
Bachelor of Science (B.S.), Biochemistry and Molecular Biology @ University of Maryland Baltimore County From 1995 to 2001 Allen Bolden, PMP is skilled in: PMP, Recruiting, Global Alliance..., Business Development, Collaboration, Contract Management, Contract Manufacturing, Six Sigma, Training Delivery, Supply Chain, Operations Management, Team Building, Contract Negotiating, Conflict Resolution, Performance Management, Project Management, Program Management, Cross-functional Team..., Biotechnology, Leadership, Lifesciences, GMP, Life Sciences
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