Gregory Shell, Ms, Pmp Email & Phone Number

Newberry, Fl, Us

Fargo, North Dakota, Us

Waltham, Ma, Us

Waltham, Ma, Us

The Project Manager (PM) applies project management knowledge, skills, tools, and techniques to meet client requirements and accomplish project objectives within the Program Management department at Brammer Bio, LLC, the best-in-class cell and gene therapy contract development and manufacturing organization (CDMO). The incumbent will be the primary client point-of-contact and will lead project teams through each project stage from initiation to closing, in adherence to project management industry standards and in accordance with biologic and pharmaceutical development and manufacturing industry guidance and regulations. Monitor and control execution of project work relative to the project plan and lead project team through the successful and timely completion of each phase. Communicate project requirements and progress, address client and stakeholders need and requests, resolve project issues, and mitigate risks to objectives and deliverables. Organize and facilitate meetings and conference calls with clients and internal stakeholders and create and maintain client communication records, project logs, schedules, agendas, minutes, and lessons learned. Create project plans for new projects and change orders including scope, schedule, and/or cost baselines. Identify need for change orders to the agreed scope of work and collaborate with commercial development team on change order generation and tracking. Participate in and/or organize prospective client visits as requested by management. Serve on site team(s) as requested or recommended by management.

Seal Beach , Ca, Us

March 2014 – Present, Process Engineer, Dendreon Corp. Union City, GAManage key project portfolio across Dendreon’s manufacturing sites. Develop, plan, and prioritize with senior leaders to ensure proper FTE and budgetary coverage across portfolio.Work with project leads to ensure proper tracking, feedback, leadership oversight, and accountability of project status.Lead projects with varying scope from conception through post-implementation evaluation.Provides 24/7 support for both routine and complex deviations. Assesses deviations for product impact and root cause determination using a variety of tools including review of primary data, technical reports, patient history, trending reports, and regulatory information.Generates protocols and reports to support process improvement, process validation and new equipment validation activities at the IMF.Assists with technical transfer activities for processes and methods being transferred to or from the IMF.Interacts with site and corporate functions to assess the scientific, regulatory, and business impact of process improvement initiatives. Assists in the management and implementation of approved process improvement projects at the IMF.Authors, owns, or assesses change controls related to changes to processes at IMFs.Participates in regulatory inspections as needed.

Seal Beach , Ca, Us

• Led cross-departmental projects relating to the GMP manufacture of product• Aseptic manufacturing and assembly of clinical and commercial human blood derived components in a clean-room environment (Class 10,000/ISO7, and Class 100,000/ISO8). • Weighs, measures and checks raw materials to ensure batches manufactured contain proper ingredients and quantities.• Helps in validating processes and equipment that are directly related to filtration, cleaning and sterilization. • Maintains records to comply with regulatory requirements and acts as subject matter expert for revisions or improvements to manufacturing documents.• Works with other Cell Processing Associates utilizing good manufacturing practices during aseptic processing of clinical and commercial products using Standard Operating Procedures.• Oversees gowning and basic clean room supply stocking.• Mentors and trains new Manufacturing Associates.• Represents department in cross-functional teams, projects and GXP-related problem resolution.• Compose and process Exception Reports, SOPs, and CAPAs.

Us

* Led cross departmental projects to increase efficiency* Maintaining lab inventory* Maintaining solution inventories* Created inventory system to track and quantify cell processing media* Mixing and batching of solutions for use in clinical process* Receiving samples from clinical trial sites for processing* Maintenance and cleaning of equipment* Cell viability and counts* Shipping finished product* Label requests, printing, and reconciliation.* Revise SOP’s for manufacturing

Kennesaw, Ga, Us

* OSHA Compliant* ISO 13485:2003 Standard Compliant* Compliant under QSR: 21 CFR Part 820* Clean Room Experience (class 10,000)* Good Manufacturing Practices* Good Tissue Practices: cGTP-21 CFR parts 16, 1270, and 1271* Good Documentation Practices* TPL Safety Committee member

Master Of Science (M.S.), Conflict Management

B.S., Biotechnology