YOVANKA BOLGER

Narragansett, RI *****

EMAIL: ad4r11@r.postjobfree.com

LinkedIn URL: http:// www.linkedin.com/in/yovanka-bolger-aab75616a

401-***-****

P R O F I L E

Established Project Manager with successful experience in biotechnology, pharmaceuticals, quality control, business development, process development, engineering, and Information technology. Proven capabilities in strategy development, project management, business acumen, risk management, leading teams, financial planning and forecasting, meeting facilitation, and presentations. Technical background resulting in increased understanding of the business and financial needs, partners, and clients. Recognized for agility, leadership, partnership, driving accountability, self-motivation, and problem solving by thinking outside the box.

KEY SKILLS

Project Management, Process development/improvement, Project Portfolio Management, Leadership, Organizational skills, Bilingual (English and Spanish), Good Communication skills,

Problem-solving, influencing without Authority, Agility & continuous improvement, Strategy Development, Drug discovery & development, Risk management/assessment, financial planning, Forecasting & variance analysis, Business acumen, Quality documents/records workflow management/review-Effective, Change Control Owner/QA, Aseptic techniques, In-vivo and In-vitro Skill, computer skills (MS Project, MS office, SAP-ERP, Spotfire, TracKWise, CDOCS, Smartsheet, Excel, PowerPoint).

PROFESSIONAL EXPERIENCE

QUALITY CONTROL SPECIALIST PROJECT MANAGER

Amgen Rhode Island 2019 - Current

Project Manager and Business manager for Quality Control

Project Manager responsible for the planning (MS project), leading interdepartmental (QC, IS, PD and F&E) and cross functional teams responsible for the on time/ on budget completion of projects that support Quality operations. Provided SOW for projects, progress reports, presentations and KPIs to senior leadership.

Project Manager of cross-functional and network driven projects for new product introduction (NPI), equipment implementation/validation, method transfers, revision, remediation, comparability studies.

Project Manager responsible for the planning, management, communication with stakeholders and completion of transfer of incoming raw materials from Supply Chain to Quality organization project.

Manage Quality risks for ARI Site Operational Risk Register to ensure risk mitigation and business continuity. Reviewed and implemented crisis event playbooks and Quality Business Resiliency plans to prevent business interruption and reduce ramp-up times.

Develop and maintain Quality control project governance process, QC project portfolio management and prioritization to allow QC to be aligned with business strategies, priorities, and planning.

Forecast and monitor Quality control budget of ~$14M for controllable expenses in partnership with finance and Quality business manager.

Contract Testing Lab liaison to request SOW, quotes, budget forecasting, PO creation/invoicing (SAP-ERP) and CoA release.

Change control owner/QA for life cycle management, regulatory, compliance, equipment/asset GMP use release for lot release testing and methods revisions projects.

Managed 3rd party vendor to ensure chemical and consumable inventory maintenance.

PROJECT MANAGER

Amgen Rhode Island 2017 - 2019

Project Manager (GPS Staffing external worker) for Quality Control

Led project development and deployment of QC - Analytical Systems’ metrics (ex. deviations, Invalids) into Spotfire data lake to support operational excellence initiatives.

Drove process improvements and development of the Global Inbound Testing Schedule Tool (Global Raw Materials) SAP/ERP project to improve productivity and reduce cycle time.

Led Spotfire development and deployment for sample tracking/management to reduce cycle time and increase productivity.

Managed QC-Internal Master Schedule and projects metrics for product transfers/validation and New Products Introduction (NPI).

Supported development and deployment of Spotfire sample forecast project for QC-Technical Services.

Delivered Quality Control Leadership Team Goal Deployment metrics to support organizational goals.

Executed and reported QC-Technical Services performance metrics to support QC-goals initiatives.

Supported Kaizen Events for Quality Control improvements.

Trained and managed staff in new process improvements implementation.

BUSINESS OWNER

Catering Services Rhode Island 2013 – 2017

Ran all aspects of the catering business for four years.

Partnered with customers to understand needs and deliver products to satisfaction.

Estimated resources, budget and schedule needed for the event.

Purchased materials, planned, and scheduled deliverables.

Maintained communication with stakeholders.

PROJECT MANAGER

Bedminster Bio Energy INC. Puerto Rico 2004 – 2013

Planned, scheduled, and tracked project timelines and milestones.

Developed and delivered progress reports and presentations.

Facilitated business development and improvements meetings.

Defined the project scope, goals and deliverables that support business goals in collaboration with senior management.

Developed and delivered progress reports, requirements documentation and presentations.

Created and revised full- scale project plans and associated communications documents.

Served as the communications liaison between team members (USA-UK-PR) and contractors.

Translated meetings and documents (Spanish-English).

Staff Scientist I

Genzyme Corporation Cambridge, MA 1998 – 2004

Managed three to four projects (internal, collaborations, CRO's & international) at one time.

Projects ranged from discovery to development.

Highly knowledgeable in models of oncology, inflammation, and autoimmunity.

Experience in model and assay development, validation, implementation, data collection and analysis.

Provided accurate, innovative models and techniques in a timely manner for assay and model development.

Provided small molecules formulation development support. Facilitated personnel training for in vivo studies.

Serve as the Officer of safety and chemical hygiene for the cell biology laboratory.

Acted as a member of the Anti-angiogenesis committee for four years.

Five years of IACUC protocol writing and maintenance.

Provided detailed presentations of the studies with analyzed and interpreted data, target proximity, next steps, and timelines.

Senior Technologist, Research Department

Charles River Laboratories Wilmington, MA 1996-1998

Recognized for clear communications with responsibility of managing the Research Services Department.

Expanded capabilities at Charles River Laboratories by integrating five in vivo models.

Implemented in vivo research studies (cancer, STZ diabetic, acute and chronic toxicity

studies, PK, surgical models, neurological studies, mucositis, model, etc.). Provided compound formulation of small molecules for in vivo studies.

EDUCATION

M.B.A. Project Management - 2017- Florida Institute of Technology - Melbourne, FL

B.S. in Biology - 1995 - University of Massachusetts Boston - Boston, MA

ADDITIONAL EDUCATION

Project Management Course - Knowledge Academy (PMI Accredited)-Providence, RI

Lean Six-Sigma Yellow Belt training-Amgen RI-West Greenwich, RI

Lean Leadership training-Amgen RI-West Greenwich, RI

Working with Emotional Intelligence-Amgen RI-West Greenwich, RI

Influencing for Results-Amgen RI-West Greenwich, RI

Foundational Skills for Root Cause Analysis-Amgen RI-West Greenwich, RI

Quality Records-EVs, NCs, CAPA, ARAs, DV-Amgen RI-West Greenwich, RI

Change Control Owner/QA-Amgen RI-West Greenwich, Ri

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