Summary
Overview
Work History
Education
Skills
Projects
Timeline
Generic

Krista Yacko

Boyertown,PA

Summary

Talented Project Manager brings proven abilities in end-to-end project management. Expert in identifying and mitigating risks, reaching milestones and managing deliverables. Highly organized leader with great attention to detail. With over 8+ years in scientific project management, I managed over 100 IQ/OQ/PQ projects with a combined revenue of over $8M in 2 years. Adept at managing customer visits, invoices, and billing across software platforms. Proficient in JDE, JIRA, Smartsheet, Veeva, LIMS, SAP, Adobe Pro, and all Microsoft Office programs.

Overview

9
9
years of professional experience

Work History

Senior Project Manager

Pinnaql
10.2023 - Current
  • Manage a team of 35 employees, ensuring all client project timelines and budgets are met.
  • Lead validation and qualification process for relocating equipment in GMP and R&D labs.
  • Ensure every project’s scientific protocols are GxP-ready for regulatory submission.
  • Streamlined project management processes by implementing agile methodologies, resulting in improved efficiency and reduced costs.
  • Implemented change management processes to accommodate evolving project requirements while minimizing disruptions.

Project Manager

Center for Breakthrough Medicine
08.2022 - 07.2023
  • Liaison for Process Development, Tech Transfer, and Clinical Manufacturing Services supporting clinical trials through commercial manufacturing.
  • Lead process development of Analytical, Upstream, and Downstream Manufacturing; aid plasmid DNA production research and cGMP grade; support viral vector production of AAV (Adeno-Associated Virus) and LLV (Lymphoid Leukosis Virus), guide teams through optimization of methods.
  • Set up custom stability, validation, and qualification programs and support clients from Pre-clinical, Phase 1 to Phase 3 for IND filing, assisting with regulatory.
  • Drive internal teams to meet client IND regulatory and administrative components within the timeline provided by reviewing protocols and ensuring the adequacy of scientific information.
  • Bridge the gap between developing and delivering clinical and marketed products.

Project Manager

PCI Pharma Services
07.2021 - 08.2022
  • Collaborate with teams including Engineering, Validation, and Production to ensure projects are progressing as planned.
  • Responsible for maintaining forecasts and managing project expenses in adherence with the project budget.
  • Generate customer invoices/billing including supporting documentation
  • Achieved over 100 IQ/OQ/PQ projects with revenue peaking at over $3M.
  • Managed risks proactively by identifying potential issues and implementing mitigation strategies, ensuring smooth project progression.

Project Manager

Rockland Immunochemicals
03.2019 - 06.2021
  • Support scientists developing custom monoclonal and polyclonal antibodies, anti-oligonucleotide and anti-idiotypic antibodies, and custom recombinant antibodies.
  • Schedule kick-off meetings with principal scientists to lay out a plan for the project.
  • Troubleshoot workflow processes or work product issues; work with the lab team closely when troubleshooting assays, capture details with the path forward or further discuss in meeting minutes.
  • Engage clients and serve as a liaison between the client solutions group, production, research, and analytical groups within Rockland acting as a single point of contact for the client
  • Managed over 500 custom projects with revenue peaking over $5M
  • Prepared detailed reports on project status for stakeholders, ensuring transparency and alignment with objectives.
  • Effectively managed scope creep by establishing clear boundaries on requested changes while keeping projects aligned with original objectives and budgets.

Project Manager

Integrated Service Solutions
09.2015 - 03.2019
  • Work directly with various Bio med pharmaceutical companies to provide calibration services including TOC, UV/Vis, and Spectrophotometer with a background in GMP, 17025 and A2LA accreditation, ISO 9001:2015.
  • Create proposals, monitor pricing with vendors, and work heavily in Excel to create financial records of products for procurement.
  • Review preliminary documentation for Quality Assurance.
  • Developed and initiated projects, managed costs, and monitored performance.
  • Increased project profitability by 20% in 3 months through improved planning and budgeting.

Education

Bachelor Of Business Administration -

Bucks County Community College
09.2010

Skills

  • Client liaison
  • Project Planning
  • Client Relationship Management
  • KPI Tracking
  • Project Close Outs
  • Risk Mitigation
  • Documentation Compliance
  • Downstream Manufacturing
  • Drug Development
  • Business Development
  • Financial Management
  • Asset Management
  • Product Lifecycle Management
  • Good Manufacturing Practices

Projects

Monoclonal and Polyclonal Antibody Production, Rockland Immunochemicals, Collaborating with Immunology Teams, I provided end-to-end support to teams creating monoclonal and polyclonal antibodies. The projects spanned over 18 months and involved 25 colleagues. Our teams developed antibodies and critical reagents for client projects in preparation for regulatory submission. 

Cell and Gene Therapy, Center for Breakthrough Medicine, Collaborating with principal scientists, I provided end-to-end support for CAR-T programs from concept to conception. I led teams to draft, write, validate, and implement personalized SOPs tailored to our client's asset. My goal was to ensure the client program was executed successfully and efficiently in preparation for regulatory submission.

Timeline

Senior Project Manager

Pinnaql
10.2023 - Current

Project Manager

Center for Breakthrough Medicine
08.2022 - 07.2023

Project Manager

PCI Pharma Services
07.2021 - 08.2022

Project Manager

Rockland Immunochemicals
03.2019 - 06.2021

Project Manager

Integrated Service Solutions
09.2015 - 03.2019

Bachelor Of Business Administration -

Bucks County Community College

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Krista Yacko