Bryanna Mareka
Raleigh
Summary
Dynamic Senior Manager with a proven track record at J&J Innovative Medicine, excelling in strategic planning and stakeholder engagement. Achieved 100% on-time launch readiness for US product introductions while leading a high-performing team. Expert in supply chain management, driving significant savings through innovative solutions and data-driven decision-making.
Overview
15
15
years of professional experience
1
1
Certification
Work History
Senior Manager, End to End Integration
J&J Innovative Medicine
04.2024 - Current
- Led a team responsible for all US new product introductions & product lifecycle management changes
- Achieved on-time launch readiness for all US product introductions through effective planning and coordination.
- Engaged internal and external stakeholders, managed resources, communicated effectively, trained teams, ensuring business readiness for product launches.
- Partnered with MSAT to establish the Kentucky DC as a launch pack & label site to accelerate speed to market for key US product launches, enabling product to patient 26 hours post FDA approval
- Led an experienced team of project management professionals responsible for high impact implementations
- Integrated Program Management into the scope of the E2E Integration team
- Influenced senior leadership on implementation strategy and acted as core Deliver team member as part of the Intracellular Integration
- Evaluated new and innovative business capabilities to drive incremental value
- Executed the Distribution Pricing Agreement (DPA) readiness and JOM Legal Entity Name Change, enabling ~$250MM in savings.
- Collaborated with DOTS to lead technical feasibility & business case development of the integrated cold chain strategy – pioneering joint Make & Deliver solutions
- Managed a team of 10+ experienced professionals, including full-time employees, contract PMs, co-ops, and GROW support
Investment Approval Process Lead (GROW Gig)
J&J Innovative Medicine
04.2023 - 04.2024
- Led the IMSC investment review and approval process managing all investment requests over $1MM
- Aligned investment requests to the IMSC global strategic priorities & ruthlessly prioritized any requests not aligned
- Established pre-approval process for investments under $5MM, enabling focused review on projects over $20MM
- Incorporated feedback and lessons learned into IRC reviews, enhancing experience for committee and presenters
- Supported development of annual IMSC G&Os, ensuring alignment of large, approved investments with strategic objectives
Manager, Customer Focused Innovation
Janssen Supply Chain
08.2021 - 04.2024
- Developed and implemented the JSC customer experience strategy through innovative solutions addressing evolving business models, market expectations, and customer needs.
- Addressed global customer unmet needs in last mile controlled-temperature shipping by integrating customer experience criteria into procurement RFP process.
- Established the team structure and operating model supporting the Global Strategy for e-labeling
- Completed packaging site assessments for all internal and external pack sites in collaboration with MSAT.
- Developed LRFP plan to convert all lines for no insert configuration.
Manager, Industrial Temperature Control
JOM Pharmaceuticals
11.2017 - 08.2021
- Oversaw temperature control for two US pharmaceutical distribution centers, ensuring compliance with regulatory standards.
- Ensured all Janssen trade products & clinical trials remained within acceptable temperature while in storage at JOM and while in transit to customers
- Protected ~$30Bn annually in product outbound to US customers
- Developed and implemented domestic and export pharmaceutical shipping risk matrices, optimizing temperature control assignments for products and lane combinations.
- Led dual site initiative to meet restrictive temperature control standards, replacing passive shipping containers with qualified reusable solutions.
- Distribution Operations and Quality core team member supporting COVID-19 vaccine storage and shipment readiness
- Resulted in total annual cost savings of $1MM+
- Achieved Lean Black Belt certification through rigorous training and examination.
- Mentored Green and Black Belt candidates from different sectors to improve their process improvement methodologies.
Senior Operations Analyst, Distribution
JOM Pharmaceuticals
03.2016 - 11.2017
- Coached associates and escalated issues to eliminate project roadblocks, ensuring timely project completion.
- Converted weekly parcel passive shippers to refrigerated truck; resulted in an annual savings of $100,000
- Consolidated multiple weekly truck routes into one weekly milk run; resulted in an annual savings of $60,000
- Drove implementation of an entirely new distribution model for Warranty Replacement free goods utilizing a voucher program
- Revised and reformatted 50+ controlled documents with a team to reduce redundancy, eliminate inconsistency, and enhance compliance.
- Resulted in a 31% reduction in number of controlled documents
- Achieved Lean Green Belt certification to strengthen process improvement capabilities.
- Recruited, interviewed, onboarded, and managed each Distribution Co-op through their 3 rotations
Operations Analyst, Distribution
JOM Pharmaceuticals
09.2014 - 03.2016
- Led backroom operations for audits, inspections, and certifications, ensuring readiness and adherence to regulatory standards
- Managed JOM Change Controls for pharmaceutical new product introduction, divestiture, and discontinuation
- Facilitated review and approval of product artwork for New Product Launches and Product Changes, streamlining processes for timely market entry
- Trained warehouse associates on lean projects and certified 15 yellow belts
- Supported KDC Operations staff in initiating, executing, and closing Trackwise CAPAs/events, ensuring compliance and operational efficiency
Technical Services Lead
Janssen Pharmaceuticals
01.2014 - 09.2014
- Led a team of 2 validation engineers in managing 50-60 equipment, facility, and utility units
- Oversaw a team of 15+ contractors responsible for performing sampling of production equipment
- Executed corrective and preventative actions to ensure optimal clean equipment performance
- Initiated actions based on analysis of sample data and trend charts.
- Developed and executed protocols for efficient start-up and shut-down of a multi-million dollar facility
- Investigated, documented, and closed 11 validation and manufacturing events/CAPAs in the TrackWise system 100% on-time
- Subject matter expert in the MHRA audit to support certification of the Janssen Bedford site for European distribution of Doxil/Caelyx
- Owned the process of cleaning and sampling production equipment used in the manufacture of bulk Doxil / Caelyx
Validation Engineer
Boehringer Ingelheim, Ben Venue Laboratories
01.2013 - 12.2013
- Designed & executed validation studies for various parenteral pharmaceuticals including both liquid and lyophilized products
- Reviewed validation sample data for conformance to final product specifications
- Reviewed equipment qualifications and performance data for controlled temperature storage and air handling units to evaluate impact of changes on validation processes
- Generated validation gap assessments to identify discrepancies during product transfer and ensure adherence to regulatory standards
- Trained operators from manufacturing and sampling departments across multiple shifts to ensure compliance with validation protocols
Process Excellence Engineer
Boehringer Ingelheim, Ben Venue Laboratories
01.2011 - 01.2013
- Conducted Failure Modes and Effects Analysis, identifying risks in hormone drug product production
- Evaluated every step in the manufacturing cycle, from receiving API through final shipment of finished good product, to determine the steps most likely to expose product
- Initiated corrective and preventative actions for high-risk areas, improving overall safety
- Led 5S+1 initiatives with cross-functional team, enhancing workplace organization
- Implemented 100+ employee-submitted process improvement ideas
- Managed a grass-roots system of collecting and implementing continuous improvement ideas
Education
M.B.A. - Executive Management
Ohio University
Athens, OH01-2018
B.S. - Biomedical Engineering
University of Akron
Akron01-2013
Skills
- Integration management
- Integration strategy
- Process optimization
- Strategic planning
- Data decision-making
- Problem-solving
- Stakeholder engagement
- Critical thinking
Certification
- FPX Project Lead Certification
- FPX Subject Matter Expert Certification
- Lean Green Belt Certification
- Lean Black Belt Certification
- JJSC Leadership Development LE2ED Program Graduate
Timeline
Senior Manager, End to End Integration
J&J Innovative Medicine
04.2024 - Current
Investment Approval Process Lead (GROW Gig)
J&J Innovative Medicine
04.2023 - 04.2024
Manager, Customer Focused Innovation
Janssen Supply Chain
08.2021 - 04.2024
Manager, Industrial Temperature Control
JOM Pharmaceuticals
11.2017 - 08.2021
Senior Operations Analyst, Distribution
JOM Pharmaceuticals
03.2016 - 11.2017
Operations Analyst, Distribution
JOM Pharmaceuticals
09.2014 - 03.2016
Technical Services Lead
Janssen Pharmaceuticals
01.2014 - 09.2014
Validation Engineer
Boehringer Ingelheim, Ben Venue Laboratories
01.2013 - 12.2013
Process Excellence Engineer
Boehringer Ingelheim, Ben Venue Laboratories
01.2011 - 01.2013
M.B.A. - Executive Management
Ohio University
B.S. - Biomedical Engineering
University of Akron