Agberia A. Benard

202-***-****

ad0igp@r.postjobfree.com

EDUCATION

University of Maryland, Rockville, MD — Master of Science Biotechnology Management

SEPTEMBER 2010 - DECEMBER 2012

University of Maryland, Rockville, MD — Master of Business Management

SEPTEMBER 2010 - DECEMBER 2012

Georgia State University, Atlanta, GA — Bachelor of Science in Biology

AUGUST 2002 - MAY 2006

TECHNICAL EXPERIENCE

Biohybrid Solutions BioPharma, Pittsburg, PA — Senior Manager, Viral Vector Protein Production

June 2022 - Present

●Provides leadership guidance to the Manufacturing department, while ensuring quality of work and product are consistently being met in a complaint manner.

●Drove commissioning of all processing equipment and area as site lead for manufacturing department.

●Assisted with the design of the manufacturing area. Focusing on quality, safety, and efficiency of manufacturing operations.

●Built a highly functioning diverse MFG team by hiring 20 manufacturing staff to meet an aggressive production schedule.

●Manage a high performing team of 25 staff including 2 supervisors.

●Continue to drive 100% success rate of PPQ Batches within the year.

●Provide guidance on design for the upstream MFG schedule. Maintained +/- 2hrs schedule adherence for 99% critical operations.

●Identified and implemented the use of Single-Use Disposables to improve current Manufacturing processes and drive-up process improvement by 95% success rate.

●Modeled multiple run rates to project staffing and equipment utilization.

●Led “No contamination in MFG Area”, by implementing aseptic operational training and utilizing human performance tools.

●Manage Tier-3 collaboration meetings with all Senior Leadership Teams (SLT) to drive key performance indicators (KPIs), issue resolutions and communication across site.

●Provides leadership guidance throughout the Protein production team by implementing a culture of innovation, collaboration, and operation excellence amongst team members.

●Develop, implement, and monitor performance measures and continuous improvement of technical integration and externalization utilizing data analysis and visualization tools and platforms within manufacturing.

●Oversees timely deliverance of products to internal and external customers.

●Developed leaders on the team through routine 1:1’s and direct on the floor mentoring.

●Author, review and approve batch records, protocols, and direct SOPs for site use when applicable.

●Maintain safety, regulatory and compliance standards as they relate to current manufacturing practices.

●Implement department policies and work practices related to manufacturing readiness; provide communication and training of policies to all manufacturing staff.

●Implement safety measures throughout manufacturing to mitigate against workplace accidents, and loss of work time by more than 90% success rate.

●Manage change controls.

●Drive collaboration and coordination amongst various functioning groups to facilitate the planning, the establishment of set goals, milestones & deliverables, and set comprehensive timelines within manufacturing.

●Implement continuous improvement projects within manufacturing to mitigate against human errors and rework with a success rate of 85%.

●Assess and collaborate with senior manufacturing team members on production issues and vulnerabilities.

●Continue to implement inspection readiness of all manufacturing areas.

●Participate in on time review and closures of major or minor investigations, CAPA’s, deviations, and Quality reports.

●Responsible for all Quarterly and Annual reports for Manufacturing.

●Perform department performance reviews and goal management for manufacturing department. As well allocation of Budget appropriately.

Biohybrid Solutions BioPharma, Pittsburg, PA —Program Manager, Protein Production

October 2021 - Present

●Oversees outsourcing activity of external contractors including protocol transfer and protein production

●Oversees process development, ensuring production, performance and quality of work are consistently met.

●Ensures all internal and external activities align with statement of work.

●Drive collaboration and coordination across functions to facilitate the planning process, the establishment of set goals, milestones & deliverables, and the comprehensive timelines.

●Work with Chief Financial officer to develop operating budget.

●Drive continuous improvement on protein production up to 95% yield.

●Build working relationships within BHS team and external stakeholders.

●Work collaboratively with scientists on the Analytical Development, Bioconjugation synthesis and preclinical work.

●Actively contributes to and assure the effective execution of, science-driven, phase appropriate, and risk-based process development strategies to support development program for the CDMO business.

●Coordinate and implement production protocols to decrease human error and rework to more than 65%.

●Author, review and approve batch records and direct SOPs for site use when applicable.

●Review, identify non-conformance issues, and take part in investigation and CAPA Activities.

●Author, coordinate and review all Monthly, Quarterly and Yearly reports pertaining to the production of protein.

●Provide risk evaluation support and actively monitor and manage BHS program issues and risks, by working with the program teams to track and evaluate potential risk to the overall process and mitigate the risk.

●Deliver high quality progress and technical reports to executive team members as requested.

●Reviews process descriptions and batch records during tech transfer.

●Assists with long-range operating goals, expansion efforts, and new advanced technology implementation.

●Identifies and shares training opportunities for staff to build and improve skills.

Takeda BioPharma, Social Circle, GA —Manager, Manufacturing Operation Readiness-Albumin.

September 2020 – October 2021

●Implement manufacturing operations readiness strategies and oversight compliance in collaboration with Manufacturing sciences, Engineering, Quality and Supply chains in accordance with Takeda Manufacturing expectations.

●Responsible for department performance reviews and goal management for team. As well allocation of Budget appropriately.

●Develop, implement, and sustain operational readiness activities including establishment of manufacturing procedures and standard practices that decreased human or process errors by more than 85%.

●Coordinate with safety, environmental control, and various cross-functional teams on developing efficient working schedules.

●Increase human performances and learning efficiencies on the floor shop by more 80%.

●Communicate expectations, schedule adherence, and monitor progress, provide guidance and deliverables in a timely manner.

●Directs oversight of strategic partners, including CRO, CMOs and internal partners to ensure study plans, timelines and operations are aligned.

●Monitor and Verify implementation of Takeda controlled documents for CMOs work.

●Coordinate/Lead meetings internally and with CMOs

●Lead and participate in investigations as related to manufacturing process. Author deviations, non-conformances, CAPAs, and change controls as required. Partner with quality, compliance, Engineering, supply chains, and MS&T.

●Safety champion on site.

●Participate and support the selection, commissioning and qualification of equipment and automation for Manufacturing.

●Manufacturing approval, author and review of approved batch records and direct SOPs for site use when applicable

●Cross functional collaboration with support groups to provide expertise on identifying problems of advance scope where my analysis of situation allows recommendation to resolution to gaps in manufacturing or change further stop of occurrence of issues.

Takeda BioPharma, Social Circle, GA —Manager, Quality Assurance-Fractionation

August 2019 – September 2020

●Establish, implement, and sustain an operational quality oversight in compliance with Takeda quality expectations.

●Participate in coaching, Mentoring and development of staff for adequate performance of job function.

●Support supervision of floor production coverage compliance activities for fractionation areas.

●Execute performance reviews, budget and goal management for Quality team.

●Led and engage in continuous improvement projects to boost production efficiency through various quality streamlining by more than 80%.

●Participate in electronic batch records review, identify non-conformance issues, take ownership in investigation and CAPA Activities.

●Championed work-place safety improvements to remove actual and potential hazards to increase site safety to 95%.

●Author, review and approve batch records and direct SOPs for site use when applicable.

●Led and engage in continuous improvement project for site EBM system to increase fractionation process efficiency by more than 50%.

●Managed external and internal relationships between Quality operations, Quality systems, Manufacturing, Engineering and Auditors to ensure adequacy and appropriateness of site product specification.

●Responsible for coaching and training for quality department as well as reporting progress.

●Manage Tier-1 & 2 collaboration meetings between quality and manufacturing to drive key performance indicators (KPIs), issue resolution and communication across site.

●Support and Led implementation of quality strategies from project leads as applicable.

●Responsible for standardizing and trending the continue process authorization (CPA) of finished bulk product for site.

AstraZeneca, Frederick, MD —Senior Process Lead, Upstream Cell Culture Manufacturing

March 2017 – August 2019

●Supervise/lead day-to-day production, scheduling, staffing, material management, compliance, training, and auditing activities for upstream areas.

●Direct on floor shop support for manufacturing execution, investigations and Corrective and Preventive Action (CAPA) executions.

●Trend process performance and data trending to assess batch performance.

●First line of defense for process and equipment troubleshooting on shift.

●Coordinate and implement the use of PAS-X electronic batch record system and recipes in manufacturing.

●Responsible for driving the execution of standard work and reporting progress.

●Responsible for managing Tier-1 & 2 meetings in manufacturing area to drive key performance indicators (KPIs), issue resolution and communication across shifts.

●Responsible for embedding Operational Excellence (OE) principles in manufacturing including standard work, 5S, visual management and tier meetings.

●Lead and engage in continuous improvement projects.

●Knowledgeable in the use of single use disposable technology in manufacturing.

●Author, review and approve batch records and direct SOPs for manufacturing use.

●Experienced in the use of Electronic Batch Record Management systems.

●Review electronic batch records, identify non-conformance issues and participate in investigation and CAPA Activities.

●Final review of completed manufacturing documentation per compliance standards and established timelines.

●Participate in GEMBA walks to identify waste and ensure process improvement opportunities.

●Participate in QA multi-site projects as a contributor.

●Daily supervision and performance of on-the-floor operations pertaining to biologics manufacture in a cGMP environment.

●Collaborate with supervisors and leads to resolve problems, identify root cause, and proposing process or scheduling improvements through clear communication to senior management in team meetings.

●SME in SAP transactions for product scarping, cycle counts in manufacturing, material reconciliations during and after each run.

AstraZeneca Medimmune, Frederick, MD — Senior Production Technician III

DECEMBER 2013 - MARCH 2017

●Supervise/lead the day-to-day production, scheduling, staffing, material management, compliance, training, and auditing activities for area of responsibility in upstream.

●Drive manufacturing operational readiness deliverables to ensure successful campaign completion.

●Identify and implement improvement initiatives to enhance product yield, reliability, and/or process robustness through leading and/or implementing change controls.

●Conduct and teach the business needs to lower-level associates and support group regarding the manufacture of biologics.

●Qualified in the manufacture of clinical and commercial drug biologics that meet regulatory requirements of both domestic and international markets.

●Expert and qualified trainer in the operation of production equipment in multiple areas in small to large scale, and manual & automated bioprocess plants.

●Knowledgeable in the use of Delta V, PLC based process control systems, and Human Machine Interface (HMI) configuration.

●Accurately analyzes and processes scientific data.

●Work with manufacturing support groups to identify gaps in operations and implement procedures to correct problems.

●Lead the continuous improvement implementation of safe working environment in upstream in accordance with current industry OSHA guidelines. Collaborate in the mitigation of any health risks.

●Lead and serve as “subject matter expert” in unit operations.

●System expert in implementing Bill of Material (BOM) in SAP for daily process transactions, TECO and confirmation of all work order assignments.

●Participate in internal or external audits as SME for department.

●Demonstrate continuous improvement with respect to increasing job knowledge and proficiency related to the biopharmaceutical industry, as well as technical understanding/problem solving capabilities.

●Coordinate with Facilities and supervisors in tracking and the closures of Work Orders in SAP in a timely fashion within key manufacturing IT system such as SAP.

●Author and revise SOPs GMP/Commercial Manufacturing records. Drive manufacturing deliverables to ensure successful commercial operations.

●Proficient in the use of Aegis to author and revise GMP documentation and manufacturing records (Batch records, SOPs, change controls, etc.).

●Responsible for training junior staff members on process related manufacturing activities.

●Provide input into performance evaluations of production technicians when needed.

●Mentor others on process operations, domestic and international regulatory compliance.

●Routinely monitors manufacturing processes and recognizes potential process issues as they arise; proactively escalates identified issues to management team.

●Troubleshoots problems and recommends potential solution to all manufacturing support groups/management team.

●Contributes to the development of new concepts and techniques.

●Participates in the tech transfer process of new products to manufacturing areas.

●Identifies and supports the implementation of process efficiencies and areas for continuous improvement.

GlaxoSmithKline, Rockville, MD — Senior BioPharm Manufacturing Associate

JUNE 2012 - DECEMBER 2013

●Assign daily tasks to production technicians pertaining to manufacture of biological based products.

●Drive manufacturing operational readiness deliverables to ensure successful clinical start-up.

●Supervision of production technicians during process related activities.

●Conduct relevant processes, cGMP and safety training.

●Lead CAPA investigations to adequately identify root cause and implement appropriate corrective and preventative actions to prevent reoccurrence.

●Interface with other departments to help resolve issues related to equipment, process and compliance including facility support departments and external vendors.

●Coordinate with planning and facility on specific production work order that builds for materials resource planning system in microbial upstream.

●Provide input into integration and validation of new equipment and processes.

●Owner of the implementation of new equipment, systems and/or procedures.

●Knowledgeable on the current Code of Federal Regulation (CFR).

●Lead/participate in technical reviews, investigations and process improvement projects in order to meet objectives.

●Advanced equipment knowledge to perform first line troubleshooting and root cause analysis during processing and investigations.

●Demonstrates a proficient scientific knowledge and understanding of manufacturing processes in core area.

●Sufficient knowledge of processes, systems and equipment to troubleshoot problems.

●Very adaptable to various shift needs and dynamics.

●Responsible for training of junior staff.

●Lead unit operations and/or projects.

●Serves as the SME in unit operation for Microbial Upstream operations.

●Contributes to the development of new concepts and techniques within the Microbial upstream team.

Human Genome Sciences, Rockville, MD — Manufacturing Associate III

FEBRUARY 2008 - JUNE 2012

●Operation of bioprocess equipment under strict adherence to cGMP, OSHA, and policies and regulations.

●In-direct supervision of production technicians and training of colleagues on relevant processes, cGMPs, and safety.

●CIP and SIP of product tanks.

●Review and execution of related documentation relating to processes.

●Assist with technical issues, identify deviations and participate in investigations.

●Assist with problems of moderate scope where analysis of situation or data requires a review of identifiable factors.

●Lead resolution of technical and process issues, initiate change control for equipment/process modifications.

●Monitor and audit work processes to ensure compliance and completion of targets.

●Draft and revise SOPs and batch records as necessary.

●Work on problems of advanced scope where analysis of situation or data requires a review of identifiable and unknown factors.

●Monitor and audit work processes to ensure compliance and completion of targets.

●Assist and lead closure of process deviations, investigations and corrective actions.

●Participate in the tech transfer process of new CMO products into the Microbial manufacturing area.

●Identify, develop and implement process improvements, equipment improvements/upgrades.

●Provide process ownership through timely actions related to equipment supplies, required maintenance/repairs, process concerns, safety concerns, and areas of improvement.

●Perform sampling/in-process testing supporting the manufacturing and validation process for current processes as well as developmental work for new products/processes as required.

●Work with hazardous materials under the appropriate safety procedures.

●Routinely monitors manufacturing processes via DARTS and recognizes potential process issues as they arise; proactively escalates identified issues to senior staff and management.

●Receive, stage and track materials.

●Competent in UF/DF Processes.

●Qualified trainer in the operation of production equipment in multiple areas in a small scale, semi-automated and manual bioprocess plant such as, bioreactors, centrifuges, depth filtration, tangential flow filtration, autoclaves, biological safety cabinets, column packing equipment, and instrumentation pH, conductivity, UF/DF, Mass spectrometer, YSI, Vicell etc.

SKILLS

20+ Years of GMP Manufacturing and Quality Operation Experience

Situational Leadership

Matrix Leadership

GMP’s, FDA, EU Regulations

Effective Decision Making

Effective Communication

Cost Analysis

Gene Therapies

Gap Analysis

CDMO

Lean Six Sigma

Program Management

Operational Management

Project Management

Operational Excellence

Deviation Management

Root Cause Analysis

Technology Transfer

Process Improvement

Change Control

Aseptic Techniques

Leadership & Mentoring

SOP & Batch Record Authoring

Cell Culture Processes

UF/DF Processes

EXPERTISE

Software Applications LIMS Systems, QUMAS, Trackwise, SAP, ERP, EBR

Microsoft Office- Word, PowerPoint, Excel, Exchange, MS Project, etc.

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