Kirkland Graham
Microbiologist
Atlanta,GA
Summary
I am a results-oriented professional renowned for my proficiency in quality assurance, manufacturing operations, and process enhancement, boasted over a decade of experience in the pharmaceutical and biotechnology sectors. My adeptness lies in ensuring meticulous adherence to industry standards and regulatory protocols. Having overseen the production of regulatory starting materials, intermediates, and API to meet clinical trial material requisites and facilitate commercial process validation, I demonstrate exemplary leadership. I possess a commendable track record in instituting and upholding resilient quality control mechanisms. I have collaborated closely with QC Microbiology, managing bioburden samples and TSA plate samples. Charged with the aseptic processing of clinical and commercial phase products adhering to cGMP standards, I executed my responsibilities with precision. I conducted testing of raw materials, in-process materials, and formulation samples to bolster production efforts. I storied career includes adept management of quality control processes, ensuring the delivery of high-Caliber products in alignment with regulatory requisites. With oversight of the directional flow of deviations, investigations, root causes, CAPAs, and their timely closures, I ensure efficiency and effectiveness. I am a local candidate and is available to start on 2 weeks’ prior notice. Start-up experience including OQ and PQ. Perform daily operations associated with large scale cell culture up to 20,000L production bioreactor. Possess a working knowledge of bioreactors, continuous flow centrifuge and depth filtration equipment.
Overview
20
20
years of professional experience
1
1
Certification
Work History
Manufacturing Operations Manager (Contract/Consultant for CSL Behring)
Black Diamond Network
01.2025 - 06.2025
- CGMP practices, Processing Engineering, FDA-GMP, Federal & State Regulatory Compliance, Plant Operations, Resource Planning, Manufacturing Operations Management and Instrumentation Drawing, Piping and Instrumentations Drawing (P&ID) Leadership, Sterilization, Lean Process Improvement, Molecular Microbiology, Cell Therapy, Clinical Monitoring, Global Regulatory Compliance, Drug Development, Customer Satisfaction, Quality Auditing, Import/Export Operation, Operations Fermentation Process Development, Communication, Project Management, Engineering Design, Continuous Improvement, Troubleshooting, Biotechnology Industry, Biologics, Product Development, Bacterial Cell Culture, Production Planning, written communications Good Clinical Practice (GCP),and
Cell Culture Supervisor, Manufacturing Specialist (Contract/Consultant for CSL Behring)
Black Diamond Network
01.2024 - 01.2025
- Oversee and managed day to day activities of the Manufacturing Cell Culture Group.
- Responsible to lead deviations and investigations related to manufacturing operations.
- Review deviations, non-conformances, and CAPAs as required.
- Teamed up with Quality and other cross functional groups to address issues effectively and compliantly.
Quality Assurance Operations Specialist Fractionation (Contract/ Consultant for CSL Behring)
Black Diamond Network
04.2022 - 01.2024
- Assisted with investigating deviations that were relevant to the area of responsibility.
- Participated in Fractionation VS investigation meetings/working sessions for QAO Fractionation, along with other supportive external groups.
- Participated in the necessary research to determine root cause, corrective & and preventive actions, and product disposition, and used the investigation tools provided by QAO management.
- Worked jointly with Manufacturing personnel to perform root cause analysis at the time of deviation occurrence and assisted with determining robust corrective & and preventive actions.
Quality Assurance Specialist Deviation Backlog (Contract/ Consultant for CSL Behring)
Black Diamond Network
12.2021 - 04.2022
- Conducted Quality Assurance-level reviews and dispositioned deviations and investigations.
- Approved and/or worked for the improvement of investigations to meet expectations.
- Performed QA approval for minor, major, and/or critical deviations.
- Worked remotely from home and communicated with QAO managers to discuss and resolve deviations, investigations, and CAPAs.
- Conducted real-time batch record reviews for accuracy, completeness, and conformance to procedures and specifications for batches executed on the manufacturing floor.
Sr. QC Associate Chemist (Contract/ Consultant for Piramal Solutions)
Carlton National
11.2021 - 12.2021
- Conducted testing of raw materials, in-process materials, and formulation samples in support of production.
- Performed the inspection and disposition of raw materials, packaging components, and parts in support of production.
- Performed tasks according to approved SOPs, methods, and procedures within compliance with cGMP, FDA regulations, and Corporate Quality Policies.
- Maintained QC Analytical Laboratory in compliance with regulatory standards and site procedures.
- Documented and Reviewed Analytical Data and Laboratory records accurately, completely, and promptly.
- Conducted lab investigations and special analytical projects, as assigned.
- Completed and participated in training activities, as assigned, to perform job responsibilities and maintained up-to-date analytical skill sets and practices.
- Participated in continuous improvement activities looking to pursue laboratory best practices and offer appropriate feedback when non-value-added activities are observed.
Business Account Manager (Contract/ Consultant)
Brighter Health & Primary Care Medical Practice
01.2021 - 12.2021
- Managed COVID control and health services platforms among staff organizations.
- Owned the growth of the Mavenlink B2B marketing system while facilitating product and platform collaboration between external medical providers and internal teams.
- Understood and communicated market opportunities, trends, needs, and medical partner feedback to the medical provider.
- Developed beneficial and trusting relationships with medical provider partners to make Kareo a favored company to partner with.
- Defined partnership strategies and executed go-to-market plans.
- Maintained B2B client relationships.
- Experienced in developing first-of-a-kind, strategic deals that are creative and align business incentives with great user experiences.
- Managed all cost control and financial budgeting.
- Maintained excellent communication with patients, clients, and vendors.
Quality Assurance Manager (Consultant/Contract)
Qualgen Inc.
07.2019 - 11.2021
- Participated in outsourced API manufacturing processes.
- Solved potential manufacturing process challenges.
- Had oversight of the manufacture of regulatory starting materials, intermediates, and API in support of clinical trial material requirements and commercial process validation.
- Oversight of regulatory starting materials and API process development and manufacturing activities are conducted in compliance with good manufacturing practices and applicable regulatory requirements by proactively assisting in oversight of processes.
- Reviewed API and batch records, analytical methods validation plans, process validation plans and protocols, and manufacturing campaign reports.
- Prepared technical reports, a co-assisted pharmacist in charge of patent applications content, publications, and oral presentations as necessary.
- Communicated progress and strategy in various forums including reports, and presentations as necessary.
- Batch record review, approval, and product disposition.
- Approved and reviewed testing and stability data in support of the release
- Provided external audit support, and participated in all audit activities, from audit scheduling, preparation, audit execution, and audit closeout.
- Oversight of directional flow of deviations, investigations, root causes, CAPAs, and closures of all are done effectively and promptly.
- Expertise with QMS improvements for small- and large-scale systems.
Upstream Cell Culture Supervisor
Oncobiologics CMO Inc.
01.2018 - 07.2019
- Aseptic processing of clinical and commercial phase products for cGMP standards.
- Managed small and large-scale cGMP processes and a clean-room environment (Class 100/10,000 /100,000).
- Trained junior personnel to analyze processes and troubleshoot equipment for issues.
- Reviewed and corrected MBRs related to QA questions regarding batch record execution and disposition.
- Led the operation of all equipment for clinical and commercial operations, (CIP systems, bioreactors single-use and stainless steel, Historian systems, SAP, Trackwise, and TFF filtration skids).
- Communicated with the team to ensure daily operations within the planned schedule were equally delegated.
- Oversaw 20 direct reports for a 12-hour graveyard shift, while working with cross-functional departments across different shifts.
- System owner and area person of contact for projects to be carried out throughout assigned shifts.
- Communicated accurate shift notes to the next shift supervisor.
- Prepared and presented run data for technical support project meetings.
- Coached, mentored, and developed staff.
- Worked closely with Process Development for technical support and transfer of technical data from Pilot to Clinical Supply, and finally to the commercial scale.
- Met aggressive production timelines and various performance metrics for clients.
- Facilitated and interacted with cross-functional departments such as QA, QC, Engineering, and Validation.
- Worked with team to ensure gap analyses were performed about risk to resolve any issues for corrective actions promptly.
- Identified process improvement where needed and implemented a change control for process and or product to maintain good business.
Upstream Cell Culture / Fermentation / Aseptic Process Simulation Fill Supervisor (Consultant/Contract)
Cytovance Biologics
01.2019 - 06.2019
- Worked with other MFG supervisors, managers, and project managers to execute production schedules promptly.
- Furnished daily updates to production managers, client representatives, and program managers.
- Performed work that consisted of independent decision-making and the exercise of independent judgment and discretion.
- Championed manufacturing production areas and associated equipment.
- Acted as liaison with MST, and process development groups to assist with tech transfer, scale-up, and translation activities.
- Worked closely with QC Microbiology, submitting bioburden samples and TSA plate samples.
- Interfaced with the Quality Control department to coordinate environmental monitoring as needed.
- Interfaced with the Quality Assurance group to ensure completeness of GMP documentation, and triage.
- Represented the department to interface with clients and on cross-functional project team meetings.
- Furnished guidance to the Aseptic Process Simulation personnel.
- Made sure all requirements related to regulations were met within the (media fill simulation) procedure and practices.
- Worked closely with QA and MFG regarding investigations for deviations that affect the Aseptic Process Simulation during the execution of fills and or inspections.
Upstream Processing Supervisor
CMC Biologics CMO
02.2015 - 01.2018
- Worked with Process Engineer to ensure P&IDs were correct.
- Reviewed Validation Protocols.
- Ensured training of new hires was completed in CMC Biologics Launch Facility.
- Ensured proper staffing of the Upstream Cell Culture area.
- Aseptic processing of clinical and commercial phase products for cGMP standards.
- Managed small & large-scale cGMP processes in a clean-room environment (Class 100/10,000 /100,000)
- Trained junior personnel to analyze processes and troubleshoot equipment for issues.
- Reviewed and corrected MBRs related to questions regarding batch execution and disposition.
- Led the operation of all equipment for clinical and commercial operations, (CIP systems, bioreactors single-use and stainless steel, Historian systems, SAP, Trackwise, and TFF filtration skids).
- Communicated with a team to ensure daily operations within the planned schedule were equally delegated.
- Oversaw 20 direct reports for the 12-hour graveyard shift, while working with cross-functional departments across different shifts.
- System owner and area person of contact for projects to be carried out throughout assigned shifts.
- Communicated accurate shift notes to the next shift supervisor.
- Prepared and presented run data for technical support project meetings.
- Coached, mentored, and developed staff.
- Worked closely with Process Development for technical support and transfer of technical data from Pilot to Clinical Supply, and finally to the commercial scale.
- Met aggressive production timelines and various performance metrics for clients.
- Facilitated and interacted with cross-functional departments such as QA, QC, Engineering, and Validation.
- Worked with team to ensure gap analyses were performed about risk to resolve any issues for corrective actions promptly.
- Identified process improvement where needed and implemented a change control for process and or product to maintain good business.
- Teamed up with clinical manufacturing and process development to identify trending metrics for process improvement and provided data promptly within meetings.
- Prepared mid-year and year-end reviews for staff about performance.
- Selected team members for developing the team and trained the team on interpersonal skills for internal and external communications.
- Participated in the budget development process; effectively controlled the controllable expenses (OT, and Supplies) within their influence.
- Track and drive CMC-related quality items closure on time investigations, deviations, CAPAs, and change controls.
Manufacturing Production Supervisor Gilead Sciences
Oxford Corporation
07.2014 - 01.2018
- Aseptic Fill Finish Department (Contractor)
- Had daily contact with Compliance, Inventory Control, and TFF Maintenance to ensure equipment and materials were ready and available for use.
- Possessed investigation skills and knowledge of Good Manufacturing Practices.
- Demonstrated strong knowledge of FDA and cGMP standards.
- Was in charge of ordering raw materials, and disposable consumables, and creating BOMs for GMP batch records.
- Worked closely with upstream process engineers to evaluate and execute engineering runs.
Production Supervisor Prolong Pharma
The Judge Group
09.2014 - 02.2015
- Aseptic Fill Finish Department Downstream (Contractor)
- Trained and provided guidance to junior staff, coached, and mentored.
- Maintained clean room behavior within compliance with cGMP standards.
- Edited Mastered Production Records and Standard Operating Procedures as needed to accurately reflect process steps and capture process changes.
- Filtrations with 10KD, 50KD, and 300KD TFF Depth filtration skids.
- Operated a 415 Bio-Flow Fermenter System
- Oversaw a Red Blood Cell Wash aseptic sterile process.
Cell Culture Roller Bottle Manufacturing Supervisor/ Scientist
Shire HGT Biopharmaceutical
11.2013 - 07.2014
- Oversaw a sterile large-scale roller bottle cell culture process.
- Participated in Cell Culture-related process improvements and process transfers alongside process development.
- Managed capital projects that improved cell culture manufacturing processes' robustness that supported company goals.
- Effective leadership includes individual goal setting, performance reviews, and managing the development of employees.
Spinal and Biologics Supervisor
Medtronic, Inc.
12.2012 - 11.2013
- Made recommendations for improvements related to quality, setups, operations, and system procedures, while accurately documenting problems and solutions.
- Monitored the quality, efficiency, and effectiveness of assigned personnel and overall manufacturing performances and associated metrics within their department.
Upstream Processing Manager/Sr. Scientist
Laureate Biopharmaceutical CMO
10.2011 - 10.2012
- Scheduled production campaigns for multiple-size stainless steel stir tank bioreactors.
- Communicated with contract clients, for trends that were appropriate for monitoring the performance, and identifying resolutions to assess appropriate metrics.
- Ensured compliance was within cGMP and other regulatory requirements.
- Drafted, reviewed, and approved specifications, SOPs, non-conformance reports, manufacturing batch records, IQ/OQ/PQ protocols for cleaning equipment, deviations, and corrective actions.
- Managed and coordinated initiatives for new pharmaceutical processes.
- Led the Cell Culture group to act as a liaison between process development by communicating requirements, and standard specifications.
- Assisted Process Development maintaining timelines for the development and discovery of new drug products for different cell lines to support clinical and commercial manufacturing resolve deviations by presenting trending data reports within a timely manner.
Commercial Manufacturing Cell Processing Supervisor
Dendreon Corporation
06.2010 - 09.2011
- Led the development, planning, implementation, and maintenance of manufacturing methods, processes, and operations for new and or existing products and technologies.
- Scheduled 25-62 employees for cGMP night shift processes.
- Worked closely with Quality groups to always ensure strict compliance with cGMP guidelines.
- Made recommendations for corrective actions necessary to ensure conformity with quality specifications.
- Ensured finished products conformed to company standards and satisfied GMP regulations.
Commercial Manufacturing Cell Culture (Sr. Scientist)
Imclone Systems Incorporated
10.2005 - 06.2010
- Provided project management and manufacturing expertise for the commissioning of Train #1 and Train #2 cell culture inoculum preparation area.
- Led process development and technical transfer from R&D to clinical supply to commercial scale, meeting aggressive production timelines and various performance metrics.
- Facilitated and interacted with cross-functional teams, overseeing technical process transfers from process development to clinical pilot plant operations.
- Managed the start-up of various projects to completion and received various performance and leadership awards for process improvement projects.
- Facilitated the release of a 350,000 ft2 commercial manufacturing facility for final Good Manufacturing Practice (GMP) use.
- Conducted training for clinical operators in GMP standards for clinical Phase I administration and demonstrated leadership in developing associates to manage the qualification and implementation of a new operations suite.
- Trained others to write, review, and approve technical documents through approval processes and developed associates to manage change requests through completion.
- Facilitated investigations through problem-solving to final corrective actions for various atypical events.
- Trained associates to design experiments, interpret data, and implement change management.
- Ensured strict compliance with GMP, GTP, and safety standards, maintaining and monitoring various performance metrics such as clinical supply demand, safety, and training.
- Managed and facilitated the implementation of a new cell therapy suite, including equipment and process implementation, equipment commissioning and validation, and retrofit of associated equipment and processes into pre-existing areas. Formulated a new training curriculum for the new process and associated procedures.
- Participated in a Pre-Approval Inspection (PAI) for the commercial release of a new product, providing systems and opportunities for associate growth and training.
- Worked within a cross-functional team to initiate investigations for deviations, mechanical and personnel errors, and process and automation issues, implementing and monitoring safe, efficient, and robust processes.
Education
Bachelor’s - Chemistry, Biology
Claflin College
Orangeburg, SCSkills
- Excellence Project Management Skills
- Implementing GMP operations from development through commercialization
- GMP Quality Trainer
- Inspection/Pre-Approval Inspection/Audit readiness
- Policies, Procedures, and Batch Record Writing
- Investigative and problem-solving skills
- Knowledge of FDA regulations and GXP guidelines
- Excellent organizational, interpersonal, and decision-making skills as well as written communication skills
- Provide regular updates to Quality Assurance in support of monthly reporting and metrics generation
- Monolayer antigen production processes
- Fermentation bioreactor operations
- Process observations for process improvement
- Back-log deviations/ CAPAs
- Internal/External Audit experience
- Process Validation/Technology Transfer
- Process Optimization for in-process samples, process validation, and stability sampling and tracking
- Managing multi-shift Upstream/Aseptic Fill process operations
- Single point liaison with Quality Assurance/ Process Development
- Experience with reviewing and dispositioning GXP and GMP materials
- Tracking, authoring, and closing all related investigations, deviations, and CAPAs
- Liaising with Quality Assurance on internal and external investigations
- Deviations, CAPAs, risk assessments, process change controls
- Filling lines, lyophilization
- (GCC) Global Change Control delegate
- Computer Skills: Microsoft Office: Windows, Excel, PowerPoint, Access, Outlook
- Manufacturing operations management
- CGMP compliance
- FDA regulations
- Lean process improvement
- Project management
- Quality auditing
- Sterilization techniques
- Instrumentation drawing (P&ID)
- Continuous improvement initiatives
- Clinical monitoring
- Regulatory compliance
- Cell culture processes
- Data analysis for decision-making
- Material requirements planning
- Health and safety compliance
- Quality management
- Productivity improvement
- Facility management
- Production planning
- Waste reduction
- Environmental compliance
- Manufacturing process design
- Lean tools implementation
- Manufacturing technologies
- Strategic thinker
- Team supervision
- Material handling expert
- Data analytics
- Assembly line production
- Problem-solving
- Time management
Accomplishments
- Hired start-up Mfg Staff
- Developed all Start-up cGMP Training Classes
- Worked with CMC Biologics Quality Assurance to start an extensive Video Training Program which led to Online Training
- Participated in CMC Biologics Launch Facility PAI working with Quality Assurance and was instrumental in FDA approval of new manufacturing facility.
Certification
- Skill Path Supervisor and Manager
- Dale Carnegie for Manager's and Supervisors' leadership
- Lean Six Sigma
- Kaizen; (5S)
Professional Highlights
CMC/Biologics operations professional with exceptional experience in the development of biotechnology products. Over 20 years of experience managing mammalian, microbial, and GMP manufacturing of recombinant proteins intended for clinical studies and commercial markets. Expertise in 21CFR211, cGMP & ISO 9000 audits, PAI/FDA Inspections, and project management, technical resources for Manufacturing and Engineering. Provide guidance in the areas of single-use bioreactors, and stainless-steel stir tanks, storing and tracking, cleaning validation compliance, CMC incident investigation and resolution, troubleshooting, coordinating multiple start-up projects, technology transfer, and optimizing multiple production campaigns with the control and sample disposition of multiple samples for batch release, validation protocols, and stability engineering projects. Direct, develop, and mentor employees to ensure the overall success of the team. Added value to the team, by leading, supporting, coaching, mentoring, and providing insights. Made recommendations for changes within Production that supported process improvements. Established and championed initiatives to ensure process development, implementation, compliance, and sustainment. Lead scientific projects to test clinical, and pilot procedures that contribute to departmental goals and reflect development processes. Supervised Cell Culture Commercial and Clinical manufacturing operations in the organizations 10,000 ft2 and 250,000 ft2 multi-product facility. Lead a staff of 10 operators engaged in the production of monoclonal antibodies for clinical and commercial drug bulk product at the 11,000 scale.
Personal Information
Availability: Available to start on 2 weeks’ prior notice., Local candidate
Languages
English
Professional Working
Timeline
Manufacturing Operations Manager (Contract/Consultant for CSL Behring)
Black Diamond Network
01.2025 - 06.2025
Cell Culture Supervisor, Manufacturing Specialist (Contract/Consultant for CSL Behring)
Black Diamond Network
01.2024 - 01.2025
Quality Assurance Operations Specialist Fractionation (Contract/ Consultant for CSL Behring)
Black Diamond Network
04.2022 - 01.2024
Quality Assurance Specialist Deviation Backlog (Contract/ Consultant for CSL Behring)
Black Diamond Network
12.2021 - 04.2022
Sr. QC Associate Chemist (Contract/ Consultant for Piramal Solutions)
Carlton National
11.2021 - 12.2021
Business Account Manager (Contract/ Consultant)
Brighter Health & Primary Care Medical Practice
01.2021 - 12.2021
Quality Assurance Manager (Consultant/Contract)
Qualgen Inc.
07.2019 - 11.2021
Upstream Cell Culture / Fermentation / Aseptic Process Simulation Fill Supervisor (Consultant/Contract)
Cytovance Biologics
01.2019 - 06.2019
Upstream Cell Culture Supervisor
Oncobiologics CMO Inc.
01.2018 - 07.2019
Upstream Processing Supervisor
CMC Biologics CMO
02.2015 - 01.2018
Production Supervisor Prolong Pharma
The Judge Group
09.2014 - 02.2015
Manufacturing Production Supervisor Gilead Sciences
Oxford Corporation
07.2014 - 01.2018
Cell Culture Roller Bottle Manufacturing Supervisor/ Scientist
Shire HGT Biopharmaceutical
11.2013 - 07.2014
Spinal and Biologics Supervisor
Medtronic, Inc.
12.2012 - 11.2013
Upstream Processing Manager/Sr. Scientist
Laureate Biopharmaceutical CMO
10.2011 - 10.2012
Commercial Manufacturing Cell Processing Supervisor
Dendreon Corporation
06.2010 - 09.2011
Commercial Manufacturing Cell Culture (Sr. Scientist)
Imclone Systems Incorporated
10.2005 - 06.2010
Bachelor’s - Chemistry, Biology
Claflin College