Charles Brawley USAF

Experience

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  TCell

  Jan 1993 - Jan 1993

  QC Associate (Intern)
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  Charm Sciences, Inc.

  Jan 1993 - Jan 1997

  Manufacturing Shift Supervisor
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  Millennium Pharmaceuticals

  Jan 1998 - Jan 2001

  Clone Processing Leader

  Responsible to lead a team of 6-7 associates to produce cDNA libraries. Developed employees and supervisors. Utilized Kathrin Greer Associates to teach leadership development skills. Transformation of bacterial cDNA libraries and phage libraries, Ligations, cell culture, plating, high throughput colony picking, sequencing, capillary sequencing, liquid dispensing.Investigated and implemented capital automated systems. Performed technology transfer from Millennium patformto Cereon Genomica (Monsanto). Implemented barcoding systems and collaboarted tom develop LIMBS systems. Developed batch records SOP's and training systems. Impemented a second shift to meet capacity needs. Introduced cGMP to the neew department. Show less

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  Alkermes Pharmaceuticals

  Mar 2001 - Mar 2008

  Manufacturing Team Leader

  Team Leader (Manufacturing Supervisor) responsible for leading two shifts (10-12 direct reports). Developed objectives and goals for teams members which performed formulation, spray drying, encapsulation, and operational support (media, autoclave, parts cleaning). Responsible for safety, training Isotrain, deviation and CAPA resolution Trackwise, leveraging TQM and six sigma techniques to improve and implement quality systems on the manufacturing floor maintaining quality (cGMP) and improve cycle efficiency. Developed and implemented batch records and SOP. Management preventative manitenance schedule. Operational excellence, culture building, and continuous improvement. Interacted with Regulatory, QA, Facilities, and QC. Performed cGMP training. Show less

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  Braintree Labs

  Apr 2008 - Dec 2010

  Manufacturing Manager

  Manage several approved product lines, tableting, encapsulation, and liquid formulation. Responsible for plant operations, cGMP training and compliance, CAPA, safety, Reporting directly to the Plant Director.

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  Genzyme Biologics

  Jan 2010 - Jan 2011

  Genzyme Manufacturing Supervisor Cell Culture Purification

  Supervised a staff of 6 technicians to manufacture 2000L Fabrazyme: TFF, ANX columns, Zinc columns, SP Column, UFDF, Nano Filtration, lg Scale buffer prep for columns. Purification. Six Sigma, FDA remediation of process and documents, Plateu Training management. Mentored existing counter shift staff and supervisors on cGMP and supervision.

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  Bio-Techne

  Feb 2011 - Apr 2020

  The responsibilities of this position are to direct and manage four different groups; the antibody/ protein finishing, manual and automated filling teams, bulk inventory team, and packaging teams. Implements strategic goals, develops and maintains the budget and capex requirements, directs departmental/company policies, monitors performance, provides performance feedback and annual performance reviews. Manages programs to identify and develop automations programs, implements automation (IQ/OQ/PQ), validates equipment and software, across divisions. This position will lead the Biotech Division’s Lean Six Sigma Team. Additionally, this position will be a key member of the GMP Facility Steering Committee. This position monitors compliance and engages regulatory agencies, CAPA, complaints, deviations, safety, and training compliance. Show less Was responsible for all aspects of plant management, leader development, and safety; Formulation (blood, plasma, glucose coagulation, blood gas), Fiill/Finish; and packaging operations. Antibody protein purification, high speed automation, and robotics, Development of training, employee development, manufacturing efficiencies and metrics; cGMP, CAPA, NCMR, Customer complaints, Safety, Product tech transfer, new products.Managed and developed formulation leader, packaging leaders and Fill/Finish leaders. Utilized college levels classes, seminars, and external leadership development experts (Giombetti Associates) to develop leaders. Show less

  • Sr Manager Operations Bio-Techne

    Jul 2018 - Apr 2020

  • Manufacturing Plant Manager

    Feb 2011 - Jul 2018
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  Tapemark Pharmaceuticals

  May 2020 - Nov 2021

  Sr Manager Operations

  Provide day-to-day leadership and direction for production teams and Mfg Compliance department to ensure excellence in execution (GMP), product quality, and safety. Established leadership development programs. Appropriately budget, manage, and allocate production personnel across two buildings and across two shifts. Leverage trained resources to meet the production schedules. Champion an environment of safety, innovation, lean continuous improvement, and adherence to GMPs and GDPs. Leverage an understanding of each process to generate reports and drive change where possible, affecting change.Key Results Areas:As the leader of the Manufacturing production teams, you oversee the day-to-day operations to ensure the pharmaceutical products produced at Tapemark meet both internal and pharmaceutical quality standards. This includes but is not limited to:Developing and executing on production schedules that meet customer (internal and external) timelines and expectations. This includes understanding all Tapemark manufacturing processes and critical product attributes.Ensure manufacturing processes and resources are utilized in a reliable, effective, and efficient manner.Managing production staffing levels and coordinate, with production planner and Plant Production Manager, the allocation of personnel and resources.Direction of manufacturing staff across three shifts.Strong collaboration with Quality, Engineering, R&D, and Project ManagementWork collaboratively to drive to 100% training compliance, implement and direct a Compliance group.Hands-on leadership in non-conformance and CAPA investigations related to production. Drives continuous improvement efforts.Ensure manufacturing production is in compliance with FDA regulations, OSHA requirements, and internal Standard Operating Procedures (SOPs). Provide expertise in production analysis, problem solving, and root cause analysis.Ensures schedules, project status, and safety plans are provided as. Show less

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  Thermofisher Pharma Services, Viral Vectors

  Feb 2022 - Oct 2022

  Manager OPL– Upstream Manufacturing- Current Pharma Services, Viral Vectors

  Responsible for the Upstream manufacturing of viral vectors and assumed responsibility for the formulation group. At VVS use virus-mediated transfection, also known as transduction, which offers a means to reach hard-to-transfect cell types for protein overexpression or knockdown, and it is the most commonly used method in clinical research (Glover et al., 2005; Pfeifer and Verma, 2001). I was responsible for the cell culture process through purification and the formulation of buffer and media to support operations. I assumed responsibility for Operation safety, including SCAPA. I assumed responsibility for deviation through Trackwise. Show less

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  Thermofisher VVS

  Oct 2022 - Apr 2023

  Operations Training Manager

  I have been employed by Thermofisher as a Manufacturing Manager responsible for the Formulations team, the Upstream Viral Vector Manufacturing Team, and recently been promoted to the Operations Training Manager for the Lexington site.

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  Bristol Myers Squibb

  Apr 2023 - now

  Sr. Manager Operations

  Responsible for onboarding new employees into the SUF organization. This includes a five week initial door to floor program, implementing phase II of an enhanced program, establishing a culture of learning and development, and compliance to training.