Charles Brawley's Pharma Site

I am currently the Manufacturing Supervisor at Genzyme Biotherapeutics in the Cell Culture Purification Department.

Charles Brawley was previously the manufacturing manager at Braintree Laboratories in Braintree Massachusetts.  I was hired by Braintree Laboratories to manage several product lines and to impact remediation efforts in response to numerous 483 issues. Prior to my accepting a position at Genzyme all 483 issues had been resolved and the newest product at Braintree Laboratories met FDA approval. To meet FDA approval, I directly led a pragmatic effort to design and implement new training systems, including a new software program. The manufacturing management team reviewed and revised all standard operating procedures. I was a leader of teams that worked on warning letter remediation and collaborated with Lachman Associates representatives, the firm hired to consult and review remediation with the FDA.  

My employment history includes Charm Sciences(Enzyme Center), Alkermes (rHgh and Insulin plants), and Millennium Pharmaceuticals. In these positions I have been involved in projects and scale up efforts that produced the Pocketswab™ for HACCP, Production and purification of IgGsorb (click here), Genomic Research (click here) and genomic libraries, Human Growth Hormone(rHgH) Alkermes(click here)/ Genentech,  Human Inhaled Insulin Alkermes/ Lilly (click here), and Phoslo (renal failure).

I am a quality and safety minded pharmaceutical professional with twenty years experience. During my employment I have nurtured safety, lean management principles (5S), TQM, quality “right first time” manufacturing teams, and culture development. I have obtained a firm grasp of CFR and GMP interpretation from years of experience and application of the CGMP and FDA Guidance. I have developed a keen ability to work cross functionally.  I have been part of the EDR management (Trackwise), CAPA resolution, Training management (Isotrain, TOBE),  quality systems improvement, continuous improvement, quality by design, and safety. I have successfully managed manufacturing 483 issues, resolving the 483 issues and completing the remediation of warning letters.

I have obtained a broad range of skills working on solid dosage forms, inhalable drugs, and sterile injectable drugs. I have formulation, fermentation, purification(ANX, UF/DF, SP, Nano), spray drying, blending, filling, tableting, encapsulation, and packaging experience.

Management

I am an excellent manager of people and systems. I have a proven track record of developing goals, obtaining results, while building a culture of teamwork. I am an excellent communicator. I deliver expected results from the teams I build and manage.

Technical skills

Manufacturing equipment operation FAT, IQ/OQ/PQ. I have operated, validated, preventively maintained, and written SOP for numerous  manufacturing equipment and processes. I have a strong under standing of various software applications; TrackWise, Isotrain, Plateau, Great Plains, Oracle, Kronos, Project, Excel.

High pressure systems, piping design, HVAC (USAF) School of Civil Engineering.

Training

I have been a trainer of CGMP for three different companies and a training manager for two, including CGMP training, process training, and in some cases safety content design and delivery.

Safety

I have continuously been assigned to safety teams, committees, and been the safety manager for my last two companies developing OSHA programs for PPE, respiratory protection, crane safety, hearing protection, and confined space.