Kevin L. Smith

**** ***** ***** *****

Bloomington IN, 47401

805-***-****

adh6c9@r.postjobfree.com

Summary of Qualifications:

Business Management

Has over 27 years of experience in the Pharmaceutical/Biotech industry

Great ability in people management.

Well versed on aseptic practices, GDPs and GMPs.

Extensive process knowledge, especially Cell Culture, Purification, Formulation/Finish operations.

Computer experience. Proficient in Microsoft Word, Excel, Wonder Ware and SCADA process control systems, JD Edwards, Power Point, RT Reports, ISOtrain, BLM and PI server systems.

Good communication skills. Chaired daily meeting with direct reports covering training, process updates, procedure revisions, and group feedback sessions. Chaired daily QIT meetings with Management and support groups.

Lean Green Belt Certified

6S Certified

Regulatory/Client Audit Support

Professional Experience:

Center Manager, CSL Plasma, Bloomington, IN

September 2018- Present

Overall authority of center operations production goals.

Manage all inventories to optimum levels by maximizing efficiencies, customer service levels and minimizing investment.

Monitor donor retention and ensure efficient donor flow.

Responsible for overall center quality/compliance

Responsible for all aspects of financial oversight including setting annual budget, ensuring center meets monthly financial targets, financial reporting and cash management objectives.

Ensure compliance with all company SOPs and applicable federal, state and local regulations.

Develop and foster a center philosophy of continuous improvement and support company values.

Participate during internal and regulator audits

Maintain 5s and safety standards

Conduct recruitment, training, development, counseling and termination of center staff.

Formulation and Preparation Supervisor, Baxter Healthcare, Bloomington, IN

August 2013- April 2018

Provided guidance, support, direction and leadership through positive interactions with all personnel during daily operations.

Responsible for supervising the daily production (Formulation, Preparation, Filling, and Capping Processes), scheduling, material management, staffing, compliance training and auditing activities.

Interview, hire coach, motivate, develop and discipline staff. Conduct annual performance reviews on all direct reports and assist in setting performance objectives.

Cell Culture and Purification Supervisor, Baxter BioScience, Thousand Oaks, CA

May 2007- August 2013

Provide guidance, support, direction and leadership through positive interactions with all personnel during daily operations.

Responsible for supervising the daily production (Cell Culture and Purification), scheduling, material management, staffing, compliance, training and auditing activities.

Interview, hire coach, motivate, develop and discipline staff. Conduct annual performance reviews on all direct reports and assist in setting performance objectives.

Oversee manufacturing operations such as spinner passaging/scale up, bioreactor CIP and SIP, Inoculations/cell harvesting, media additions, chromatography filtration, and buffer and media preparation.

Production Services Supervisor, Baxter BioScience, Thousand Oaks, CA

April 2005- May 2007

Direct and ensure all production areas, including critical process zones such as filling lines are sanitized and critical operations are monitored. Implement and maintain compliance with current good manufacturing practices (cGMP), environmental health and safety (EHS) guidelines, and FDA regulations.

Maintain department support exceptions and requirements, document review, employee time management, development plans, and employee review processing, employee training, budget control, and daily scheduling.

Cell Culture Manufacturing Associate III, Baxter BioScience, Thousand Oaks, CA

June 2000 – April 2005

Expert in working on and troubleshooting several manufacturing systems, such as bioreactors harvest vessels, harvest carts, media carts, and CIP skids.

Aseptic practices under laminar flow hoods (LFA) during spinner passage and sample aliquot.

Responsible for leading floor operations by adhering to current good manufacturing procedures (cGMP), training new hires on Cell Culture operations, and ensuring that production schedule requirements are met.

Method M/ CPM Manufacturing Technician Lead, Baxter BioScience, Los Angeles, CA

May 1996 –June 2000

Responsibilities included processing Anti-Hemophilic Factor M (AHF-M), supervising floor operations, assigning daily activities, assisting and training manufacturing personnel.

Operating and troubleshooting Clean in Place (CIP), Steam in Place (SIP) systems.

Skilled on buffer preparation, filter integrity testing, and autoclave operations.

Chromatography column packing, operations, troubleshooting.

Performed bulk dilutions and sterile filtrations.

Fractionation Manufacturing Technician, Baxter BioScience, Los Angeles, CA

January 1991- May 1996

Responsibilities included buffer preparation, centrifuge operations, filter press operations, and performed depth filtrations.

Performed laboratory procedures, such as product titrations, protein assay, and measuring product pH with calibrated pH meter.

Education

BS Business Management, University of Phoenix 2012

Associates in Business Administration, Axia College of University of Phoenix 2010

High School Diploma, June 1988, Port Huron Northern, Port Huron, MI

Contact this candidate