Manager Manufacturing

Norman H. Briggs

**** ***** **** ***, ***** Mount, North Carolina 27804

Home Phone: 252-***-****, Cellular Phone: 252-***-****

Email: **********@*****.***

Key Accomplishments

Experience in leading all areas of manufacturing to include: Pharmacy, Granulation, Compression, Coating, Encapsulation and Packaging

Successfully completed numerous product transfers, validations and ANDA filings.

Certified Internal Auditor. Led manufacturing department through multiple audits to include audits for Novartis and FDA preparation.

Regional Manager of the Year – 1193, 1194, & 1995

Maintenance Professional of the Year – 1991

Retired – U.S. Air Force – 1999

Professional Work Experience

Manufacturing Manager, Teva Pharmaceuticals, Lynchburg VA (Aug 2015 – present)

Responsible for managing all solid dose operations for the site (cleaning, set-up, clearing, processing and documentation of manufacturing equipment and paperwork practices with a high focus on safety and quality).

Supervise 6 direct reports and 105 hourly employees in the Pharmacy, Granulation, Compression, Coating and Encapsulation Departments

Led and implemented 5S initiative throughout manufacturing organizing area and equipment storage. Developed daily 5S Audit Checklist and initiated Site Leadership Team Weekly GEMBA walks though out manufacturing.

Worked closely with Validation, R&D and Quality and successfully delivered two product launches in 2017 ahead of schedule

When the site was in danger of losing soon to expire API, developed and led team to manufacture product before API expired (7 days) and successfully produced 11 batches of product (2 more than requested) within 4 days, saving the site over $1,000,000.

Sandoz – Division of Novartis producing generic pharmaceuticals for a global market of 130 countries, Wilson NC

Senior Manufacturing Manager, Associate Director, Manufacturing – Compression, Coating and Encapsulation and Operational Excellence (Sep 11 – April 2015)

Responsible for managing all operations (cleaning, set-up, clearing, processing and documentation of manufacturing equipment and paperwork practices with a high focus on safety and quality).

Currently managing over 80 employees across a 24/7 operational schedule.

Implemented Manufacturing Execution System throughout manufacturing and packaging

Lean Six Sigma Green Belt. Led Double-Sided Tablet Press Changeover Project, Reducing changeover time by 17.5 hours to 14.5 hours

Developed and implemented tracking systems for Downtime, Change-overs, Cleaning, and throughput.

Initiated Right-the-First (RFT) Time Initiative that included real time record review and accountability. RFT increased from 37 percent to 91 percent for department.

Reduced overtime expenditures by 40%, while improving work-life balance by implementing 12-hour shift schedule with operator involvement and buy-in.

Recognized as a proven leader and recommended by Vice-President to assume responsibility for areas struggling to achieve goals and objectives. Strong leadership skills and proven track record of developing people.

Unit Operations Facilitator (Manufacturing Manager)/Project Manager ( Sep 08- Sep 11)

Selected to manage Tech Transfer of Metformin 1000mg that had been delayed numerous times. Brought process back on track enabling Regulatory Affairs to complete FDA filing documentation 2 weeks ahead of schedule.

Took over a department that had numerous violations during FDA audit and 16 months later had no FDA findings during re-inspection while being recognized for process, cGMP and operator improvement.

Implemented Statistical Process Control (SPS) for Compression and Encapsulation. Reduced Batch Record Error Rate by 30% through the elimination of paper batch data forms for collection of Hardness, Thickness and Weight checks for in-process testing. Ensured all operators received timely training to ensure a smooth transition to new process.

Implemented Fette Training Program for all compression personnel. Three individuals were qualified as Fette Trainers through Fette North America, eliminating the need for Fette North America to conduct training at 8K per class. In a 12 month time frame 47 additional personnel were certified in Fette Basic and Advanced Operator Training.

Increased weekly compression output by 21%, while eliminating 12 hour shifts, 7 days a week and reducing operation scheduled to three 8 hour shifts, five days per week.

Packaging Supervisor (Apr 06 – Sep 08)

Developed and implemented Production Standards by bottle count and strength for each product line. Increased monthly batches packaged by 50 per month within a two month period and sustained this growth for 12 consecutive months.

Key member of Departmental Process Improvement Committee. Sited 22 opportunities for improvement, implementing 6 immediately. Eliminated redundancy in paperwork, increased Batch Record Right-the-First Time Rate by 37% in 3 weeks, further identified 12 opportunities for implementation over 12 month period. Bundler Upgrade Project eliminated packaging trays and reduced head count by 10 personnel. Annual savings was 570K with a ROI of 5 months.

Designed and implemented departmental training program for all employees. Utilized Master Training Plan and cross-functionally trained all department employees. Increased efficiency and employee morale by developing employees for future growth.

Utilized set-up sheets to set minimum line speeds by product line. Set specific targets, thereby increasing throughput and reducing departmental overtime by 50%. Set new production record during May 2007 for number of batches packaged and bottles produced per man hour expended.

Hand selected to work with Project Team to incorporate SAP into site. Also, worked with capacity planning consultants to identify areas to increase production and incorporate new methods and programs into SAP

Production Supervisor, Hospira, Rocky Mount, NC (Aug 04 – Apr 06)

Reduced lot change times by 12 percent by utilizing back-up operators to clean equipment and assist with line cleaning.

Directed the daily manufacturing operations for 7 Terminal Sterile Filling lines and supervised 59 employees in the manufacture of Small Volume Parenterals.

Assumed primary responsibility for TS Filling Line 198 and improved efficiency to 98.7% for 2005. Initiated and completed manufacturing investigations and deviations as required. Reduced Deviations/Investigations by 63% on Line 198 by assessing problem area and identifying a corrective action for bottle count variance.

Responsible for completing employee performance evaluations, monitoring payroll and recommending promotions.

Associate Manager, Manufacturing, AaiPharma (Sep 03 – Apr 04)

Managed 20 employees in the manufacture and packaging of solid dose pharmaceuticals, to include granulation, blending and milling, tableting, coating and both manual and auto-encapsulation.

Implemented training and tracking program for supervisors and employees that emphasized deficiencies and accountability that reduced Batch Record error rate for manufacturing by 47%.

Responsible for the installation and validation of new Sejong Tablet Press. Developed and implemented all associated SOPS.

Coordinated the decontamination and analysis of equipment, directed the collection and submission of samples to the lab. Implemented monitoring system to ensure equipment was always available reducing manufacturing turn time between lots.

Production Supervisor, Del Labs, Rocky Point, NC (Sep 01 – Sep 03)

Production Supervisor for New Sally Hansen Division. Directing the daily manufacturing of nine lines that produced all the Sally Hansen Nail Care Products and guiding a staff of 57 personnel.

Responsible for ensuring that manufacturing lines were ready and personnel trained during the transfer of manufacturing capacity from New York. During transition division always met customer demand and there were no out-of-stock inventory items.

Developed in-depth training and mentoring program that improved department morale, provided career path training and groomed 3 hourly employees into first line manufacturing supervisors.

Reviewed and adjusted production schedule to ensure adequate stock levels, prepare and monitor daily efficiency reports, maintain records and ensure GMP guidelines are followed.

Education

Completed 12 semester hours of courses in Master of Business Administration with Webster University.

Bachelor of Arts - Organizational Management - Colorado Christian University - 1995- Academic Achievement Award, 3.81 GPA

Associates of Arts - Liberal Arts - St. Leo College - 1994

Associate of Arts - Jet Engine Technology - Community College of the Air Force – 1993

References

References Provide Upon Request

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