Manager Manufacturing

SCOTT K. STARBUCK

** ***** ***** ***** *’Fallon, MO 63366 513-***-**** ************@*****.***

SUMMARY

Management Professional with extensive manufacturing experience in regulated cGMP environments. Diverse responsibilities for multi-shift plants and overall operations. Successful track record for cost reductions, quality improvements, volume increases and budget management. Proficient with 5S, Statistical Process Control, Root Cause Analysis, Total Productive Manufacturing, and Lean Initiatives.

PROFESSIONAL EXPERIENCE

Nesher Pharmaceuticals Bridgeton, Mo 2016 to 03/2018

Operations Manager-

Responsible for the operations of granulating/blending of powders, compression and coating of controlled OSD products for a 24/5 operation.

Reduced downtime by 50 % by extending campaign length of products at both sites.

Reduced waste of products manufactured.

Decoupled the coating process reduce time to prep and coat tablets

Established separate processing areas to allow all three to be manufactured at the same time.

Developed Daily Operations Meetings at both sites.

Alkem Labs Inc. Fenton, Mo 2016

Associate Director, Manufacturing

Oversees management of all areas of manufacturing to produce products and direct activities so that approved products are manufactured on schedule and within quality standards and cost objectives.

Increased efficiency of nasal spray line from four lots per month to seven lots.

Reduced deviations to no more than one in every three lots produced from multiple deviations per lot.

Reduced batch record errors.

Morton Grove Pharmaceutical Morton Grove, IL 2013 –2016

Manufacturer of Generic oral liquid, topical and oral solid dose pharmaceuticals.

Senior Manager of Production

Directs the departments processing operations along with teaming with R&D and Technical Services departments to optimize new products and processes to the department.

Production Manager- Oral Solid Dose

Manage final construction, installation, commissioning and validation of department and equipment for the Oral Solid Dose Department.

Directed the purchasing of all ancillary equipment

Lead the establishment of SOP’s

Assisted engineering with the final construction, installation and purchasing of major equipment.

Coordinated with QA and Validation in completion of validation of all equipment.

Manufacturing member in technical product transfers to site and third party contractors

Coordinated new products from R/D department, from pilot to submission batches.

VIJON LABORATORIES St Louis, MO 2012-2013

Health and Beauty Aids Manufacturer and Packager

Production Supervisor

Responsible for the direct supervision of line leaders for the operational and personnel decisions related to scheduling production lines, as well as the quality of the finished product.

Direct and coordinate, through subordinate line leader personnel, the activities of the label storage, label control, and both preventative and restorative maintenance on all production and facility equipment.

Supervise staff to ensure company safety procedures, policies and administrative procedures are implemented.

JLM Pharmatech Seymour, IN 2011-2012

Nutraceutical and pharmaceutical contract manufacturing and packaging.

Site Manager.

Develops and directs overall Site Master Plan capital strategies, provide leadership to Strategic

Projects team for developing the tactical plans for implementation, and monitor/advise on the

execution of these activities.

Provides direction in developing, tracking, reporting and reacting to appropriate metrics for

measuring and improving success of strategies implemented.

Provides leadership for the strategic projects team that ensures colleague engagement in a

change environment.

Work closely with senior leadership to understand the site direction and respond accordingly to

develop a Site Master Plan and annual Capital Plan to support it.

Manufacture PIC 46 % fine powder, 60,000 Kg’s annually to be distributed, bulk, also to be Encapsulated, tableted and manufactured into Beads.

Mallinckrodt – Covidien Maryland Heights, MO 2006-2011

Radio-pharmaceutical Manufacturer (Aseptic filling, Sterile, Injectables)

Superintendent Cyclotron Hot Products (CHP), Reactor Hot Products (RHP), Sterile Core Operations

Report to Production Manager

Collaborate with the Continuous Improvement group leadership team members to ensure the

mission, objectives, and strategies are executed consistently and to the fullest extent to support.

Assess colleague and contractor resources needed to execute on the Site Master Plan projects

and adjust resourcing level accordingly to optimize resources available and successful

achievement of the plan.

Stay closely connected to our client’s global capital management strategies making

recommendations for work stream implementations that align themselves with these global

strategies.

Managed 6 Production Supervisors representing 3 shifts of 4 departments and a total staff of 65 personnel.

Assist in the engineering development and transfer of new products.

Production contact for Construction projects including installation of Cyclotron

Responsible for all second shift production to coordinate department communications. Departments included, QA, QC, Maintenance, Radiation Physics, Shipping along with 3 production areas.

Responsible for Plant Sanitization Department.

P3 Laboratories, LLC. Winder, GA 2005-2006

Generic and proprietary developer and manufacturer of pharmaceutical products.

Director of Manufacturing

Report to the President. Responsible for diverse operations: blending powders and liquids, compression, mixing, filling and packaging.

Automated Filling and Packaging department in less than six months.

Developed area productions plans and measured team performance.

Coordinated with R&D for the transfer of process to Manufacturing.

Teva Laboratories Cincinnati, OH 2003-2005

Generic and proprietary pharmaceutical manufacturer (Formerly Barr Laboratories).

MANUFACTURING SUPERVISOR

Report to Production Manager. Responsible for Granulation, Blending, Compression, Coating, Encapsulation and Replacement Therapy departments.

Developed area production plans and measured team performance.

Assigned resources to meet the manufacturing schedule on a day-to-day basis.

Served as a technical and training resource for the manufacturing team.

Coordinated with R&D and Technical Services to schedule equipment SOP and staff readiness.

Assisted Engineering to establish process and cleaning validation requirements for specified product.

Xactdose Inc. South Beloit, IL 1999-2003

Pharmaceutical re-packager of unit dose liquids and solids

Director of Operations

Report to the President. Responsible for all plant manufacturing operations including: labeling, maintenance, safety and security, shipping and receiving.

Reduced costs in labor refuse disposal, pest control, security and shipping.

4x volume increase of production batches.

Automation of pick and place system to eliminate manual placement stations.

Procured new filling and labeling equipment for oral syringe products, managed new product development for the line.

Responsible for employee training for both job tasks and cGHP requirements.

Reviewed and approved validation protocols for equipment, processes and new product development.

First Priority Inc. Elgin, IL

Production Manager – Blending &Packaging

Sunstar Pharmaceutical Inc. Elgin, IL

Production Manager – Blending, tableting & Packaging

Anderson Contract Packaging. Rockford, IL

Production Manager

EDUCATION

B.S. Business Administration

Rockford University Rockford, IL

A.S. Chemistry

Rock Valley College Rockford, IL

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