Manager Manufacturing

Paul T. Falencki

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

Lakewood NJ ***01

848-***-**** ************@***.***

SUMMARY

Results-driven and versatile manager with over 25 years of increasing responsibility in the pharmaceutical industry. Extensive production experience including in-depth knowledge of cGMP’s, FDA, OSHA, and DEA regulations within a manufacturing environment. Demonstrated strong planning, organizational, and decisive leadership skills. Performance and process oriented with a commitment to quality and continuous improvement.

PROFESSIONAL EXPERIENCE

WEST-WARD PHARMACEUTICALS, Eatontown, NJ 7/2012 – 1/2017

Packaging Manager 9/2016-1/2017

Develop and execute optimization strategies for the Packaging processes in alignment with Site objectives (i.e. increased reliability, reductions in cost, cycle-time and non-conformances). Specific responsibility to ensure that the packaging plan has been executed in a timely manner in accordance with Quality Standards and the Serialization Program Initiative for continuous improvement is executed.

Warehouse Manager/Continuous Improvement Manager 6/2013- 9/2016

Accountable for the Warehouse Distribution Operation, Pharmacy(Weighing) Department and Material Handling in the Eatontown Facility. Specific responsibility to streamline the movement of materials between five (5) buildings on a daily basis ensuring quality and on time reliable customer service.

Manages receipts, storage and distribution of materials in compliance with established procedures, practices. Government regulations and standard operating procedures.

Provide Logistical support for facility upgrades, site material and equipment flow, new product launches and transfers.

Revised shipping and receiving procedures to include tracking of incoming and outbound shipments, damages and collaboration with the Purchasing Department to start Vendor Education program

Continuously improve material movement activities to provide rapid, on-time delivery of products and services to internal and external customers in an efficient, least costly and effective way.

Perform and monitor system data for receipts and cycle times.

Assisted in the re-design of the Pharmacy Department ensuring a clean, safe and orderly work flow environment.

Develop and prepare a budget to meet Cost reductions, Vendor and Carrier selections, Contract Services, Leasing Agreements and Process Improvements.

Formalized work procedures by authoring and revising procedures, CAPAs and Investigations.

Establish the Batch Manufacturing Module initiative designed to remove complexity and improve reliability.

Assisted in leading problem-solving efforts to ensure Batch Right the First Time (BRFT) program exceeded 90%.

Developed and Tracked Improvement Projects for Warehouse, Pharmacy, Operations, Packaging and R&D areas.

Sr. Manufacturing Manager 7/2012-6/2013

Develop and execute optimization strategies for the manufacturing processes in alignment with Site objectives (i.e. increased reliability, reductions in cost, cycle-time and non-conformances). Specific responsibility for continuous improvement in the Manufacturing Operation and Warehouse Management yielding tangible results. Effectively managing multiple priorities for different departments ensuring short and long term goals are met.

Collaborated with the Validation Department in the cleaning validation of manufacturing equipment and processes.

Assisted in the re-design of the manufacturing process for Methocarbamol and Doxycycline Tablets resulting in work flow improvements, reduction in downtime, reduction in labor hours and increased output.

Formalized work procedures by revising SOPs (Standard Operating Procedures) to include Cleaning Checklists and Set-up Checklists for each equipment. This process gives continuity and empowerment to the operator to execute their task.

Charged with the installation of the “Mettler-Toledo Weigh System” which is an automatic weighing system to prevent under or over weighing of specific drug products.

Paul T. Falencki Page Two

CORE PHARMACEUTICALS, Middlesex, NJ 8/2010 – 6/2012

Sr. Manufacturing Manager 8/2010-6/2011

Managed and directed multiple Manufacturing Departments including Dispensing, Blending, Encapsulation, Dosage, and Coating across 3 shifts. Ensured that the production plan has been executed in a timely manner in accordance with Quality Standards. Analyzed and resolved work issues with Product and personnel. Implemented training systems across the department to meet technical needs.

Corroborated with the Planning and Inventory Control Dept. (PPIC) on meeting the monthly output schedule. Increased output by 80% from 11 batches/month to 21 batches /month.

Reduced CAPA (Corrective Action/Preventative Action) resolutions by 30% by improving work flow procedures along with team and department daily meetings.

Initiated, hired and developed training of supervisory staff within production to meet requirements across 3 shifts.

Created Departmental Goals resulting in cycle time reduction and NCE (Non-Conforming Events). Set up baseline reporting for shift output and Batch Right First Time (BRFT) to reduce errors and increase throughput.

Sr. Packaging Manager 6/2011-6/2012

Managed the Packaging operations across 3 packaging lines on 2 shifts. Supervised, hired and directed a work force to build and maintain efficient and effective work teams compliant with cGMP packaging requirements and processes. Ensured that the packaging plan has been executed in a timely manner in accordance with Quality Standards. Implemented and developed a training system across the department to meet technical needs.

Initiated and revised over 20 SOPs (Standard Operating Procedures) to ensure packaging compliance.

Reduced the packaging backlog by 80% from 82 to 20 batches in one month through workflow improvements and team meetings stressing an improved culture change.

Corroborated with the Cleaning Validation Department ensuring that cleaning procedures are revised and followed. Implemented quality control checks to ensure that packaging meets environment, health, and safety regulations.

Created Departmental Goals resulting in cycle time reduction and NCE (Non-Conforming Events).

NORWICH PHARMACEUTICALS, Norwich, NY 2/2010 – 6/2010

Value Stream Manager

Managed and directed multiple Manufacturing Departments including Dispensing, Blending, Encapsulation, Banding, Packaging, Warehousing, Distribution and Receiving across 3 shifts working within a union environment. Ensured that the production plan has been executed in a timely manner to meet schedule adherence. Implemented training across the value streams to meet technical requirements.

Organized a Safety Leadership Team (SLT) charged with developing Safety Programs with the focus on reducing lost time accidents. Resulted in a 30% reduction YTD.

Successfully launched a new product (Zegerid OTC) on time by improving work flow procedures.

Initiated training of salaried employees within the production streams with labor relations on the new labor contract. Training completed for 30% of personnel to date.

Participated in the development of Departmental Goals resulting in cycletime reduction by 30%. Quality Varience Reports (QVR) reduced by 25%. Set up baseline reporting for Batch Right First Time (BRFT) to reduce errors and increase throughput. Maintain Schedule Adherence at 95%.

Reached the goal of 99% on time performance YTD by changing the process flow of shipping requirements.

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WATSON PHARMACEUTICALS (formerly Schein Pharmaceuticals) 1990 – 2009

Production / Planning / Inventory Control Manager, Carmel, NY 2005 – 2009

Oversaw the planning, purchasing, and warehousing activities ensuring each department maintained a planned volume to 95% capacity with a Finished Goods release schedule meeting 95% capacity, and maintained a Finished Goods level of 8 weeks of supply. Worked closely with all manufacturing managers in developing capacity, needs analysis and tracking of production outputs (volumes).

Created planned volume increases from 1.2 billion units to 4.5 billion units by ensuring department processes were streamlined and actual outputs were tracked and measured against the plan.

Implemented and tracked Supplier Schedules and Supplier Education Days to ensure On-Time Delivery Performance to be 95% or better.

Led companywide Planning and Process Improvement Program that involved training 200 salaried and hourly employees by using the Oliver Wight MRP II class “A” enabling program. Received Class “A” Accreditation in the Planning and Process Control Module.

Audited Bills of Materials, Item Masters and Work Centers for accuracy reducing the number of batch record errors by 35%.

Trained and cross trained all department employees on SOP, TOP, cGMP, and DOP policies.

Developed a successful plan for each department which resulted in work-in-process (WIP) reduction of 20% and an increase of Finished Goods weeks of supply (WOS) to 8weeks.

Assisted in providing input for establishing annual budgets for all departments.

WATSON PHARMACEUTICALS (Continued)

Plant Manufacturing Manager, Danbury, CT 2001 – 2005

Managed high volume plant with 50 production and 4 supervisory personnel. Managed and directed multiple Manufacturing Departments including Compounding, Dosage, Coating, Printing, Warehousing, Shipping & Receiving. Implemented training, coaching, and disciplinary actions as needed, and ensured manufacturing schedule was met and headcount was maintained to support production.

Streamlined overall production process through tracking measurements that ensured standards were met increasing production 30%.

Created safe and healthy work environment by conducting monthly meetings to focus on safety and housekeeping resulting in zero (0) lost time accidents over 3 years.

Maintained employee productivity and commitment to quality with weekly scheduled meetings with Quality Assurance to discuss non-conforming events.

Implemented cross-training program for all employees to remain current in SOP, DEA, OSHA and cGMP related issues.

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WATSON PHARMACEUTICALS (Continued)

Manufacturing Manager, Carmel, NY 1995 – 2001

Managed Encapsulation Department for two years until position expanded to include Dosage, and Coating departments totaling a staff size of 27. Assisted Director of Manufacturing with department structure, developing budgets, and long-range planning to meet or exceed production levels. Reviewed procedures on an ongoing basis seeking ways to improve the efficiency of manufacturing operations while preserving a safe working environment.

Streamlined overall production operations through tracking measurements resulting in a reduction of cycle time by 27% and an increase in output by 60%.

Implemented Behavior Based Safety Program (BBS) which focused employee attention on safety and lost time accidents.

Established measurable department goals based on production, safety and cost reduction.

Packaging Supervisor, Carmel, NY 1990 – 1995

Assumed responsibility for five packaging lines of solid dosing manufacturing. Provided training and ensured protocols were followed for SOP, DOP, OSHA, and cGMP. Provided coaching and disciplinary guidance. Verified scheduling and payroll hours and assisted in completion of deviations.

Initiated training program to cross train 60 direct employees on all packaging operations.

Assisted in the automation of the packaging lines which resulted in workforce reduction and an increase in capacity output by 50%.

EDUCATION, CERTIFICATION AND TRAINING

Associates Degree in Business Administration, Somerset County Community College, Branchburg, NJ

Certified Hazmat Site Commander

Class “A” accreditation in O.W. MRPII Planning and Process Control

Ongoing Professional Development through various Pharmaceutical seminars

Team member involved in the implementation of J.D. Edwards (JDE) Enterprise System

Steven Covey’s course, “7 Habits of Highly Effective People”

Team member involved in the implementation of Serialization Program Initiative for Packaging.

Ongoing Professional Development for Yellow and Green Belt Training

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