Contact

adbtta@r.postjobfree.com

www.linkedin.com/in/derwin-k-

moore-673802b (LinkedIn)

Top Skills

GMP

CAPA

Validation

Certifications

Six Sigma Green Belt (CSSGB)

Derwin K Moore

Manager, Clinical Manufacturing

Greater New York City Area

Summary

Extensive record of success directing production and operations in pharmaceutical, medical device and electronics manufacturing environments. Special expertise in enhancing compliance with cGMP, safety, OSHA, DEA, and other regulations while lowering costs and improving processes. Excel at value stream management, scrap reduction, root cause analysis, and technology deployment. Experienced at managing the design, validation, and startup of manufacturing and packaging lines. Adept at building and leading top performing teams, minimizing employee turnover, and streamlining work processes. Administered budgets as large as $14M and supervised up to 125 persons in union and non-union environments. Previously directed plants with annual revenues of $200M and 375,000 sq. ft. of operational space. Background encompasses non- classified through Class 100 environments. Familiar with Six Sigma, DMAIC, and Kaizen methodologies. Certified Project Management Professional.

Experience

Particle Sciences, A Lubrizol Life Science Company Clinical Manufacturing Manager

July 2019 - Present

Bethlehem, Pa

• Manage daily operations in Clinical Manufacturing, including providing supervision for production personnel engaged in manufacture of drug products.

• Determine staffing requirements and oversee the interview, hiring and training of new employees.

• Ensure all staff receives appropriate training on job duties, corporate policies, applicable regulations and Quality Management Systems.

• Provide coaching and mentoring and conduct evaluations of all subordinate managers within the department.

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• Ensure all manufacturing areas are appropriate for intended use and maintained in a state of readiness, in compliance with US and EU requirements.

• Review, approve and author Master Batch Records (MBR’s), Standard Operating procedures, Qualification/Validation protocols and reports, calibration reports, and other essential cGMP documents, as necessary.

• Ensure appropriate supervision is assigned and maintained for oversight of all activities.

• Ensure timely, accurate production planning, including sourcing and purchasing; coordinate repair and maintenance work within assigned areas.

• Establish and implement departmental goals, objectives and procedures.

• Monitor departmental performance against goals and objectives.

• Maintain awareness of inventory for consumable and packaging goods used in manufacturing. Develop and manage vendor relationships as needed. Provide oversight of ordering, organization and stocking in clinical manufacturing.

• Implement a continuous improvement environment, focusing on a right-first- time approach.

• Foster a “safety first” culture; understand, implement and enforce the safety program.

• Manage efficient use of company materials.

• Direct interactions with clients and regulatory agencies.

• Ensure efficient management of quality and cost control.

• Organize meetings; maintain a sustainable relationship with cross-functional team members.

Merck

Manager, Operations

April 2017 - April 2019 (2 years 1 month)

Merck & Co., Inc. West Point, PA

Merck & Co., Inc. West Point, Pennsylvania 19846 2017 - 2019 Manager, Operations

Coordinate and supervise the daily activities of individual contributors, set priorities for the team to ensure task completion and meeting daily deadlines; coordinates work activities with other supervisors. Identifies and resolves standard day to day quality, technical, and operational problems within unit

• Utilize sound judgement and decision making to ensure quality product is reliably produced while managing cost.

• Responsible for performance metrics (Schedule Adherence, Release on Time, Customer service performance, Product Lead Time, etc.). Page 2 of 5

• Accountable for developing a Production System and continuous improvement culture while achieving targets and business results.

• Identify, prioritize and champion improvement initiatives to improve process efficiency, cycle time, and yield, reduce process variability.

• Accountable for meeting business acumen and understanding the business impact to finances.

• People Management – Responsible for creating and sustaining a highly engaged workforce through utilization of Core leadership Behaviors and Inclusion.

• Provide coaching on professional development and career paths. Provide timely feedback and performance evaluations for direct reports after obtaining the relevant input and evaluation.

• Direct, coordinate; provide guidance and counseling to group leaders to assure optimum quality and quantity of finished products. BAE Systems, Inc.

Value Stream Specialist Principle

2015 - 2017 (2 years)

Greenlawn, NY

• Supported production, business, and other processes in a team-based manufacturing environment.

• Performed activities in a variety of cross-functional areas including production planning, Rough Cut Capacity Planning (RCCP) and control, total quality management, systems, manufacturing, equipment and facilities engineering, material management, and process re-engineering.

• Led a production team of 4 focus factories spanning 3 shift comprising of 55 employees (Contract, Exempt and non-exempt).

• Interact with internal and external customers with respect to product planning, problem resolution, and process improvement.

• Tracked and reported on SQDC (Safety, Quality, Delivery, Cost) metrics weekly.

• Contract review and signatory.

NBTY USA (Contract)

Department Manager

April 2014 - August 2015 (1 year 5 months)

Bohemia, NY

• Manage daily activities for production of vitamin and dietary supplements

(Pharmacy, Blends, Granulation, Compression and Encapsulation). Page 3 of 5

• Warehouse Management (SAP and Oracle), Inventory Control and Cycle Counts.

• Contract review and signatory.

Norwich Pharmaceutical

Operations Value Stream Line Manager

August 2013 - February 2014 (7 months)

Norwich, NY ( 6 months Contract)

Oversaw daily safety, quality, and training compliance for production and packaging areas of a 375,000 sq. ft. manufacturing facility. Monitored and reviewed master and production batch records, batches completed per month, on-time delivery vs. customer orders, equipment downtime, deviation, work-in-progress (WIP), quality, throughput, and output. Carried out tracking and analysis of out of tolerance/out of specification (OOT/ OOS), trends, Corrective and Preventive Actions (CAPAs), and deviations. Supervised staff of 52. Monitored performance and provided coaching and feedback.

Directed high speed packaging lines encompassing bottle and blister packaging technology.

Selected Accomplishments:

• Key member of team that installed and validated two major packaging/ fill lines (Blister packing and Solid Dose bottle fill) that enabled greater productivity while lowering operating costs by requiring fewer personnel.

• DEA - Schedule II, III, IV, and V control substance authorization. LifeCell Corporation

Production Manager

June 2007 - June 2012 (5 years 1 month)

• Directed the manufacturing of medical devices for a global surgical and medical device manufacturer's Animal (Porcine) Tissue Processing department.

• Supervised staff of 55, including supervisors, process engineers, and production specialists in non-classified through Class 100 environments.

• Led the production and packaging of multiple SKUs and 30,000 units per year. Monitored production and expenses.

Bayer HealthCare

Production Superintendent

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May 1985 - April 2006 (21 years)

• Promoted to oversee production and finances for a startup 80,000 sq. ft. multi-story manufacturing suite. Supervised staff of 20. Directed manufacturing and facility qualification. Performed vendor selection.

• Purchased and qualified $14M in production equipment, including CIP and SIP systems, lyophilizors, packaging systems, and aseptic processing equipment. Developed all protocols and procedures.

• Conducted batch record reviews of CAPAs, cGMP, QA audits, and training. Education

University of New Haven

Business Administration and Management, General

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