Marty Damask Email & Phone Number

Durham, North Carolina, US

Lead Global compliance of Quality Systems in a Contract Manufacturing Organization (CMO) setting, which focuses on mammalian cell culture protein therapeutics / microbial fermentation, and cell therapy. Monitors and evaluates the effectiveness of corporate / global compliance programs and implements change, as required, to ensure compliance to cGMP.

Durham, North Carolina, US

• Provide Deviation/CAPA support for the biopharmaceutical manufacturing process owners/groups.

Basel, Baselstadt, CH

• Execute the Avexis Global Program for exception management, certification and recertification of lead investigators and approvers.
• Perform high level (Critical and Speak-up/DI) investigations as requested by QA Leadership.
• Support audit and inspections of key IE related topics, for both internal and agency inspections at the global and site level. Collaborate on responses to any regulatory findings as they relate to key investigations.
• Support the IE team through NCR/CAPA processing/Advising in support all DI and Speak-up related issues across the Avexis Network.
• Perform Regulatory document reviews as needed in support of additional filings for Zolgensma.

The Manager Manufacturing Support – Deviation/CAPA Management is responsible to support theprimary manufacturing process owners and the manufacturing groups by providing required support tothe engineering, validation, MSAT, maintenance, QC and QA groups at both the Durham and Libertyvillemanufacturing sites. The Manager Manufacturing Support –.

Somerset, NJ, US

Responsible for managing, developing and leading 10 auditors to perform auditing of all revenue-generating documents to include Lab Analysis reports, Protocols and Certificates of Analysis.Provide Quality oversight and support of deviation investigations and CAPAs for a contract research organization which includes contract manufacturing.

Somerset, NJ, US

Responsible for the production of inhaled products (MDI, pMDI, DPI and nasal), sterile injectable mixtures and other formulations for Clinical Trials.This includes maintenance, setup, operation, changeover, and routine maintenance of automated and manual production equipment. Responsible for conducting investigations into manufacturing deviations and.

Lake Forest, IL, US

• Manufacturing Manager for 3-shift, Small and Large Volume Parenteral Terminal Sterilization and Packaging of solutions and emulsions (sterile injectable / aseptic).
• Manage, develop and train a multi-functional staff under FDA regulations for medical device and pharmaceutical products.
• Integral part of deviation investigations and CAPA development and execution.
• Maximize productivity, equipment utilization and overall efficiency through planning, team management and change management.
• 97% production rate 2015 - over 50% decrease in Personnel-caused deviations since taking over department. - 83% decrease in overall deviations since taking over department.
• Provide fiscal responsibility through management of overtime, preventive maintenance programs, and direct budget oversight.

Lake Forest, IL, US

Supervisor of a night shift for SVP Sterilization and Packaging of solutions and emulsions (sterile injectables). Scope of responsibility includes ensuring that all standard operating procedures are followed to meet current good manufacturing practices (cGMP). Maintain records asrequired, monitor and verify quality in accordance with FDA.

Corning, New York, US

Manufacturing Operations SupervisorCorning Life Sciences/Becton-Dickinson, Durham, NC Manage, train, and develop a non-exempt night-shift force of 25 associates in an FDA and cGMP environment. Foster and lead Continuous Improvements and Lean Initiatives through Visual Management, 5-S, and Kaizen events. Maximize productivity, equipment utilization and.

• Dual-Hatted as the functional Operations Director and Human Resources Director.
• Provided leadership in developing and executing human resources strategy in support of the overall business plan.
• Executed the planning, organizing, supervising and coordinating of management and administrative systems related to the operations, logistics management, and facilities management of a growing dental laboratory

Nijmegen, NL

Responsible for development and management of Packaging Operations to support US Supply Chain to include: Responsibility for budgeting and fiscal management; Program development, execution, maintenance and evaluation; Scheduling, planning and resource management. Responsible for packaging of stability, clinical and other Investigational Medicinal Products.

Nijmegen, NL

Responsible for successful proejct management: start-up GMP solid-dose packaging facility to include creation of User Requirement Specifications for the facility, construction project management support, facility layout design, packaging equipment line design and procurement. Responsible for creating department infrastructure and budget for US Packaging.

• Achieved 100%+ Production to schedule for multiple years by setting challenging production goals, engaging the operators to become stakeholders in the business, and listening and acting on operators’ recommendations.
• Identified, organized and then executed project management tasks for the manufacturing and packaging portion of a product line change that saved approximately $1 million annually by reducing component and labor costs.

• Start-up operation: Manage, train and develop a non-exempt force of 52 associates in an ISO 9002 environment.
• Coached, challenged and motivated operators of a startup photonics manufacturing operation that resulted in three recognition awards for Leadership, Training and shift performance.

Boston, Massachusetts, US

Responsible for daily operations (distribution, receiving and storage of documents and media) in the Rochester, NY market. Responsible for employee health, welfare and training.

Manage, train, and develop a non-exempt force of up to 50 associates in environments to include FDA and DEA regulated, and GMP. Responsible for leading Solid- and Liquid-dose manufacturing operations.Received recognition awards for Leadership, Training and shift performance.

Manage, train, and develop a non-exempt force of up to 52 associates in environments to include ISO 9002, FDA and DEA regulated, and GMP. Responsible for medical device manufacturing.Received recognition awards for Leadership, Training and shift performance.Recognized for establishing root cause analysis methodology.

Arlington, Virginia, US

• Responsible for program development and performance assessment. Responsible for scheduling of training and management of resources for a variety of organizations. Consistently built diverse staffs to support mission.
• Successfully managed a cost-effective annual budget of over 1 million German Marks.
• Developed multiple programs and organizations to satisfy military and community activity requirements in international locations.
• Formally recognized for outstanding achievement during Operation Desert Storm in Iraq.
• Consistently built diverse staffs to support mission, vision and goals in multiple assignments.
• Former enlisted from 1983 to 1985. Nuclear Biological Chemical Non-Commissioned Officer role for a combat armored battalion.

Master Of Science (M.S.), Organizational Management

B.S., Political Science (Minor: International Relations)

Political Science