Michael Bray Email & Phone Number

• Support audit programs, including Moc PAIs, and GMP audits of the manufacturing, filling, packaging processes, and functional systems, and develops solutions to mitigate identified gaps.• Quality and scientific review of documents such as EBRs, validations, specifications, methods and method transfer, stability data and reports, OOS/OOT investigations, and complaints.• Oversees the manufacturing and packaging activities and execution of the quality systems to support the manufacturing, testing, packaging, and labeling of finished products.• Performs audits/reviews of manufacturing and packaging batch records ensuring data integrity, processes align with regulations, client’s SOPs, and cGMPs.• Generate, revise, and review SOPs, policies, forms, and templates and approve investigations and CAPAs.

Denver, Colorado, United States

- Primarily responsible for directing and managing the operations of a cGxP consulting company and acting as the main point of client communications.- Act as key contact for cGMP audits.- Coordinate and conduct GMP/Moc PAI audits to ensure they are timely, thorough, and meet the appropriate standards.- Work with client companies to build a QMS and remediate gaps in operations to ensure cGMP compliance, including writing policies, SOPs, forms, or other required documents.

Fort Collins, Colorado Area

- Integrated with company leadership in building a R&D Stage Gate Process to ensure cross-functional alignment on key decisions/priorities, consistency in product development, transparency in decision making and accountability for targets, efficiency and balance.- Establish, maintain and provide oversight of QbD templates and process for R&D.- Created and maintained R&D Core Team checklist for the Specialty Injectables, Topicals and Proprietary programs.- Establish and maintain the Lab Excellence Program that builds a structured performance management process including the definition of suitable metrics and daily review huddles to ensure optimal lab support for product development.- Created resource planning & scheduling tool to evaluate capacity and demand.- Review and approve equipment, product and method protocols and validations.

Fort Collins, Colorado Area

- Responsible for the Analytical Development, analytical method development, process review and development including regulatory change control, investigation review, and execution of Analytical Development support initiatives in the areas of analytical (HPLC) method transfer improvement, optimization, and troubleshooting. - Interface with Quality departments to improve documentation requirements for accurate communication of method validation, transfer and instruction for raw materials, intermediates, and finished products.- Monitor and review ICH, USP, EP and other applicable compendial/regulatory updates to ensure that updates to monographs, general chapters and guidelines are tracked and implemented. - Define plans and timelines for implementation of updates, evaluate and enhance optimization and improvements to ensure compliance and attain greater efficiency in AD processes.-Ensure that all AD operations and functions are in full FDA, cGMP, OSHA and DEA regulatory compliance.-Develop and implement training programs in AD and ensure that employees are properly trained.- Responsible to meet objectives while managing spending, capital and labor to budget.- Communicate openly to provide and gather information to optimize the use of resources and efficiency.- Evaluates AD capacity and suggests best practices to facilitate product launch success.

- Manage quality, compliance and service expectations as well as monitor the on-going quality/compliance performance of suppliers.- Responsible for driving / initiating External Supplier Quality Risk assessments for all External Suppliers and identify gaps in Quality Systems with sound remediation plans.- Interface with Supply Chain Management to ensure supplier statuses are maintained and made visible, supporting business needs while maintaining compliance for suppliers.- Lead periodic Supplier Quality Review Board meetings.- Direct Contact with distributors/manufacturers for prompt issue resolution.- Perform and/or conduct for cause audits.- Engage with SQM colleagues at all North American sites to identify/implement best practices.

Broomfield, Co/East Hanover, Nj

- Define and implement Quality Agreements with third parties to include QbD elements.- Performing new project QA Due Diligence project reviews and supplier quality evaluations.- Review of third party investigations, change controls & compliance issues working directly with the Supply Chain and Development departments to assure rapid & appropriate response to quality related matters for third parties.

Broomfield Co

- Provide Quality Assurance oversight for Quality Control/Analytical Development Laboratories. - Provide QA review and approval of new and existing SOPs, analytical methods & specifications, investigation documentation, and process control documents as well as lead internal audits. - Lead teams using trend and investigational data to create value through process improvements and failure reduction activities.

Broomfield, Colorado

- Managed the technology transfer of analytical methods to and from the manufacturing site in Broomfield.- Manage analytical staff of 5, day-to-day lab operations for the method transfer laboratory.- Develop and manage project plans for ANDA projects and their technology transfer.-Using the Project Life Cycle approach, collect technical requirements and compile them into PM Tools (e.g., GANTT charts and Critical Path Method - PERT) to coordinate cross-functional teams for internal and external project technology transfers.- Manage and interface with functional based laboratory operation to a Project Team based Development Organization and assisted in external audits. - Prepare, review, and approve project reports and technical documents for CMC/ANDA registration with FDA.- Maintain cGMPs, Standard Operating Procedures, Lab Safety (including MSDSs), maintenance and trouble shooting.

Broomfield, Colorado

- Manage analytical staff of 20, day-to-day lab operations and technical projects of a cGMP In-Vitro drug development and testing laboratory. - Develop and manage project plans for ANDA projects and their technology transfer.-Using the Project Life Cycle approach, collect technical requirements and compile them into PM Tools (e.g., GANTT charts and Critical Path Method - PERT) to coordinate cross-functional teams for internal and external project technology transfers.- Manage and interface with functional based laboratory operation to a Project Team based Development Organization and assisted in external audits. - Prepare, review, and approve project reports and technical documents for CMC/ANDA registration with FDA.- Maintain cGMPs, Standard Operating Procedures, Lab Safety (including MSDSs), maintenance and trouble shooting.

- Establish, manage and direct the operations of a newly formed business unit – a cGMP In-Vitro drug testing lab for contract revenue in this Contract Research Organization (CRO). - Plan and develop departmental organization including setup of the laboratory and its equipment, reviewed/approved laboratory data, reports and SOPs, and recruiting/ training staff. - Responsible for business development, sales development while managing the operational budget of ~$1MM. - Negotiation of contracts and management of client contacts to assess and develop stability/ analytical testing, methods development, and validation programs for a variety of product types.

- Responsible for the overall laboratory function including supervision, training, and performance reviews of 14 degreed chemist.- Administer daily laboratory workload, released raw materials for manufacturing, and analytical data for both finished products and R&D samples (Clinical and Stability).

- Responsible for assisting in fundamental biochemical cancer research. - Prepared biological samples for separation on chemically bonded molecular sieve (preparatory) columns for measurement of adduct formation via terbium enhanced phosphorescence.