Patrick Griffith Email & Phone Number

Denver, Colorado, Us

Lead the evaluation and optimization of products and processes to achieve company goals.Bridge R&D, Quality, Production, Engineering, and Supply Chain to ensure cohesive objectives.Provide technical expertise from R&D to production regarding product and manufacturing processes.Oversee the qualification of raw materials, equipment, and processes for commercial production.Manage commercial processes, documentation, and implement process and facility improvements.Ensure facility compliance with industry standards and lead technical investigations for root cause analysis.Serve as a key member of the site leadership team influencing product, process, and business strategy decisions.

Denver, Colorado, Us

Administered technical oversight to improve formulation, filling, and manufacturing processes.Liaised between Quality and Production to integrate new or improved processes, equipment, and regulatory requirements.Led HVAC system improvements and facility validation efforts.Developed proprietary formulations and conducted large-scale technical investigations.Designed and developed batch records and SOPs to enhance manufacturing processes.

Englewood, Colorado, Us

Designed and implemented new processes into commercial production, increasing efficiency.Led a team that consistently met aggressive timelines for this start-up facility.Developed over 40 new products and managed the tech transfer of products between sites.Implemented operator training programs and procured necessary equipment for commercial production.Provided continuous support to Quality Team, conducting investigations, writing deviations, and generating technical documents.

Englewood, Colorado, Us

Provided project support for the Leiters startup, developing dynamic approaches to operational hurdles.Guided qualification of automated Labeling System and supported new Compounding Suite buildout.Drafted design specifications and validation plans, and developed a disposable self-contained isolator module.Supported equipment and facility validation through protocol execution and documentation.

Ludwigshafen, De

Led cleaning validation, process validation, and equipment qualification for cGMP operations at the BASF Surfactants Site.Developed and executed validation protocols while maintaining compliance with regulations.Reviewed data packs, drafted deviations, and generated final reports.Revised the Validation Master Plan and published Project Plans reflecting project decisions.

Ludwigshafen, De

Generated method validation protocols for API and NF-grade products.Developed and evaluated instrument reports, laboratory plans, and method validation reports.Authored over 40 validation protocols and corresponding reports, ensuring compliance with industry criteria.Coordinated lab activities supporting Cleaning Validation and provided validation support for Project Solitaire.

Las Vegas, Nv, Us

Managed the QC analytical laboratory and developed analytical test methods.Created, reviewed, and updated SOPs for compliance with 21 CFR Part 11.Trained and supervised chemists and managed lab inventory and orders.Led the reviewing process for product literature and managed third-party lab testing services.

Las Vegas, Nv, Us

Analyzed chemical composition of raw materials and finished products.Specialized in trace metal analysis and method development using ICP-MS and other techniques.Developed and optimized material analysis techniques and ensured lab compliance with cGMP standards.Played a significant role in the initial development of the lab, its procedures, and its operations.

Bethlehem, Pa, Us

Conducted routine chemical analysis to support the release of in-process, pre-sterile, and finished product samples.Utilized analytical techniques and tracked laboratory data using LIMS.Led and verified production, integrated operations with production procedures, and worked independently on the graveyard shift.