Mark Feild Email & Phone Number

Specializing in biopharmaceutical and gene therapy products, providing guidance, interpretation, and recommendations for the development of quality control, stability, and in-process testing methods, regulatory CMC sections, stability studies, and product or impurity characterization. Draft SOPs and protocols for laboratory cGMP quality systems.

• Responsible for developing, implementing and maintaining the quality systems and tools required to manage and monitor the quality and compliance aspects of pharmaceuticals, excipients, and combination drug-device.
• Developed and deployed an initial quality system strategy to ensure that products conform to defined requirements for 21 CFR Parts 210/211 (e.g. Quality manual, management review, non-conformances, investigations.
• Oversaw Standard Operating Procedures, work instructions, forms, templates and other documents associated with the Quality Systems
• Managed interactions with customers concerning the quality of products, systems, and processes
• Reviewed and wrote as needed, qualification and validation protocols/reports for test methods, equipment qualification and process validation, as well as other technical reports.

San Diego, CA, US

• This position reports to the Quality/Regulatory Unit. A hands-on director of a cGMP Analytical Laboratory facility for a contract manufacturer of pharmaceutical and biopharmaceutical products. Ensured that the.
• Lead the coordination of projects with Quality Assurance, Quality Control, Manufacturing, Product Development, and Process Development.
• Oversaw Analytical Laboratory facility client and regulatory audits. Ensured compliance and success.
• Developed, transferred and Validated GMP methods for the Quality Control facility.
• Performed cGMP reference standard qualification, product characterization, and stability studies.
• Provided technical leadership and support to clients during product development, CMC-pertinent sections of INDs and license applications.

• Co-founder of WindRose Analytica, a contract analytical development and testing laboratory specializing in protein and biotechnology-product characterization and analytics. Instituted strategic and innovative.
• Defined the corporate standards and procedures for phase-appropriate development of the analytical programs.
• Ensured lab facilities met and maintained compliance with client and current regulatory requirements.
• Hired, trained, and directed laboratory activities of seven laboratory professionals.
• Conducted laboratory experiments for client projects; analytical method transfer, method development, method qualification, method validation, product and reference standard characterization, and stability studies.
• Developed the company Quality Systems.

Thousand Oaks, CA, US

• Managed group responsible for defining corporate philosophies and requirements in-process, equipment, cleaning, transportation, analytical method and computer validation.
• Developed validation requirements and translate them into standards and quality systems.
• Chaired the Validation All Site Team (VAST), responsible for developing unified strategies for validation, managing implementation timelines, and resolving validation issues.
• Provided leadership for the maintenance of the validation quality systems across sites to ensure quality oversight and continuous improvement.
• Supervised management-level personal and manage quality improvement projects.
• Participated in technology transfer process improvements.

Thousand Oaks, CA, US

• Identified, developed and qualified assays required for product release and characterization of anti-obesity drug candidates. Characterize reference standards and isolate impurities/degradants in products and stability.
• Led the department efforts for the anti-obesity drug candidate programs. Quality Satellite Team (QST) Leader.
• Additional product responsibilities included AMG-162 (Prolia), IL-1ra (Kineret), IL-1ra analogs, sTNF r1, and Epogen.
• Supervised two Research Associates and two Research Scientists.
• Developed and authored analytical methods, technical reports, CMC sections for INDs, NDAs and other regulatory documents.
• Resolved assay-specific and quality issues concerning validation of cleaning processes for Amgen and contract fill/finish facilities.

Thousand Oaks, CA, US

Team Leader for Leptin and Kepivance programs. Department representative for Leptin Operational Development Team, New Product Introduction Team, and Clinical-Research-Process Team.