Christopher Ames Email & Phone Number

Leading the Quality function at IDRx as we develop IDRX-42 for GIST and our quality systems

Responsible for the Quality Assurance oversight of GMP activities for EQRx. Also providing oversight to Quality Systems.

Lake Forest, Il, Us

Site Quality Head. Provided leadership to all Quality activities on site. Departments included chemistry lab, microbiology lab, validation, training, Quality Assurance, Quality Systems, and remediation team

Cambridge, Ma, Us

Provided leadership for the quality assurance oversight of the drug substance and drug product manufacturing at contract manufacturers for clinical and commercial products.

Experienced Pharmaceutical Professional with a demonstrated history of working in the pharmaceutical and biotechnology industry for innovator, generic, and contract manufacturing companies. Held corporate and site management roles in validation and equipment qualification and site and department leadership roles in quality. Excellent oral and written communication, organizational, interpersonal, and collaborative skills. Experienced in most parenteral and solid drug product dosage forms and active pharmaceutical ingredients. Highly skilled in all aspects of validation: process, cleaning, sterilization, aseptic process, analytical method, and facility, equipment, and utility qualification.

Gaithersburg, Maryland, Us

Site Sold by Sanofi Pasteur to Emergent Biosolutions.Site Quality Head. Provide strategic direction, guidance, and leadership to the Quality Organization at the Canton site ensuring the quality and compliance systems meet company policies and regulatory agency expectations. Accountable for the site quality department including the chemical and microbiological testing, compliance, documentation, batch record review and release, training, and stability of commercial products. Provided oversight of establishment and monitoring metrics, supplier quality program, validation, computer systems, and quality systems while fostering continuous improvement and inspection readiness. Provided review and approval of Standard Operating Procedures (SOPs), batch records, specifications, and change control documentation. Supervised staff of 4 direct reports and an extended team of 40, which includes regular feedback, performance appraisals, and career development.

Paris, France, Fr

Site Quality Head. Provide strategic direction, guidance, and leadership to the Quality Organization at the Canton site ensuring the quality and compliance systems meet company policies and regulatory agency expectations. Accountable for the site quality department including the chemical and microbiological testing, compliance, documentation, batch record review and release, training, and stability of commercial products. Provided oversight of establishment and monitoring metrics, supplier quality program, validation, computer systems, and quality systems while fostering continuous improvement and inspection readiness. Provided review and approval of Standard Operating Procedures (SOPs), batch records, specifications, and change control documentation. Supervised staff of 4 direct reports and an extended team of 40, which includes regular feedback, performance appraisals, and career development.

Paris, France, Fr

Provided strategic direction, guidance, coaching, leadership and communication between sites in the harmonization and improvement of the commissioning and qualification practices at all six (6) US and European sites. Provided site support where needed. Led the internal global Validation Community of Practice for sharing best practices and review of global qualification and validation documents. Participated in the design review and establishment of qualification approaches for major capital projects.

Paris, France, Fr

Developed and provided leadership, strategic direction, and resource scheduling to the quality assurance group who provided QA oversight to all aspects of validation including process, cleaning, sterilization, analytical method, computer system, and equipment commissioning and qualification (manufacturing and laboratory) in the Allston facility. Recruited and supervised staff of six (6) direct reports, which included regular feedback, performance evaluations, and career development and management of 4-15 contractors. Prioritize reviews to manage multiple projects. Managed and led the QA oversight and defense during the third-party review of Consent Decree Validation activities covering facility, equipment and utility qualifications following renovation of the QC laboratories, biologics purification facility, and development laboratories, validation of steam sterilization and cleaning, validation of revised methods, revalidation of the manufacturing process, and creation of procedures for validation (process, cleaning, sterilization), qualification, and test method validation. Reviewed and approved Standard Operating Procedures (SOPs), batch records, specifications, and change control documentation. Qualified trainer for site validation procedures.

Lake Forest, Il, Us

Responsible for the Validation program within Hospira at the corporate level as well as the site level. Provided coaching, guidance and direction to the corporation for process, cleaning, and sterilization validation and equipment qualification. Acted as Subject Matter Expert for validation. Provided strategic direction, guidance, and leadership in the identification and implementation of best practices, harmonization and improvement of the validation programs at all the twelve (12) global sites in the US and Europe. Provided on-site support for validation efforts when required. Managed 12 site Validation Managers at global locations and an additional three (3) direct reports at the corporate level Subject Matter Experts.

Somerset, Nj, Us

Led the implementation of qualification and all validation aspects of the global quality system at all the Catalent global sites in the US, Europe, Australia, Asia, and South America. Provided oversight and functioned as a technical resource or Subject Matter Expert for validation. Authored and lead finalization of corporate policies and standards for process validation, cleaning validation, and facility, equipment, and utility qualification. Established metrics to measure right the first time, on-time projects, and deviations to monitor compliance, effectiveness, and efficiency of validation programs. Led the identification and implementation of best practices in validation. Provided on-site support, coaching, mentoring and guidance to the site validation organizations on process validation, packaging validation, cleaning validation, equipment qualification, process automation, sterilization validation, aseptic process simulations, and computer system validation programs.

Switzerland 🇨🇭 , Ch

Direct the validation program at the Roche sites in Nutley and Totowa, NJ. Responsibilities included:• Process validation, packaging validation, cleaning validation, equipment qualification including process automation, and computer system validation programs for the on-going manufacturing of solids, liquids and sterile antibiotics. • Authored the site Validation Master Plan and provided oversight or approval of the Sub Plans. • Implemented a stream lined approach to equipment qualification and process validation. • Provided support for process and product investigations. An integral management team member of the site implementation of a lean six sigma program and have received basic Six Sigma training and Project Champion’s training. • Primary contact for Validation issues during regulatory authority (e.g. FDA, EMEA) audits. • Provided input and review of the Roche global validation guidances.

Rahway, New Jersey, Us

Career at Schering began as a validation engineer and rose through various positions of increasing responsibility in quality and validation to Site, Quality Head, Director of Validation and Director of Validation Support. In the last role, I supported the validation efforts at three sites under the Schering Consent Decree.