Peter J. Email & Phone Number

Haymarket, VA, US

Virginia, United States

Supporting Clients CMC, Reg Affairs, and Quality Compliance needs

Virginia, United States

• Provide G and L clients regulatory and quality support for pharmaceutical programs.
• Supported Products include antibody drug conjugates, monoclonal antibodies, gene therapy virus vectors, solid oral antipsychotics, nature derived clinically relevant biomolecules, and novel solid oral dosage forms at.
• Manage client regulatory filings on mandated timelines for scientific content and adherence to regulator guidance for application integrity.
• Gap assessments on client Type C Meeting Packages
• Facilitate resolution of client compliance needs, including quality system development, PAI readiness, cGMP batch record and validation review, supplier and internal audits, deviation and CAPAs, as well as direct.

Peter Jordan provided operational, regulatory, quality, and business supportto the healthcare products industry. He specializes in product chemistry,manufacturing, and controls (CMC) management; analytical methoddevelopment and validation; virus clearance validation; CMC regulatorysubmissions; current good manufacturing practices (cGMP) and current.

Haymarket, Virginia

• Provided Regulatory and CMC strategy support as needed for biologic products.
• Ensured Mapi/Icon delivered Quality Assurance and Regulatory Services to multiple client programs which included Positron emission tomography therapy manufacturing concerns, antibody production, gene therapy product.
• Delivered compliance risk analyses for both application & agency comment remediation.
• Oversaw client initiatives for technology transfer (process and analytical), validation management, and quality compliance program implementation. Served as “person in plant “support for clients working on resolution.

Herndon, VA

• Supported multiple client’s pharmaceutical projects CMC and quality compliance issues. Client programs ranged from recombinant proteins, biosimilar drugs, animal blood derived and tissue derived active compounds, solid.
• Managed technical projects to support changes to commercial manufacturing processes and analytical methodology. Managed CMOs/CROS for project development & commercial drug production objectives
• Provided person in plant representation for development, scale-up engineering, validation, and manufacturing activities at multiple client vendors both domestic and international facilities in support of clinical phase.
• Managed client mandated timelines for CMC project Supported logistics issues related to each client project for validated shipping, import/export, customs clearance, etc.
• Launched virus clearance support function within SciLucent.
• Drafted, technically reviewed, and executed final submission of CMC sections for Pre-IND, IND, CBE-30, NDS, MAA, NDA and BLA, and PAS filings for clients.

AS1 In charge of all viral clearance studies for Medimmune and Astrazeneca for all early and late stage mammalian cell culture products. Responsible for interfacing with CMC representatives, planning studies, sourcing materials to contract labs, and interfacing with contract lab personnel for study execution, performing GLP studies, report generation, and.

Rockville, MD

Tech Transfer, Development and manufacturing of albumin fusion proteins.Downstream Manufacturing DevelopmentDeveloped, Performed, and Optimized cGMP purification of Albumin Fusion Protein therapeutics expressed by S. cerevisiae and CHO cells at 10L to 1500L scales. Designed Experiments to model operating ranges. Drafted reports to support Manufacturing.

Process Development and ManufacturingPerformed scaled-down process characterization experiments for modeling of manufacturing operating parameters. Served as "Person in Plant" during the Manufacturing Conformance Runs. Drafted reports to support Manufacturing Process Limits and BLA filing requirements.

Bachelors Of Science, Microbiology; Biochemistry

Additionally, I took a Cooperative extension at GSK where I cut my teeth on downstream processing.

Masters Of Science, Management

Worked full time while acquiring my Master's Degree

Associates Of Applied Science, Ecology And Environmental Technologies

Water testing, macro-invertebrate identification, chemistry, biology, etc.

Masters

Associate Of Science - As, Ecology And Environmental Technologies

Masters Of Science