Khaled Yamout Email & Phone Number

Rockville, Maryland, Us

USP Expert Panel “Best Practices for mRNA Vaccines”, Committee Chair

Provide strategic and thought leadership in establishing and leading scientific and operational teams and processes, analytical laboratories and contributing to the overall company vision and CMC strategy.

San Diego, California, Us

San Diego, California, Us

San Diego, Ca, Us

Tampa, Florida, Us

Pacira Pharmaceuticals, San Diego, CA. 2015-current Senior MANAGER, QC Raw MaterialsManage and provide leadership to the raw material, reference standards program, lab support function, and life cycle and PM management of instrumentation under GMP guidelines. Duties include routine testing and test methods validation/transfer in-house and at contract laboratories, qualification of raw materials, resolve supplier change notifications, resolve CAPA’s, and conduct GMP audits of contract labs and suppliers.

Santa Clara, Ca, Us

Managed Production Chemistry, Quality Control, technical customer quality complaints and special product requests under GMP and ISO 9001 guidelines.•Championed continuous product improvement projects that resulted in stabilizing product lines, reduced scrap by 70% and improved cost of goods. •Improved workflow, inventory and production down time by consolidating functions, resources and talents. •Reduced production cost for a fast growing product line by over $1.5 M/year.•Subject Matter Expert in Quality, procurement, Manufacturing, R&D, and marketing to resolve technical and process issues related to products and customers.

Remotely managed and directed the discovery, development, formulation, QC testing and manufacturing of API and drug product for the treatment of dyslipidemia. This includes negotiating contracts and proposals. • Discovered and developed API and drug product to meet the requirement for preclinical, Phase I and Phase II clinical trials.• Negotiated contracts and proposals that met business needs.• Transferred developed methods and procedures to various sites and companies for use in product manufacturing, clinical and toxicological studies.• Identified long term synthesis of the API that is robust and cost effective for commercial launch (Metric ton scale).• Acquired, prepared and maintained data for CMC documents.• Directed research and testing of a library of candidates for the treatment of dyslipidemia and the syntheses of possible and known metabolites of Diazoxide.• Generated the required IP for the API and formulation, resulting in multiple patents (US7572789, US7799777, EP1968601, EP2404604, and WO/2007/081521).

Established a functional lab to develop reagents for use in Point of Care immunoassays.• Developed a highly efficient capture system on plastic surface that out-performed known commercial products (US2006/011322, WO/2006/105110).

San Diego, Ca, Us

Established, managed, designed, budgeted, staffed, developed and trained personnel, and equipped a Reagent Department responsible for organic synthesis, recombinant protein production, protein purification, and antibody production and screening.• Developed and transferred synthetic drug derivatives, protein conjugates, recombinant proteins and antibodies to manufacturing department (China); transfer included procedures, QC methods and specifications to be followed under GMP guidelines.

Established, managed and staffed Process Development, product transfer and Manufacturing Departments to produce DNA and protein microarrays reagents. • Devised a method to quantify the amount of protein on the surface of colloidal gold particles.• Discovered of a novel method for synthesizing star shaped gold particles. • Developed a novel method for the synthesis, derivatization and purification of colloidal silver particles.

Us

Established, staffed and managed daily operation of a Production Chemistry Department operating under strict GMP guidelines.• Transferred and developed the processes for multiple products from R&D to manufacturing.• Reduced scrap and cost of reagents by optimizing synthetic and protein conjugation processes.

• Synthesized novel stereo specific amphetamine and methamphetamine derivatives (US 7,037,669, EP1733230, WO/2005/093417) and novel LSD derivatives for developing a non-radioactive homogenous immunoassay.

Advanced Organic Chemistry

Bachelor'S Degree, Chemistry With Minor In Physics And Mathematics