Deep Patel, Ph.D. Email & Phone Number

San Diego, Ca, Us

San Diego, Ca, Us

San Diego, Ca, Us

San Diego, Ca, Us

Highly experienced and results-driven professional with a strong background in leading the successful implementation of mRNA/Replicon Lipid Nanoparticles (LNPs) Drug Product therapies for clinical and commercial cGMP manufacturing. Providing strategic guidance and support throughout the entire process, from Tech Transfer and Process Development/Optimization to Quality-by-Design and Validation, and GMP Manufacturing phases.• Perform various scale-up and global technology transfer (Europe, USA, Asia), project tasks/activities such as evaluating process scale and manufacturability, evaluating facility fit and equipment capability, and determining manufacturing process control strategy to internal and external cGMP manufacturing operations.• Demonstrated technical leadership and subject matter expertise in areas such as buffer formulation, sterile filtration, TFF, Fill/Finish, Lyophilization, and Packaging. Proven ability to provide floor support, lead investigations, drive change control, optimize processes, troubleshoot technical issues, and implement manufacturing process improvements.• Successfully led stage-appropriate technology transfer teams and associated projects to support New Product Introduction, Process Performance Qualification (commercialization), and Product Lifecycle Management. Strong project management skills coupled with a keen focus on delivering results within timelines and budgetary constraints.• Valuable contributions to process FMEA, gap assessments, and the development of control strategy documents. Expertise in supporting regulatory filings by guiding the drafting, reviewing, and approval of CMC sections for global submissions. Skilled in handling health authority questions, agency interactions, and product-related inspections.• Proficient in authoring and reviewing critical documents including batch records, tech transfer reports, bill of materials, process descriptions, project reports, engineering specifications, and summary reports.

San Diego, California, Us

Designed and executed experiments and worked actively at the bench and manage all CMC activities and successfully developed formulation and process using new technologies for stabilization of fusion proteins (lipid–polymer hybrid nanoparticles) using immunotherapy (adjuvants, checkpoint inhibitors, mAbs) drug development programs for Cancer treatment. Utilizing and applying experience from fields of biomedical engineering, biomaterials (polymers and composites), nanoparticles fabrication and its characterization with a focus on drug delivery. • Investigating new and progressive manufacturing technologies for biopharmaceuticals to prepare synthetic nanoparticles, biological nanoparticles, and hybrid nanoparticles (combines the advantages of liposomes & polymeric nanoparticles into a single nanocarrier as conjugates).• Design and conduct formulation and processing research to develop robust and functional cell membrane based biological nanoparticle drug products utilizing Quality by Design (QbD) and risk assessment concepts for biopharmaceuticals products for Sub-cutaneous & Intra-tumoral drug delivery.• Technical project representative and key member of CMC team, responsible for communicating strategic discussion to project teams, Carry out R&D activities and CMC activities for biopharm product development throughout early and late phase for formulation and process development and facilitate optimize process scale up and manufacturing activities and its optimizations to provide quality materials for nonclinical and clinical trials.• Interfaced with R&D and Manufacturing to ensure cross-functional alignment on technology prioritization in clinical and commercial manufacturing settings to CMOs and oversaw the design, construction, and capital equipment procurement for laboratories.

East Rutherford, New Jersey, Us

Provide expert formulation services and responsible in executing and coordinating to CMC teams for small molecule (IND,NDA, 505(b)(2) and ANDA) projects to the pharmaceutical industry, for solid dosage forms and liquid dosage forms, including product and process technology transfers, new product launches, scale up, validations, revalidations, hold time studies, root cause analyses, and continuous process improvement activities, QbD and non-clinical & clinical supplies.• Expertise in complex formulation development using wide variety of conventional and non-conventional technologies including amorphous formulations, nanoparticles, controlled release, and fixed dose combinations.• Perform cross functional coordination (in-house and with clients) with Research and Development, Regulatory Affairs, Production, Quality Assurance, Quality Control, Engineering, PPIC or any relevant departments to accomplish assigned functional tasks.

East Rutherford, New Jersey, Us

• Provide formulation services for small molecule projects to the pharmaceutical industry, including solid dosage forms (tablets, capsules, mini-tablets, powders, and granules) and liquid dosage forms (suspensions and solutions) using various pharmaceutical technologies. • Designed and conducted formulation trials using scientific breakthroughs supporting the optimization of novel therapeutic agents including branded, generic, and 505(b)(2) solutions.• Identify root cause of issues for effective troubleshooting and implement proper control strategies. Coordinate testing and validation with internal teams, facilitated client meetings, and wrote client reports.• Write Batch records/protocols and all other manufacturing documents (Product development reports and others).• Trusted advisor to clients for ideas and expertise on alternate development approaches and in making process changes. Also provide scale-up and tech transfer activities support for the commercial manufacturing process.• Developed and executed manufacturing processes, made prototype batches, scale-up development work and its registration and prepared technical documents for client IND, NDA, 505(b)(2) and ANDA submissions.

Brentford, Middlesex, Gb

• Conducted highly innovative research that applied successfully to make solid formulations for large molecules (proteins/peptides/mABS), setting the stage for future business opportunities.• Contributed to a team culture of innovation and high performance by developing a proof of concept and formulating solid dispersion for in-house large molecules using spray drying technique using bench top spray dryer (GLP) and scaling up to pilot scale (cGMP); developed processes to test and analyze molecular compounds for characterization, stability, selection and scaling.• Created and executed design of experiments, formulation development, process development, process optimization, and scale-up process for biopharmaceutical studies.• Developed a model to predict solubility and stability for other high-potential molecules based on protein structure, stability, solubility and aggregate data.

Basel, Baselstadt, Ch

• Performed R&TD activities supporting exploratory vaccine development projects (FLU vaccine and other exploratory vaccines).• Analyzed primary packaging components to determine optimal solution that addressed all requirements for safety and storage for all the vaccine formulations.• Performed glass delamination studies and characterizing the elemental analysis using ICP-OES along with Container Closure Integrity Test to evaluate the stability indicating parameter of the different containers/closures (vials/stoppers/caps).

Doctor Of Philosophy (Ph.D.), Pharmaceutical Sciences

Master Of Science (Ms), Pharmaceutical Sciences

Bachelor Of Pharmacy (Bpharm), Pharmaceutical Sciences