Jugdeep Singh Email & Phone Number

New York, Ny, Us

New York, New York

Accounting, tax preparation, bookkeeping, pay rolling, developing client relations, marketing, website development, Negotiating IRS/ NYS/ Labor department issues, Business development, Human Resourcing, etc.

Greater New York City Area

Established and built a multilocation Tax Preparation, Accounting, Payroll Services, and Audit Issue disputing company that serves client not just in the greater New York City area, but on a global scale.

Ensure all Manufacturing Quality aspect of various Gene Therapy, Cell Therapy, and Stem Cell Products that the Gene Transfer group is responsible for. In addition, establish a Quality Control Group where we can do all in house quality testing for the product and Environmental Monitoring samples tested.QC Testing (Coulter Counting, Southern Blot, PCR, EM, Mycoplasma, gel electrophoresis, restriction enzyme digest, etc)Environmental monitoringDocument review (SOPs, Batch Records, etc)Document Management for all (Manufacturing, QC, QA)Inventory and Facility ManagementQA line Clearance for manufacturingEquipment PreparationEquipment Alarm Management Managing Facility upgradesVendor ManagementInvoice ManagementProcess Design and layoutMaster Batch Record Update and Write upEquipment and Process Validation (IQ/OQ/PQ) Documentation Review and ApprovalManagement Equipment Parameters and Trend cyclesManagement Process Parameters and Trend cyclesWrite up and close out OOS reports for processes

Improve and develop new methods (upstream and downstream) to establish a scalable commercial process for a new biologic under FDA, EMEA, and ICH guideline. Manage Multiple Projects with tight and strict deadlines Create Gnat charts and timelines for projects and ensure timelines are met by all departments and parties involved.Tech Transfer of biopharmaceutical production information, materials, and know-how to various CMOs; and California)Review, revise, and write SOPs, Master Batch Records (Technical Writing)Test new techniques, methodologies, and experiment for scale upWork closely with Quality Assurance to improve the overall quality of department and drug development processAnalyze and quantify equipment and process dataDocument Management for both process development and manufacturing.Write up and close out OOS reports with CAPA.Improve current methodologiesPurchasing and ordering equipment and materials.Vendor Management (Ordering, negotiating, sourcing, etc).Managing Invoices and Purchase Orders Manage the department's BudgetManage the Project scope with CMOs Manage Project Scopes for outside vendorsOrganize materials and content for US PatentWrite up and execute Validation protocols for GMP equipmentsTrain staff on new technologies and methodologiesAssist in development of Quality Systems.Quality Auditing of CMOs

Coordinate daily activities in the department and other departments.Train other colleagues on various equipment and Protocols (took lead on training associates on all three shifts on Far West equipment with Delta V and HMI)Ultrafiltration, Chromatography, and CIP/SIPs.Work alongside with Validation and automation with various projects (two New Ultrafiltration installation, Annual equipment validations, UF clean time studies, filter upgrades, Day tanks installation, Buffer Tanks installation, Chromatography upgrades, UF upgrades, etc.). Calibration and usage of Lab equipment (i.e. pH meter, conductivity meter, OD 280, osmolarity, etc.)Troubleshoot problems with equipment as they arise on a daily basis. Lead Role on the Non-Conformance Training Team: Help devise an auditing function internally to observe coworkers and how they carry out certain tasks. Develop presentations to avoid any reoccurring NCs. Develop methods to avoid any type of NC.Clean In Place (CIP), Steam in Place (SIP), and Clean out of Place (COP) of various equipment in the facility.Part of The GMP Task force- to ensure GMP compliance are meet by auditing work area, ensuring people are following proper procedures, etc. Part of the Mistake Proofing Team: A team that investigates the process overall to pinpoint and probable mistakes and come up with potential solution to avoid any pitfalls. Mistake proof the UF, help revise SOPs for the new UF procedure and any upcoming changes. Member on the 5S team to improves the workflow in the work area. Part of the Credo Action team for two years. Class taken at Centocor University: Stepping up to Manager, ABCs of PE, Ethical Decision-Making, Standards of Leadership, Biotech for beginners. Etc.Achievements:Received over 13 Encore/Star Awards for working on various projects, teams, going beyond the call of duty to help my colleagues, strategic planning, teamwork, etc.

Purification of humanized antibodies, via column chromatography (Q1, Q2, S-Sephrose and protein A), usage tangential flow systems (Centrasettes, Centramates, and Maximates) to concentrate the product and difiltration, and product filling into vials.Assisted in changing a protocol to produce a larger amount of monoclonal antibodyOrder the proper equipment, and worked closely with the Quality Department to everything was in accordance to regulations.Coordinate daily activities and assigned them to coworkers. Assist in the Development of Phase II Clinical Research and Program.Column PackingCalibration and usage of Lab equipment (i.e. pH meter, conductivity meter, OD 280, osmolarity, etc.)Document Control Development of large-scale buffers for the each process (Tris/HCL, NaOH, Glycine, PBS, etc.).Equipment calibration for most steps is required (i.e. flow rates, pH Meter, conductivity meter, spectrometer, etc.) and equipment set up (Column Chromatography, Tangential flow systems, product filling devices, etc.).SOP and Master Batch Record write up for processes used by the company.Batch record review. Understanding of proper documentation procedure and document control.Ordering all the components and equipment for each process done to make products (from containers to pumps to column chromatography)Getting the equipment validated and calibrated before using the equipment in production.

Bs, Biology With Bioengineering

Certificate, Sas Base Programing

Certificate, Project Management

Graduate Certificate, Bioscience Industry