Manufacturing Coordinator

• Oct 2021 - Present

Assist inventory management & Procurement team by analyzing raw materials and comparison usage requirements for future production schedules. Coordination of raw materials, in-process, finished product and investigative samples with Analytical and Quality control. Ensure personnel follow processes expressed within SOP's. Assist in the authoring, reviewing, and approvals of SOP’s, Batch Records, Logbooks, and Equipment Method development. Identify MFG risk and develop mitigation plans and rectifications for corrective actions. Communicate with external vendors for research and selection of GMP Materials and Equipment. Assist procurement team in the purchasing process of GMP Equipment, supplies, services, ect. Scheduling and coordination for Validation procedures within the GMP Area. Authoring of Equipment parameter lists, risk assessments, and method development, for GMP Processes and procedures on equipment. DOE’s for GMP processes, procedures, and methods. Coordinate with Facilities and ENG groups to align activities to meet deadlines. Identify and communicate internal/ external constraints that may impact MFG milestone. Track and analyze MFG KPI's that drive accountability and improvements in MFG metrics. Liaise with QA department to ensure all MFG quality Incidents, inv, resolved in a timely manner. Contribute to process improvement initiatives. Participating in internal/ external meetings with procurement, engineering, contractors, and construction teams to achieve KPI’s Scheduling of external department liaise with operators, technical scientist, and manager. Scheduling of work week activities and activity deadlines to ensure efficacy of company time. Assisting procurement and materials management in the coordination of shipment pick-up of GMP process samples. Authoring Electronic Lab Notebook entries of all GMP method development processes. Organization of the GMP Installation scheduling

Formulation Scientist

• Feb 2021 - Oct 2021

Designing and developing formulationprocesses for various compounds, including for oral dosage forms and sterile injectables. •Working with scientists and engineers to enable innovative approaches for formulation, fill/finish and packaging to produce FDA-approved drugs.•Participating in project management and product development strategies, including leading technical, legal, and regulatory aspects of formulation activities.•Maintaining leading edge by keeping up to date on regulatory guidelines, technical innovations, and new developments within the pharmaceutical industry.•Delivering results in a high paced environment.

Upstream/ Downstream Manufacturing Associate

• Dec 2019 - Feb 2021

Qualified Trainer in cGMP Procedures and Equipment. ● Completes Batch Production Records under cGMP, and documents in detail through the use of SOPs and BPRs for the processes and manufacturing steps● Support initiation and closure of deviations; serve as the player in the departmental investigation and responsible for closing out deviations and CAPAs.● Extensive experience with AKTA ready and AKTA pilot chromatography equipment, columns, TFF, CIP procedures and of processes to purify bulk proteins, antibodies, etc. (IEX, Affinity)● Troubleshoot process and equipment problems; Work with Facilities and Validation to maintain manufacturing equipment.● Ability to apply theories and principles utilized to solve operational, as well as routine tasks in the purification of proteins, antibodies, etc. for Phase I/II GMP manufacturing.● Work closely with production management for current and new manufacturing projects and help develop processes/techniques to meet contract objectives and avoid operational delays.● Participate in facility expansion and equipment validation activities.● Perform buffer preparations, in-process sampling, formulation of bulk drug substance.●Proficient in Delta V, Unicorn, MERP and LIMS.● Understanding and knowledge of isolating and purifying proteins from microbial and cell culture processes● Set-up, operate, maintain and clean downstream bio processing equipment.●Monitors critical process parameters including operations of chromatography skids and Tangential Flow Filtration.●Product filtration (Depth filtration, ultra filtration, viral filtration)

Fashion Model

• Aug 2012 - Jul 2020

Originally beginning as a hobby, my Modeling career has grown over the years. As my portfolio has extended I have been gifted with sponsorship deals and small contracts to model clothing and video games for a varying clientele. Originally beginning as a hobby, my Modeling career has grown over the years. As my portfolio has extended I have been gifted with sponsorship deals and small contracts to model clothing and video games for a varying clientele.

Food Server

• Aug 2015 - Dec 2019