Experience

Bioserv Corporation

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Manufacturing Associate Director Bioserv - Sorrento Therapeutics

  • Jul 2022 - Present

  • Directly supervise Manufacturing Associates, Technicians, and associated temporary employees following cGMP and GDP practices, processes, and procedures. • Review, Modify, and Manage the Manufacturing planning and work scheduling process. Coordinate with the Project Management team to successfully execute the plan. • Responsible for producing weekly Manufacturing department work assignments. • Evaluate, modify, and update the Manufacturing department training program. Ensure that Manufacturing department personnel are trained, and work in compliance with Quality department requirements. Ensure that department personnel are trained and comply with EHS department training requirements. • Ensure that the Manufacturing team provides support to the Project Management team during job set-up and customer interface when necessary. • Review and approve periodic reports produced by the Quality department as required. Brief the manufacturing department on the report contents and findings. • Ensure any assigned failure investigations and corrective actions are completed in a timely and quality manner. • Prepare long-term and short-term goals and plans for the development of the department based on corporate goals. Show less



Nucleix Ltd.

• Israel
• Biotechnology Research
• 1 - 100 Employee

• Sr. Manufacturing Manager

  • Nov 2021 - Jul 2022

  Formulate high-quality reagents for clinical applications. Set up supply agreements with vendors and procure materials for the purpose of creating a sustainable supply chain. Establish materials specifications for incoming reagents, QCs, shelf-life, storage, etc. Supervise and perform experiments on reagents using a variety of techniques, including qPCR and spectrophotometric analysis. Manage DHF activities (product design and risk documentation) to facilitate product transfer between R&D and Manufacturing. Project management duties- communicate status updates, resourcing requirements, and plans to stakeholders, including timeline, cost, and scope analysis. Support validation efforts for new product introductions. Work with global operations and manufacturing teams to establish, optimize and unify processes when appropriate. Provide technical support and troubleshooting to other personnel. Contribute to quality initiatives to maintain an environment of continuous improvement throughout the organization. Long-term management of day-to-day activities of internal and external (CMO) Manufacturing/QC teams. Show less



Genalyte, Inc.

• United States
• Biotechnology
• 1 - 100 Employee

• Technology Development Manager

  • Mar 2017 - Dec 2021

  Under limited guidance, manage complex technical product development, operational support and technology transfer activities across multi-disciplinary boundaries including Instrument Engineering, Consumables, Chemistry, Biologics and IVD Assay Development from vendor management and raw material handling to process development and execution on technology development plans in the lab. Directly manage the day-to-day activities of the Manufacturing/Lab Tech team members. Under limited guidance, manage complex technical product development, operational support and technology transfer activities across multi-disciplinary boundaries including Instrument Engineering, Consumables, Chemistry, Biologics and IVD Assay Development from vendor management and raw material handling to process development and execution on technology development plans in the lab. Directly manage the day-to-day activities of the Manufacturing/Lab Tech team members.



Assure Controls

• Lab Manager

  • Jan 2006 - Dec 2017

  Established all laboratory procedures for a new company using live organisms for water quality testing. In this position, the challenges were to develop all requirements for equipment, supplies, reagents, environmental controls, inspection criteria, laboratory methods and Standard Operating Procedures. This includes the scientific review and support of a small laboratory based in Hong Kong. In this consulting position, there are constant requirements for new experimental designs to test and qualify the live organisms for use in customer applications. The position requires the ability to work directly with the CEO on current needs, maintain highest quality inventory, establish plans, and communicate outcomes. Show less

• Biological support-Consultant

  • Jan 2006 - Jan 2006

  Developed new protocols for use in investigations with organisms to assess water pollution. Performed acute and chronic toxicity bioassays with marine organisms to support studies and for novel alternatives being considered for use by the U.S. Navy to determine their degree of toxicity. Design experiments and provide input on new product instrumentation under development. This work resulted in a peer-reviewed scientific paper published in the Marine Pollution Bulletin (December 2007), for which included all summarizes of all toxicity test results on all substances and samples was documented. Show less



Codex DNA

• United States
• Biotechnology Research
• 1 - 100 Employee

• Reagents Supervisor

  • Feb 2014 - Mar 2017

  Working for the VP of Operations, created reagent manufacturing lab: researched/ordered equipment and materials, worked with facilities to determine lab requirements and set-up lab using 5S guidelines. Created all Standard Operating Procedures and batch records for the reagents lab. Created Bill of Materials to determine the Cost of Goods Sold for each reagent product line. Developed a system for scheduling and tracking reagent orders. Regularly communicated production goals and results to senior management, including business development, the VP of Operations and President of SGI-DNA Responsible for the transfer of new products and processes from R&D to Manufacturing. Accurately maintained records of laboratory activities in batch records. Directly trained multiple manufacturing personnel in reagent manufacturing processes. Established and performed QC test protocols for reagents produced. Performed QC testing protocols for final verification of instrument performance prior to shipment. Served as a department safety coordinator, attended quarterly safety meetings, and assisted with earthquake/fire drills. Obtained CPR certification. Performed 5S audits and reported results to senior management. Established shipping procedures for reagent products, and trained others on these new processes. Performed monthly cycle counts and managed reagent lab inventory. Reported material costs monthly to accounting. Worked closely with database engineers during the development and enhancement of LIMS and database systems. Show less



Life Technologies

• United States
• Biotechnology Research
• 700 & Above Employee

• Supervisor Manufacturing-Filling, Lab Support and Customs & Specials

  • Oct 2008 - Dec 2010

  Provide leadership and direction to several manufacturing teams (~ 30 people), improving productivity. Work effectively with the manager and team to execute goals, objectives and tasks to achieve desired results. Coordinate team resources to assure the most efficient use of time and materials. Train and coach team members in manufacturing skills and understanding aseptic practices and techniques. Recognize manufacturing problems, identify variables and offer resolutions. Train and coach team members of safe laboratory practices and hazardous materials handling and disposal. Effective communication within the team as well as with other departments, including conflict resolution, team building and scheduling Show less

• Water conservation team leader

  • Oct 2007 - Dec 2009

  2007-2009: initiatives resulted in savings of over 15,000,000 gallons of water annually. "Most Improved Performance" - 2009 EHS Excellence Awards. Member of Carlsbad Green Team: Collaborated on the re-implementation of the Recycling program; participated in planning of Oktoberfest in 10/09 with 600 employees and 6 vendors; currently co-leader for multiple projects: Poster contest, Vendors-Earth day, Bicycle path design.Increased labor utilization to over 89%, increased productivity 29% by merging two teams, and by consolidating supply locations, equipment, training and functions; streamlined process flow.Changed pre-established processes in the Iprep operation to reduce cycle time and QC sampling from 6 to 2.5 days and operators from 4 to 3 per run.Led one of the most efficient teams from 2004-2008: Solutions-QC-VialingRan a Kaizen event for the Filling Room to , create more space for new machines inside the room by identifying and relocating unnecessary itemsAchieved 5S certification for the Vialing Team in September 2009. Show less

• Supervisor Solutions and Lab Support

  • Oct 2004 - Oct 2008

  Manufactured the highest quality product possible, from start to finish (raw materials qualification, production, QC, vialing, assembly, data entry, quality, customer/supplier interaction). Offered alternative production processes and/or schedules in order to improve manufacturing efficiency. Worked with team members and planning/purchasing teams to develop and execute a manufacturing schedule consistent with master schedule requirements for team products. Developed written production documents and technical capable of performing and improving processes and procedures to maintain a great quality on the final products. Show less

• Senior Product Team Assistant

  • Mar 2004 - Oct 2004

  Protein Standards Team Manufacture of Protein Standards; this includes the transformation of cell paste through different purification steps. Trouble shooting of protein bands and quality control of each step.

• Product Team Assistant-Solutions Team

  • Oct 2001 - Mar 2004

  Maintenance of complete and accurate account for manufacturing process through Batch Data Records, Notebooks, work order documents, etc. Revision of process documents and documentation procedures to ensure efficiency and accuracy. Use of different computer programs: E1, Manman, JDE, Project, Microsoft Access, File Maker Data Base. QwikLite Bioassay Software; Graphics Software (including Microsoft Excel, Slide write, PaintShop)



NAVWAR

• United States
• Defense and Space Manufacturing
• 700 & Above Employee

• Navy Scientist-Marine Sciences Dep.

  • Sep 1999 - Oct 2001

  Provided biological support for the Space and Naval Warfare Systems Center, San Diego. Developed new protocols for use in investigations with organisms to assess water pollution. Performed acute and chronic toxicity bioassays with marine organisms to support studies and for novel alternatives being considered for use by the U.S. Navy to determine their degree of toxicity. Design experiments and provide input on new product instrumentation under development. This work resulted in a peer-reviewed scientific paper published in the Marine Pollution Bulletin (December 2007), for which included all summarizes of all toxicity test results on all substances and samples was documented. Show less