Formulations Supervisor - Berkshire Sterile Manufacturing
(2022-07)
- Responsible for lab setup and process flows
- API dissolution and final QS while ensuring safety
- Batch integrity and prevention of errors that could lead to product and/or financial loss
- Maintain weekly/daily schedule
- Communicate and maintain the thaw/equilibration schedules for chemicals and/or equipment
- Train team members and ensures proper training is completed prior to assigning tasks
Lead BioProcess Associate - Emergent BioSolutions
(2021-11 - 2022-07)
- Operates pharmaceutical manufacturing equipment such as: incubators, wave reactors, single-use bioreactors, depth filtration skids, TFF skids, chromatography skids, single-use mixers and in process testing equipment
- Demonstrates, understands and adheres to Emergent policies, GMP standards and safety procedures
- Troubleshoot, advanced maintenance and repair activities on equipment and systems used in Manufacturing according to Standard Operating Procedures (SOPs)
- Perform and monitor critical processes, execute routine validation protocols, work orders
- Informs supervisor/ manager on progress of projects, transfer of data, process details, etc.
- Executes batch records according to GMP and site quality standards
- Generates Batch Records, SOPs and Protocols as required
- Responds to off-hour alarms as assigned by supervisor/ manager
- Executes manufacturing cleanroom changeover and activation
- Supports Validation, Engineering and Facilities personnel in start-up, testing and operation of manufacturing process equipment
- Supports QA during audits and regulatory inspections
- Supports other manufacturing process teams and other groups as necessary to achieve Manufacturing team goals
Biotech Production Specialist - Regeneron Pharmaceuticals
(2021-04 - 2021-10)
- Ensures equipment operational readiness
- Performs various tests and analytical procedures
- Documents all training
- Must be able to push, pull and lift 50lbs
Associate Biotech Production Specialist - Regeneron Pharmaceuticals
(2019-07 - 2021-04)
- Assists/contributes in all areas of production as needed
- Monitors production processes
- Reviews, edits, completes, and revises completed batch records, Logbooks, and SOPs in accordance with cGMP standards and compliant with written procedure
- Ensures equipment operational readiness
Process Sciences Associate (Downstream) - Regeneron Pharmaceuticals
(2018-05 - 2019-06)
- Drafts study protocols and author study reports for manufacturing support and scientific studies
- Conduct small-scale lab operations, perform statistical analysis of data, and present results in crossfunctional meetings
- Provides technical support for manufacturing operations
- Serves as a subject matter expert (SME) for manufacturing downstream operations, data analysis and manufacturing support activities
- HPLC: protein separation, filtration, and purification
- Training in cGMP
Information Technology Specialist - United States Army
(2014-04 - 2018-03)
- Provide customer and network administration services
- Construct, edit and test computer programs
- Maintenance of networks, hardware and software
- Planning, designing and testing computer systems
- Computer systems concepts
- Use of computer consoles and peripheral equipment
Quality Control Chemist (Temporary Contract) - Balchem Corporation
(2013-10 - 2014-03)
- Analyzing production samples making sure they fall into compliance
- Checking raw materials making sure they fall into compliance
- Titrating Samples and Testing Conductivity
- Analyze WIPs materials for release and every 5th sample for activity
- Particle size using acid-base redox titrations
- Used autotitrators and water activity meters
- Prepare and standardize laboratory reagents
Packaging - Novartis Pharmaceuticals
(2012-10 - 2012-12)
- Packaging Coartem in bottles
- Training in cGMP
- Evaluate, select, and implement major packaging systems
- Write and/or check packaging material specification sheets
