Lara Ebert Email & Phone Number

Burnaby

Responsibilities can be divided into two main categories:1. Provide process development and engineering solutions to R&D projects during scale-up and transfer to clinical production by:- Supporting all aspects of scale-up and technology transfer of projects from R&D to clinical manufacturing- Selecting and/or sourcing equipment based on key parameters- Developing procedures, master batch records (MBR), and protocols to support the execution of batches/ equipment.- Supporting manufacturing of Engineering, Test Articles, and GMP clinical manufacturing batches as the SME on equipment and processes.- Working directly with team members and equipment to train or execute batches. 2. Development / continuous improvement of core manufacturing processes by- Establishing baseline procedures and batch record instructions. Document learnings during execution, and implement improvements.- Assessing and implementing standard processes, allowing Formulation and Development Teams to focus on project-specific development.- Adapting processes in response to changing customer portfolio and expectations. Strategically implement CAPEX to improve processes.- Establishing and maintaining tools to guide Formulation and Development Teams when writing GMP documentation during the transfer of their programs to clinical production.- Training GMP Manufacturing Operators on the execution of core processes in the cleanroom. Support troubleshooting activities during batch execution.

Annacis Island

• Run production chemistry, column, rotary evaporator, and crystallization to obtain Active Pharmaceutical Ingredients (API) Paclitaxel and Docetaxel.• Operate and clean glass and stainless steel reactors, rotary evaporators, crystallizer, filter drying units, charge pots, carboys, and glassware between each manufacturing session.• Use a glove box for sampling and packaging primary taxanes and crude Paclitaxel.• Follow Batch Records according to current Good Manufacturing Practices (cGMP) regulations.• Work closely with Quality Control (QC) for sampling and obtain results for crude, intermediates, and API Paclitaxel and Docetaxel.• Work closely with Quality Assurance (QA) and Logistics for the release of materials, the release of the production labs, and for the quarantine of API materials.• Write and update Standard Operating Procedures (SOPs) for the Production Team.• Write deviation reports when they arise and investigation reports if required.• Help train and mentor junior members on the team.• First Aid Level 1• Write and update System Requirement Specification (SRS) for new and existing equipment.• Write and perform Installation, Operation, Performance Qualification (IOPQ) protocols for new and existing production equipment.• Write IOPQ reports once qualifications are completed.• Perform regular calibration and maintenance events on Production equipment such as but not limited to reactors, pumps, balances, chillers, heat sealer.

Delta

• Followed SOPs to run the HPLC and GC on in house samples to determine purity and ratios of solvents.• Accurately filled out the appropriate paper work, according to cGMP, required for each sample after specified tests were completed.• Ran specific rotation and infrared spectroscopy on final and raw materials.• Recorded training records and various test in a lab notebook.

• Analyzed various drug combinations for total content, purity, and stability using HPLC.• Completed HPLC Method Development and Force Degradation studies.• Ran SDS-PAGE on stability samples.• Performed daily tasks including sample preparation, processing results, and reporting results.• Presented results to a large group through Power Point Presentations.• Followed compliances while working in QC and Analytical Development (AD) labs.• Helped set up a lab for cGMP.• Consistently and accurately recorded laboratory observations and results in a laboratory notebook.