Kilo Lab Manager / Responsable Kilo Lab / Kilo-Labor Produktionsleiter

• Mar 2021 - Present

• Responsible for the overall operations of the Kilo Lab from PO signature to product delivery and beyond to post-delivery client support.• Collaborate with Quality Assurance to ensure compliance with safety protocols, standard operation procedures (SOPs), and regulatory requirements.• Participate in External and Internal Regulatory and Quality Audits as the Process Design/Kilo Lab SME.• Lead the Kilo Lab training program to ensure chemists and lab operators are successfully in daily operations.• Plan and coordinate the execution of kilo lab projects including process development, scale-up, and technology transfer activities.• Develop and implement process validation protocols and strategies to ensure the reliability and reproducibility of kilo lab processes.• Develop Preventative Maintenance procedures for Kilo Lab Equipment.• Manage Inventories of Raw Materials, chemicals, equipment, and disposables. This includes the implementation and maintenance of a 5S organizational system.• Write and review Master Processing Records for Active Pharmaceutical Ingredients. Show less

Chemical Process Engineer

• Jan 2019 - May 2021

• Responsible for scale-up and development of processing instructions for plant operations. Responsible for project start up, process optimization and process troubleshooting .• Traveled to and Observed Kilo scale process' for scale up at the Research and Development Site.• Participated in PHA Program to ensure all incoming and existing process' are analyzed for safe operations. This is also required under specific circumstances for OSHA PSM.• Managed customer relationships to ensure customer satisfaction and repeated business.• Ran 10+ manufacturing process' as lead engineer.• Assisted in multiple Internal Audits including Audits of Quality Control, and Chemical Storage Warehouse.• Assisted in running of the maintenance Work Order program.• Led the redevelopment of SEQENS NA cleaning system by revising MACO (Maximum Allowable Carry Over) forms to fit a more efficient plan.• Responsible for ensuring cleaned equipment is available for use in production process'. Including but not limited to; material of construction (MOC) checks, method validation checks, developing cleaning justifications and protocols, and troubleshooting when cleanings do not go to plan.• Investigated quality deviations from manufacturing, maintenance, and engineering process' to ensure the correct preventative actions were taken.• Covered all shifts(first, second, and third) when required to ensure production process' go as smoothly as possible.• Assisted in the management of the GMP Kilo suites during management change-over. Show less

Senior Driver

• Feb 2016 - Jan 2019