Job Type
Full-time
Description
Summary
This position is primarily responsible for the laboratory testing of raw materials, packaging materials, in-process, release and stability samples for developmental and pre-commercial drug products, including the evaluation of new raw materials, new packaging materials, reference standard qualifications, method transfers, and develop and validate methods within the framework of cGMP compliance guidelines.
Responsibilities
• Perform routine and non-routine physical and chemical tests and assays on raw materials, API's, in-process, finished products, experimental batches and associated stability studies
• Testing performed to include basic and complex lab equipment and procedures, such as pH, Loss on Drying, Residue on Ignition, Water Content by Karl Fischer, Assay/Impurities by HPLC, Dissolution, Residual Solvents by GC, and wet chemistry techniques such as titrations and sample derivatizations
• Conduct analytical research and develop analytical methods to test pharmaceutical products for conformance to established specifications with some supervision.
• Develop and validate analytical test methods for assay, dissolution, preservatives in drug products according to ICH/FDA/USP requirements with minimal to no supervision.
• Develop and validate test methods for residual solvents and impurities/degradation products in drug substances/excipients/drug products according to ICH/FDA/USP requirements under some supervision
• Develop and validate analytical Cleaning Validation methods and perform testing of cleaning validation samples and generate analytical report with minimum supervision.
• Multi-task by working on several simultaneous projects. Develop project timelines.
• Document all laboratory testing and maintain accurate and legible notebooks and records
• Perform peer review on other analysts' data.
• Provide regular update progress reports of projects
• Comply with all relevant regulatory requirements
• At all times strive to maintain the self-esteem of individual team members and the professionalism of the group as a whole
• Perform laboratory troubleshooting, propose solutions and implement
• Other projects and duties as required or assigned
• Provide technical input for purchase of new/updated laboratory instruments and software systems
• Train other laboratory chemists on analytical instrumentation and methods.
Mentor/Train team members on new/revised skills and testing procedures
Requirements
Experience
Skills
...Veterinary Practice Director -Seattle, WA area We are seeking an experienced veterinary practice manager and leader to step into a role to lead a team of passionate, focused doctors. The business is an all-inclusive, pet hospital, daycare, grooming, and boarding service...
...Business Function DBS Private Banking offers a one-stop, full-service touch-point for total banking requirements and provides the highest... ...Strong knowledge of PB investment products including equities, fixed income, managed solutions, FX and structured products...
...Machine Operator Are You a Dependable Insert Operator with Speed, Precision, and Production Expertise located in North Phoenix? Apply Now... ...equipment and ensure high-quality, accurate production output Load machines with required materials (mailers, pamphlets,...
Position Overview We are seeking a highly skilled Field Service Engineer to install, commission, maintain, and troubleshoot industrial material handling and process equipment at customer manufacturing facilities across North America. This full-time, permanent role is...
...Weekend Opportunities Available Locations: Hudson, New Port Richey, Land O' Lakes, & Bayonet Point, Florida Compassion Starts with... ...'d love to hear from you. Qualifications Current Florida CNA license or Home Health Aide (HHA) certification, or qualifying caregiving...