The Pharma Method Development and Validation Chemist will perform studies for the development of immediate release and controlled release tablet and capsules dosage formulations, topical formulations (creams and gels) and liquid formulations.
Develop methods per ICH/USP requirements for excipient, API and final formulations of solid oral dosages form.
Writes method protocols for full validation and verifications to USP methods.
Does forced degradation studies.
Can make a method from scratch and or improves such by fine tuning the method parameters to meet USP or vendor specifications.
Works with QC to due testing . However, main job is taking a tech pack and making method validation protocols for submitting into ANDA .
Perform testing on raw materials and in-process and finished dosage forms.
Write technical documents including laboratory notebooks, batch records, project summaries, development reports, sampling and testing protocols, planned deviation reports, incident reports, and change control forms.
Maintain technical documents in the formulation development department.
Calibrate in-process testing equipment, interpret and analyze experimental data, identify the next steps to be taken and perform scale-up and technology transfers of formulations from research and development to the submission/clinical to production/commercial scale batches.
Direct the work of scientists and technicians in the formulation department, reviewing their laboratory notebooks, batch records, project summaries, product development reports and standard operating procedures.
Attend project meetings.
Manage R&D projects and report project progress to the project manager.
Communicate the status of various batches to the production, QA, RA and QC departments and to clients, as needed.
Assist in FDA filings.
Review project contracts.
Assist IT in development and implementation of the database system.
Bachelor's Degree in Chemistry required.
Proficiency in computer usage and Microsoft Office required.
Job Type: Full-time
Required experience: Chemistry: 4 years
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