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
...Job Description Starting hiring pay at: $$15.50 As an important part of our team, Customer Service Associates impact all areas of the customer experience. As the name suggests, your main priority is to provide great customer service. In this role, you will be responsible...
...Retool, NBA, Plaid, and LOreal. Were based in San Francisco and are remote-friendly. Hightouch is backed by leading investors such as Amplify Partners, ICONIQ Growth, Bain Capital Ventures, Y-Combinator, and Afore Capital. About The Role Are you skilled at breaking...
...Job Description Triage Staffing is seeking a travel nurse RN PreOp / PACU - Post Anesthesia Care for a travel nursing job in Denver, Colorado. Job Description & Requirements ~ Specialty: PreOp / PACU - Post Anesthesia Care ~ Discipline: RN ~ Start Date:...
...hospitality, Orient Express places particular emphasis on the employee experience, development, and engagement. Orient Express Sailing Yachts 140 years after the launch of its first luxury trains, the Orient Express legend continues with the launch of the world's largest...
...seeking business-minded professionals who are ready to take over the world! Were looking to hire both licensed and non-licensed life insurance agents. Were hiring for full or part-time. What were looking for is People who are-Driven to Succeed -Self-Motivated -...