Analytical Development Chemist

Tedorpharma; Cumberland (RI); On-site; USD 75,000 - 95,000; Full time

Job summary

A pharmaceutical company in Rhode Island is looking for a Pharma Method Development and Validation Chemist. This full-time position involves developing and validating methods for various formulations, maintaining technical documents, and managing R&D projects. A Bachelor's Degree in Chemistry and 4 years of experience in the field are required.

Qualifications

• 4 years of experience in Chemistry is required.

Responsibilities

• Develop methods per ICH/USP requirements for various formulations.
• Writes method protocols for validation to USP methods.
• Perform forced degradation studies.
• Improve methods through fine-tuning.
• Works with QC for testing and creates validation protocols.
• Handle technical documentation including project summaries.
• Calibrate in-process testing equipment and analyze data.
• Direct scientists and technicians, reviewing their work.
• Manage R&D projects and report on progress.
• Assist in FDA fillings.
• Assist IT in implementing database systems.

Skills

Proficiency in computer usage

Microsoft Office

Education

Bachelor's Degree in Chemistry

Job description

Overview

The Pharma Method Development and Validation Chemist will perform studies for the development of immediate release and controlled release tablet and capsule dosage formulations, topical formulations (creams and gels) and liquid formulations.

Responsibilities

• Develop methods per ICH/USP requirements for excipient, API and final formulations of solid oral dosage forms.
• Writes method protocols for full validation and verifications to USP methods.
• Performs forced degradation studies.
• Can make a method from scratch and/or improve such by fine tuning the method parameters to meet USP or vendor specifications.
• Works with QC to perform 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 fillings.
• Assist IT in development and implementation of the database system.

Qualifications

• Bachelor's Degree in Chemistry required.
• Proficiency in computer usage and Microsoft Office required.
• Job Type: Full-time
• Required experience: Chemistry: 4 years

Seniority level

• Entry level

Employment type

• Full-time

Job function

• Research, Analyst, and Information Technology

Industries

• Pharmaceutical Manufacturing