Position: Analytical Development Senior Scientist
Location: Cumberland, RI
To acquire knowledge by performing extensive literature search from various available resources. To review RFP and provide inputs as required. Involved in planning research activities and experiments that support the development of methods for analysis of new products or modification of existing products to meet customer specifications and regulatory requirements. Provide research based, strategic solution to develop and validate analytical methods which will optimize project performance and comply to USFDA and other regulatory requirements. Involved in critical thinking and testing to determine the appropriate solutions for the challenges in a project. interpret and analyze experimental data to identify the next steps to be taken. Involved in evaluating, developing, routine testing and validating the methods for immediate release or extended release formulations (tablets, capsules, pellets etc.). Involved in handling of controlled substances Schedule I (R & D) to Schedule V. Involved in abuse deterrent testing as required. Assists in evaluation and testing of raw materials, in-process and finished dosage forms. Communicate internally and externally with project clients/stakeholders, suppliers and internal staff to support project advancement and improving transparency & distributing timely information about the project. Managing multiple projects simultaneously. Provide updates as required to production, QA, RA and QC departments and to clients. Assist Manager in providing strategic inputs for the project advancement. Review technical documents in collaboration with other scientists and formulation development for laboratory notebooks, batch records, project summaries, development reports, sampling and testing protocols, planned deviation reports, incident reports, and change control forms. Support and coordinate the recruitment process of new hires and the development of team. Supervise/train junior analytical chemists or scientists, technicians and ensure their activities comply with organizational goals and departmental cGMP/ cGLP regulations. Assists in FDA filings.
Requires a Master’s degree or foreign equivalent in Pharmaceutical Sciences, Chemistry, or a related scientific field. Position also requires a minimum of 1.5 years of directly related pharmaceutical experience in solid oral dose, solid oral dose testing and method development/validation.