Scientist - Formulations (**)

Develop the formulation development plan and execute the R&D laboratory scale experiments using Quality by Design approach for injectable and inhalation formulations for company Clients. Create formulation development plans and execute well-designed experiments to define the qualitative and quantitative formulation composition. Conduct design of experiments (DoE) studies to identify and investigate key and critical quality attributes to confirm formulation robustness as per ICH Q8. Write and execute protocols to prepare formulations for testing and characterization, methods development and technology transfer. Write experimental protocols, execution of experiments, process observations, analytical data collection, data analysis, author formulation summary and product development reports. 2 years experience as a Scientist (Formulation), or related occupation. Must include some experience with: - Pre-formulation research conducted for small and large molecules using solubility, drug excipient compatibility, short terms stability experiments and analyzing the physiochemical characters by conducting microscopy, centrifugation, pH, viscosity, and HPLC studies. - New novel processing equipment and material handling in product development. - GDP and GXP documentation review, editing and mentoring. - Writing Product Development Reports (PDR) and Failure Mode and Effect Analysis (FMEA) documents for ANDA, 505 (b)(2) and NDA filing purposes. - Use of JMP pro software in pharmaceutical formulation and process development, and execution of the experiments in design space. - Development of formulations for solubility enhancement studies with surfactants, solubilizers, co-solvents, preservatives, and antioxidants to attain stable drug products. - Conducting out appearance, microscopy, pH, viscosity, drug release trends from pre-formulation to late stage of R&D, Pre-Clinical & Clinical phases of drug product. - Conducting literature search on pharmaceutical product development on Pubmed, Drugs@FDA, EMEA, and pharmaceutical journals in American Association of Pharmaceutical Scientists (AAPS) and Science Direct databases. Also requires Certification: Lean six sigma Green belt. Master’s degree in Pharmaceutical Science or related field. Foreign equivalents accepted. Please copy and paste your resume in the email body do not send attachments, we cannot open them and email them at candidates at placementservicesusa.com with reference #093843 in the subject line. Thank you.