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Senior Research Scientist

Company: Aerotek
Location: Bridgewater
Posted on: April 10, 2021

Job Description:

Description: Design and conduct pre formulation, formulation development, process development and process optimization of parenteral and ophthalmic formulations and related alternate drug delivery systems such as solutions, lyophilized products, sterile injectable suspensions etc. Identify the critical process parameters and QTPP's during development and scale up. Conduct literature search for the assigned projects including patent and publications. Establish a close collaboration with different cross functional teams during development and scale up. Author experimental protocols, reports, technology transfer documents and other related documents for submittal to regulatory affairs for dossier preparation. Should be able to travel to CMO Sites for scale up and registration batches as needed.Technical Skills Required: In depth laboratory experience in development of parenteral formulations, ophthalmic formulations and related alternate drug development systems. Knowledge in small molecule chemistry, degradation pathways, characterization and stabilization techniques. Knowledge of DOE's and QBD elements. Through understanding of the pharmaceutical dosage forms such as vials, ampoules, prefilled syringes, infusion bags and lyophilized dosage forms. Experience in the development of sterile suspensions and ophthalmic dosage forms is an added advantage. Experience in development product for NDA or 505b2 NDA regulatory pathway Experience in Technology transfer from research and development scale to pilot/commercial scale. Trouble shooting abilities to resolve issues during development and scale up. Author experimental protocols, reports and technology transfer documents and other documents as needed for dossier purposes. Strong verbal and written communications skills. Ability and willingness to work in a cross functional team environment. Must be capable of working in a fast-paced environment in order to meet project timelines.Experience:Ph.D. in Pharmaceutical Science with 2-3 of experience or M.S in Pharmaceutical Science, with 3-5 years of experience in injectable drug development.Skills:injectable formulation, parenteral, ophthalmic, preformulation, scale-up, drug development, designing experiments, protocol, submissionMust Haves:Injectable Formulation, Scale-up, drug development About Aerotek:We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Keywords: Aerotek, Trenton , Senior Research Scientist, Other , Bridgewater, New Jersey

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