Research & Development Assistant / Associate

Company

 CuriRx, Inc. was founded in 2012 with the goal of creating new standards of care in therapeutic areas with high unmet medical needs. We do this by partnering with our clients to provide innovative development solutions for pharmaceutics, biopharmaceutics, vaccines, generics, and biosimilars. CuriRx focuses on formulation and lyophilization development of biologics, small molecules, analytical development, and biomanufacturing process development.

Job Description

      The Research & Development Assistant / Associate is a hands-on laboratory position that will contribute to various aspects of analytical testing, biologic drug formulation development, and related research activities. The successful candidate will support or contribute to projects involving drug candidate screening, analytical method development, pre-formulation studies, formulation development, compatibility studies, and stability studies.

Depending on experience level, the candidate may assist with or independently perform analytical testing, method development, and formulation development activities for injectable, liquid, and lyophilized pharmaceutical and biologic products, including generics and biosimilars. The candidate will effectively communicate results through technical reports, presentations, and cross-functional meetings.

Duties and Responsibilities

·       Assist with or contribute to the development of analytical methodologies.

·       Generate, review, compile, and interpret analytical data.

·       Document, analyze, interpret, and present analytical testing data in a clear and concise manner.

·       Execute laboratory experiments and maintain accurate laboratory documentation.

·       Support process and method validation activities consistent with GxP requirements.

·       Participate in the development of new technologies, processes, and formulations for injectable pharmaceutical and biologic products.

·       Assist with or contribute to pre-formulation studies, formulation development, process development, process optimization, scale-up, and manufacturing activities.

·       Support troubleshooting and problem-solving efforts related to analytical and formulation development projects.

·       Assist with the preparation and review of SOPs, protocols, development reports, and batch records.

·       Support equipment qualification, maintenance, and evaluation activities.

·       Collaborate with project teams to support project objectives, timelines, and deliverables.

·       Depending on experience level, may provide guidance to interns, co-ops, or junior staff.

·        Maintain awareness of scientific and industry developments through literature review and continuing education.

Required Qualifications

Research & Development Assistant

·       BS in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, Biology, Chemical Engineering, or a related scientific discipline.

·       0–2 years of relevant laboratory experience (industry, academic, internship, or co-op experience considered).

·       Basic understanding of analytical techniques and laboratory practices.

·       Strong attention to detail and ability to follow experimental protocols.

·       Excellent organizational, communication, and problem-solving skills.

Research & Development Associate

·       BS in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, Biology, Chemical Engineering, or related discipline plus 2–5 years of relevant industry experience; or

·       MS in a related scientific discipline plus 0–3 years of relevant industry experience.

·       Experience with formulation development, analytical development, process development, or pharmaceutical manufacturing.

·       Ability to independently troubleshoot, analyze, and interpret scientific data.

Preferred Qualifications

·       Experience with injectable dosage forms.

·       Experience with analytical instrumentation such as HPLC, LC-MS/MS, spectrophotometers, plate readers, fluorimeters, moisture analyzers, and related laboratory equipment.

·       Experience with Design of Experiments (DoE/QbD).

·       Experience in formulation development, process development, and/or manufacturing.

·       Experience with lyophilization development.

·       Familiarity with FDA regulations and pharmaceutical product development.

·       Knowledge of NDA, ANDA, and/or 505(b)(2) regulatory submissions is a plus.

If you have the required experience and skills to succeed, and you are seeking a challenging opportunity in a growing company with a dynamic culture, send your resume.

CuriRx is an equal opportunity employer and supports workplace diversity, a reduced carbon footprint, and fun.