Associate Scientist - Analytical
ProClinical is advertising a brilliant opportunity for an Associate Scientist - Analytical vacancy to be based in New Jersey. This job will be with a renowned pharmaceutical industry that develops innovative products in the injectable and ophthalmic space.
- Developing fit-for-purpose analytical methodologies across early through late stage product development.
- Designing and executing appropriate pre-validation and/or validation studies required to support analytical methodologies.
- Testing various samples in support of the formulation development.
- Preparing reagents, standards, etc., needed for analysis.
- Evaluating compendial and other published methods and supporting new method development activities.
- Interpreting and tabulating results of analysis; recording the results in approved notebooks, reports, and logbooks.
- Performing basic statistics to support analytical testing.
- Helping receive and store receipts of solvents and analytical reagents.
- Verifying co-worker calculations in notebooks/logbooks and verifying results in reports and/or appropriate systems to check for the accuracy and integrity of data.
- Ordering supplies as needed.
- Maintaining inventory of glassware, chemicals, and materials needed for chemical analysis.
- Maintaining and cleaning laboratory instruments and equipment.
- Reading and executing departmental methods, protocols, and SOPs.
- Assisting in writing, reviewing, or revising procedures.
- Performing other laboratory related miscellaneous duties as required.
Skills and Requirements:
- A BS or BS in a scientific field.
- At least three years of experience in an analytical laboratory.
- Familiarity with ICH Guidelines and world pharmacopeia (USP, EP) are preferred.
- Significant chromatographic experience is required, with preference given to hands-on experience with Waters and Agilent HPLC/UHPLC/GC chromatographic systems and knowledge of the Empower software.
- Primary experience in an R&D environment (as opposed to a CQ environment) is strongly preferred, including experience in method development for ANDA and/or 505b2 programs with an appreciation of fast-paced development workflows.
- Experience in the validation of test methods both from a design and execution perspective.
- Experienced in secondary analytical testing methodologies are appreciated, but not required (for example, dissolution, drug release, particle size, etc).
- A thorough understanding of regulatory requirements pertaining to analytical testing of pharmaceutical products is required, with preference for injectable and ophthalmic product experience.
- Experience with electronic data systems (ELN, LIMS) preferred but not required.
- Knowledge of safety and hazardous waste requirements.
- Desire to learn new techniques and methodologies with a goal to implement those in the lab.
- Capable of working independently, analysing, working with attention to detail, process and prioritise sensitive complex information, and solve problems.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency in MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Mary Jacobs at +267-477-4800 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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