ProClinical is advertising a vacancy for a Research Scientist position with a leading pharmaceutical company that develops innovative products that address unmet clinical and commercial needs of currently approved molecules through intensive R&D and clinical efforts. This is an exciting opportunity for the Research Scientist to bolster their pharmaceutical career by joining with the company's office in New Jersey.
- Developing and optimizing fit-for-purpose analytical methodologies across early through late-stage product development for injectable and ophthalmic drug products.
- Designing and executing appropriate pre-validation and/or validation studies required to support analytical methodologies.
- Testing various samples in support of formulation development, subsequently followed by interpretation of results to provide meaningful guidance to the team.
- Verifying co-workers' calculations in notebooks/logbooks and verifying results in reports and/or appropriate systems to check for accuracy and integrity of data.
- 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.
- Maintaining inventory of glassware, chemicals, and materials needed for chemical analysis.
- Maintaining and cleaning laboratory instruments and equipment.
- Designing and/or 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 Ph.D. degree in Analytical Chemistry or related field with a focus on mass spectrometry, with 3+ years of experience, or an M.S. with 7+ years of experience, or a Bachelor's degree with 9+ years of experience, or equivalent combination of education and experience is required.
- At least 2 years of experience supporting Analytical R&D in regulated industry, familiarity with ICH Guidelines, and world pharmacopeia (USP, EP) are preferred.
- A proven track record of optimising and developing chromatographic methods by using experimental approaches and/or software-based tools is required.
- Hands-on experience with Waters or Agilent HPLC/UHPLC/GC chromatographic systems and knowledge of Empower software is strongly preferred.
- Primary experience in an R&D environment (as opposed to a QC environment) is strongly preferred, including experience in method development for ANDA and/or 505b2 programs, with an appreciation of fast-paced development workflows.
- Significant experience in the validation of test methods from both a design and execution perspective is required, including having a thorough understanding of regulatory requirements.
- Experience in collaborating with and or leading activities with 3rd party laboratories is preferred.
- Experience with one or more of the following method development software tools:
- ACD LC Simulator
- Fusion LC.
- An understanding of Analytical QbD principles and experience in implementing those is a plus.
- Experience with electronic data systems (ELN, LIMS) preferred but not required.
- Understanding of regulatory requirements pertaining to analytical testing of pharmaceutical products is required, injectable and ophthalmic product experience is preferred.
- Proven record of experience working closely with IT technical team.
- 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 with computer skills, such as MS Office.
- Mid-Senior Level.
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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