Senior R&D Scientist, Analytical Chemistry

Job Description

Job Descriptionjob summary:

As a Senior Formulation/Process Scientist in Central Islip, NY, you will be a key SME on analytical methods, driving the development of new pharmaceutical products. This individual contributor role is responsible for independently developing, assessing, and validating analytical test methods, leading projects related to extractables and leachables (E&L), and providing technical support for product development from pre-formulation through to FDA submissions.

This is a permanent role on-site in Central Islip, NY.

Relocation Candidates welcome to apply.

location: Central Islip, New York
job type: Permanent
salary: $90,000 - 105,000 per year
work hours: 9 to 5
education: Doctorate

responsibilities:

• Operate as the subject matter expert (SME) on analytical methods for products that are under development, products that are commercialized and in support of process analytical technologies (PAT) for commercial manufacturing processes.
• Operate as the subject matter expert (SME) on analytical methods for various internal and external projects. Independently develop, assess and/or verify and validate analytical test methods for APIs, excipients, packaging components, devices and drug products using industry standard methodologies including QbD principles for analytical methods; US FDA or EU guidance's and requirements; United States Pharmacopoeia (USP) guidelines; International Council for Harmonization (ICH) guidelines. Techniques may include standard tools like HPLC, UPLC, UV, GC, LC-MS, Viscometer, Karl-Fisher, IR, Particle size analyses, XRPD, DVS, Rheometer etc. to more specialized techniques such as LS-MS/MS, NMR, SS-NMR, Synchrotron etc.
• Lead and define strategy on all topics extractable and leachables (E&L).
• Evaluate material from new vendors for suitability of material based on physico-chemical properties and perform studies in support of vendor qualifications.

qualifications:

EDUCATION AND EXPERIENCE

• PhD in Analytical Chemistry, Pharmaceutical Chemistry, Organic Chemistry or Medicinal Chemistry or scientific degree.
• Hands-on wet lab experience
• 1+ years of experience in HPLC
• 1+ years of experience in Karl Fischer titration
• 1+ years of experience in inhalation toxicology

#LI-AB1

skills: Liquid Chromatography (LC), Karl Fischer (KF) Titration

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).

This posting is open for thirty (30) days.