1+ months

Analytical R&D Senior Scientist

Kelly Services
Pine Brook, NJ 07058
**Analytical Research & Development (ARD) Scientist**

**Location: Pine Brook, NJ**

**The Scientist is primarily responsible to perform the following tasks independently.**

+ Related Compounds method development for peptides.

+ SEC-HPLC method development for analysis of aggregates in peptides.

+ LCMS sequencing of peptides.

+ Amino acid profiling/quantitation for peptides.

**The following requirements are desirable but not must:**

+ Performs various analytical testing, including dissolution, HPLC and GC testing following established testing procedures for raw materials, finished products, and/or stability samples.

+ Performs method validation independently, including protocol and report writing and reviewing.

+ Performs method development, including HPLC, GC, Dissolution, UV, XRPD, SEC, PSD, Viscosity, etc., as well as methods using more advanced analytical technique for small molecules.

+ Identifies critical method attributes. Identifies, develops, and justifies methodology and specifications supporting API and finished products under development.


+ Hands-on experience on various method development for peptide analysis, including related compounds methods, is must.

+ Hands-on experience on method development, improvement, and validation, including but not limited to HPLC, GC, Dissolution, LC-MS, GC-MS, XRPD, PSD, Viscosity, SEC, etc., as well as compendial tests. instrument trouble shooting

+ Be a skilled experimentalist in various analytical method development to support the needs of product development for large molecule drugs.

+ Independently performs unknown impurity identification study and material characterization study.

+ Prioritizes activities to provide timely analytical support to product development. Anticipates analytical issues early in the R&D development process and provide long term planning for analytical method development and improvement.

+ Performs quantitative and qualitative LC-MS analysis, and IVIVR dissolution method development.

+ Reviews data, design and execution of experiments, and interprets results to define solutions, identify new methods to enhance the analytical capacity.

+ Demonstrates comprehensive understanding and use of scientific principles and professional practices to solve a wide range of complex problems in creative and practical ways.

+ Participates in design and review protocol outlines, reviews results and finalizes reports.

+ Delivers and communicates accurate results to project teams, provides intellectual input, and contributes to decision making.


+ PhD, MS or BS in Chemistry, Biochemistry or related discipline with 4+ years (PhD) or 7+ years (MS), or 10+ years (BS) of experience in pharmaceutical industry or CROs.

+ Experience in analytical techniques including UV-Vis, RI, Fluorescence detection, HPLC, SEC, LC-MS, CE, CD spectroscopy, GC-MS, NMR, KF, FTIR, DSC etc. and advanced analytical technique.

+ Must have recent working experience in analytical method development for large molecules including peptides.

+ Good understanding of regulatory requirements: ICH, USP/EP/JP etc.

+ Ability to work independently and manage projects in a timely manner.

+ Understanding of cGXP requirements preferred.

+ Strong organization, communication and interpersonal skills.

**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

**Why Kelly** **** **?**

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (
Posted: 2022-07-13 Expires: 2022-09-12

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Analytical R&D Senior Scientist

Kelly Services
Pine Brook, NJ 07058

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