Job Description

Job Title: Sr. Research Scientist (ARD/QC)

Location: Onsite, Cranbury NJ

Position Type: Full-Time

Reports To: Director, Analytical R&D/QC

Job Summary

:We are seeking a highly motivated Sr. Research Scientist to join our Analytical R&D and QC department within the CDMO (Contract Development and Manufacturing Organization) industry. The ideal candidate will have a strong background in analytical chemistry and experience in method development, validation, and quality control testing

.
Key Responsibilitie

s:Conduct analytical method development and validation independentl
y.Troubleshoot analytical methods as needed and gain more experience in the related are
a.Conduct release testing for GMP regulatory starting materials, intermediates, and final API
s.Conduct testing for stability studies and cleaning verificatio
n.Review test data to ensure completion and accurac
y.Write raw material test procedures as needed under supervisio
n.Write SOPs and protocols as needed under supervisio
n.Write instrument operating, maintenance, and qualification/calibration procedures as neede
d.Participate in OOS and deviation investigations, as neede
d.Support Quality Assurance as needed during internal audits and audits by clients and regulatory agencies. Assist in the development and implementation of corrective actions related to QC/A
D.Troubleshoot and maintain analytical instruments. Ensure that instrument calibration and qualification intervals are curren

t.
Qualificatio

ns:BS, MS, or PhD in Analytical Chemistry, Chemistry, Pharmaceutical Sciences, or a related fie
ld.3+ years of experience in analytical R&D and/or QC within the pharmaceutical or CDMO indust
ry.Strong knowledge of analytical techniques, including HPLC, GC, UV-Vis spectroscopy, and dissolution testi
ng.Familiarity with method validation protocols and regulatory requiremen
ts.Excellent problem-solving skills and attention to deta
il.Strong communication and interpersonal skills, with the ability to work effectively in a team environme
nt.Proficient in data analysis software and laboratory information management systems (LIM

S).

Job Tags

Full time, Contract work

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