Analytical Research Chemist

Description:

1. Position Summary: • Perform materials and drug physical and chemical characterizations using HPLC, GC, SEC, LS, PM, FTIR; method development, validation, implementation, testing, reporting and method transfer to support pharmaceutical R&D, CMC. • Support regulatory filing for drug compounds and formulations. 2. Position Responsibilities • Analytical characterizations, development/validation of analytical methods for polymers, APIs and formulated drugs, stability testing and method transfer to manufacture unit and CMO • Perform materials and drug physical and chemical characterizations using HPLC, GC, SEC, LS, PM, FTIR, osmometer, viscometer, as well as equipment maintenance and calibration • Writes R&D reports and summary of all QC effort on new drug development • Works in collaboration with development and manufacturing colleagues to implement analytical controls, and support manufacturing and testing at CRO/CMO • Delivers analytical source document for CMC sections of IND/NDA filings. Addresses technical inquiries from regulatory agencies to support clinical trial and commercial marketing applications • Collaborates with R&D and manufacturing teams to define new drug’s physical-chemical and quality attributes, testing methods, stability profiles, product performance characteristics and specifications • Works closely with R&D, manufacturing, quality and operation team on company process improvement • Adheres to safety and security standards and company's Standard Operating Procedures • Performs other duties as assigned, such as assay development

Skills:

HPLC, GC, FTIR, method development, method transfer, development, research, synthesis, method validation, characterization

Top Skills Details:

HPLC,GC,FTIR,method development,method transfer,development,research,synthesis,method validation,characterization

Additional Skills & Qualifications:

• Bachelor of Science degree with minimum 1 years of post-bachelorette laboratory experience • 1+ years of experience in analytical chemistry handling analytical equipment • Ability to take initiative, to maintain confidentiality, to meet deadlines, and to work in a team environment • Experience with various analytical equipment (HPLC, GC, FTIR, UV/Vis, etc.) • Demonstrated ability to think innovatively based on previous work and publications. • Knowledge and awareness of current progress in a wide range of scientific research and development related to the company’s product focus. • Oral presentation skills • Ability to conduct independent research • Pharmaceutical experience & familiarity with cGMPs ***Must have 3.2 GPA or higher***

Experience Level:

Intermediate Level

About Actalent:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Company
ACtalent
Posted
01/15/2022
Type
Contractor
Salary Range
$74,000.00 - 110,000.00
per Year
Salary range estimated by
Location
Newark, DE, US
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