Associate Scientist

Overview

Perform HPLC/UHPLC/CE analytical testing and method transfer for drug development.

Key Responsibilities

• method transfer
• forced degradation
• hplc qualification
• process validation
• platform evaluation
• trend analysis

Tasks

-Hand-off/transfer of testing to our Rapid Analytics teams. -Perform forced degradation studies to support product characterization understanding of product stability and evaluation of product comparability. -Performing HPLC/UHPLC and CE method qualification studies to support transfer of methods to pivotal Quality Control teams. -Transition of analytical methods from our early-stage development teams to the pivotal testing laboratory. This will include interfacing with attribute sciences team leads and early stage development teams performing method assessment / qualification method optimization and formatting chromatography data software methods. -Closely collaborate with partner organizations during commercial process development process characterization and process validation studies to support marketing applications. -Evaluation of novel platform methodologies to improve testing efficiencies in the Process Analytics and Rapid Analytics teams. -Performing high-sample volume testing by High Performance Liquid Chromatography HPLC Ultra High-Performance Liquid Chromatography UHPLC Capillary Electrophoresis CE and Tecan in support of Drug Substance Drug Product and Attribute Sciences process development teams under prescribed timelines. Full documentation of analyses in electronic lab notebook. Performing tracking and trend analysis of method performance.

Requirements

• 1-2 years
• b.s. chemistry
• hplc
• chromatography
• waters empower
• gmp

What You Bring

-1-2 years of experience in a pharmaceutical/biotech analytical lab. -Understanding of phase-appropriate GMP compliance and documentation -Familiarity with analytical techniques used in late-stage drug development. -Hands-on experience with chromatography HPLC strongly preferred. -Good general biochemistry laboratory skills -Strong desire to learn and interest in science -Basic sample preparation and testing in a regulated lab environment. -Working knowledge of chromatography including HPLC UPLC and CE -B.S. in Chemistry or Biochemistry -Well-organized ability to multitask effectively plan and follow through on complex projects and to work both independently and in teams -Background in chromatography data software Waters Empower Thermo Agilent softwares and/or automation software Tecan -Demonstrated proficiency in execution of test methodology following a defined procedure. -Working knowledge of compendial methods testing such as Karl Fischer Color/Clarity and UV/VIS spectroscopy

People Also Searched For

Benefits

-Critical Illness, Accident, and Hospital -Life Insurance (Voluntary Life & AD&D for the employee and dependents) -Medical, dental & vision -Transportation benefits -Health Spending Account (HSA) -Time Off/Leave (PTO, Vacation or Sick Leave) -Employee Assistance Program -Short and long-term disability -401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available

About Actalent

-Born in July 2021 by merging Aerotek’s engineering & sciences arm with EASi, Actalent emerged as a focused engineering-and-science partner. -Backed by Allegis Group, it drives scale and speed to market via contract, managed, and technical services. -Headquartered in Maryland with global reach, it deploys specialized teams across North America, Europe, and APAC on Fortune 500 projects. -Typical engagements span EV design, vaccine development, lab services, clinical research, and infrastructure systems. -Expertise covers a wide spectrum: aerospace, defense, healthcare, manufacturing, software systems, environmental and civil engineering.

Sector Specialisms