Top Skills' Details:

　　• Good general biochemistry laboratory skills

　　• Working knowledge of chromatography including HPLC, UPLC,

　　• Working knowledge of compendial methods testing, such as Karl Fischer, Color/Clarity, and UV/VIS spectroscopy

　　** Ideal candidate: B.S degree in chemistry/ biochemistry highly preferred w/ 1 year of experience (academia w/ relevant experience is OK)

　　Description:

　　• 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.

　　• 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.

　　• Hand-off/transfer of testing to our Rapid Analytics teams.

　　• Evaluation of novel platform methodologies to improve testing efficiencies in the Process Analytics and Rapid Analytics teams.

　　• Performing HPLC/UHPLC and CE method qualification studies to support transfer of methods to pivotal Quality Control teams.

　　• Perform forced degradation studies to support product characterization, understanding of product stability and evaluation of product comparability.

　　• Closely collaborate with partner organizations during commercial process development, process characterization and process validation studies to support marketing applications.

　　Additional Skills & Qualifications:

　　• B.S. in Chemistry or Biochemistry

　　• 1 years of Scientific experience

　　• Good general biochemistry laboratory skills

　　• Working knowledge of chromatography including HPLC, UPLC, and CE

　　• Working knowledge of compendial methods testing, such as Karl Fischer, Color/Clarity, and UV/VIS spectroscopy

　　• Strong desire to learn and interest in science

　　• Demonstrated proficiency in execution of test methodology following a defined procedure.

　　• Background in chromatography data software (Waters Empower®, Thermo Chromeleon®) and/or automation software (Tecan®)

　　• Understanding of phase-appropriate GMP compliance and documentation

　　• Well-organized; ability to multitask, effectively plan and follow through on complex projects, and to work both independently and in teams

　　Diversity, Equity & Inclusion

　　At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

　　Hiring diverse talent

　　Maintaining an inclusive environment through persistent self-reflection

　　Building a culture of care, engagement, and recognition with clear outcomes

　　Ensuring growth opportunities for our people

　　Actalent is an equal opportunity employer.

　　About Actalent

　　Actalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.