Senior Scientist, Dose Formulation Expert

1 month ago


Jefferson City, Missouri, United States AmplifyBio Full time
About the Role

AmplifyBio is seeking a highly skilled Senior Scientist or Scientist to join our Dose Formulation and Analysis (DFA) team. As a key member of our team, you will be responsible for the development, optimization, and validation of analytical procedures for dose stability and concentration.

The ideal candidate will have a strong background in analytical chemistry, with experience in HPLC instrumentation and method development. You will work closely with our Study Operations and Quality Assurance teams to ensure that our analytical procedures meet the highest standards of quality and regulatory compliance.

Key Responsibilities:

  • Lead analytical chemistry development projects and collaborate with internal and external clients to develop robust and fit-for-purpose analytical procedures.
  • Qualify and validate new instrumentation for GLP use.
  • Write and collaborate on protocols for analytical procedure development, qualification/validation, and technology transfer.
  • Perform routine and non-routine analytical testing methods using Agilent HPLCs with OpenLab Data Acquisition Software.
  • Set the example for colleagues to work in accordance with guidelines and requirements established by FDA Good Laboratory Practices (cGLP), Good Documentation Practices (cGDP), Code of Federal Regulations (CFR), and other applicable regulatory guidance.

Requirements:

  • Masters degree in chemistry, biochemistry, or related field of study with minimum 10 years of experience in a related field.
  • Doctoral Degree with a minimum 4 years of experience in a chemistry laboratory operation or analytical development role in a regulated laboratory operation.
  • Experience and knowledge in an analytical chemistry laboratory with in-depth knowledge of HPLC instrumentation for GLP use, including method development, assay qualification/validation, technology transfer, and troubleshooting using DAD/FLD/ELSD/MSD.
  • Ability to maintain rigor and high quality of execution and documentation required by GLP and other regulatory agencies.
  • Ability to work in a fast-paced environment and flexible.

What We Offer:

  • Competitive compensation package.
  • Flexible PTO policy.
  • Generous paid parental leave.
  • Wellness and self-care programs.
  • 401(k) match.
  • Tuition reimbursement.
  • EAP/work-life support system.
  • A fun work environment where everyone's voice matters.
  • An opportunity to change the world.

About AmplifyBio:

AmplifyBio is a leading contract research organization with a comprehensive range of services that span from being an outsourcing partner for discovery stage R&D work, a preclinical CRO performing safety efficacy and toxicology studies for small molecules and advanced therapies alike, and, most recently, an expansion into manufacturing services for cell, gene, and mRNA-based therapeutics.

We take the health and happiness of our employees seriously and consistently evaluate new ways to Amp up our benefits to provide an amazing place to work.



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