Senior Bioassay Associate

Overview

Execute and manage analytical method lifecycle for gene therapy products in a GMP setting.

Key Responsibilities

• stability testing
• method transfer
• assay development
• data trending
• regulatory reporting
• root cause

Tasks

-Support routine and investigational stability testing protocols, ensuring timely and accurate data generation. -Train and mentor junior QC analysts to ensure consistent execution of analytical procedures and lifecycle activities. -Collaborate with internal and external stakeholders to ensure phase-appropriate testing, data trending, and technical reporting aligned with regulatory expectations. -Develop and execute analytical method lifecycle activities such as method transfers, qualifications, validations, and stability testing. -Engage in method lifecycle projects involving ddPCR, qPCR, nucleic acid purification/extraction, cell-based potency assays, and sub-visible particle analysis. -Create and maintain technical documents, including protocols, SOPs, and reports to support regulatory and operational compliance. -Conduct root cause analysis for OOS/OOT investigations, contributing to continuous improvement and CAPA implementation.

Requirements

• bioassay
• method validation
• gmp
• cell culture
• elisa
• hplc

What You Bring

-Proficient in bioassay and method validation. -5 years of previous pharmaceutical experience with GMP. -Experience in transferring methods and ensuring their validation. -Experience with method transfer, cell culture, ELISA, ddPCR, and HPLC.

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Benefits

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

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