Laboratory Operations Director - Biologics

Overview

Leads Biologics lab operations, strategy, client relations, and technical services.

Key Responsibilities

• analytical services
• method development
• mass spectrometry
• capacity planning
• regulatory compliance
• client liaison

Tasks

-Develop and implement growth strategies to expand biologics capabilities, revenue, and market share. -Attract, develop, and retain high-performing team members through effective selection, training, and performance management. -Drive operational efficiency, technical advancements, and laboratory innovation. -Stay current on industry and regulatory laboratory trends, adapting quality systems and practices as necessary. -Lead capacity planning, resource allocation, and prioritization of biologics projects. -Oversee analytical services for biologics, including bioassays, bioseparations, and mass spectrometry characterization. -Ensure adherence to SOPs, training, and other regulatory requirements. -Promote professional development, technical training, and succession planning for staff. -Foster a culture of quality, compliance, scientific excellence, and continuous improvement. -Partner with Business Development to support client presentations, proposals, and scientific discussions. -Ensure projects are executed on time, within budget, and to the highest quality standards. -Provide overall direction and leadership for biologics programs in Bioseparations, Mass Spectrometry, and related teams, ensuring alignment with company strategy and client expectations. -Serve as a subject matter expert in Biologics for internal and external stakeholders. -Provide technical and regulatory expertise for biologics method establishment and testing strategies. -Translate client needs into actionable project plans while balancing scientific rigor with business requirements. -Develop and report metrics and key performance indicators to monitor laboratory compliance and performance. -Formulate and implement policies that meet compliance and operational expectations. -Act as the primary point of contact for key biologics clients, ensuring exceptional customer service and responsiveness. -Promote a collaborative and innovative environment that encourages problem-solving and accountability.

Requirements

• mass spectrometry
• biochemistry
• hplc
• capillary electrophoresis
• 12+ years
• leadership

What You Bring

-Deep hands-on experience with mass spectrometry for biologics characterization. -Bachelor, Master, or Doctorate degree in Biochemistry or a related science field; advanced degree preferred. -Strong command of HPLC techniques (e.g., SEC, RP-HPLC, IEX) for purity, potency, and stability testing. -Experience with capillary electrophoresis for charge variant analysis and glycan profiling. -12+ years of pharmaceutical laboratory experience with 6+ years in leadership roles.

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Benefits

-Medical, dental, and vision insurance -Competitive salary.

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