Bioassay Team Lead

2 weeks ago

Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

About the Job

As a seasoned professional, you will take on the role of Manager in QC Bioassay, overseeing a team of both Scientists and Technicians. Your primary objective is to create a positive and inspiring work environment, leading by example and fostering a culture of excellence.

The successful candidate will report directly to the Director of QC Bioassay and be part of the Bioassay Leadership team, where collaboration and support are integral to daily operations. You will work closely with other departments within QC and across the organization, driving results-oriented initiatives.

Key Responsibilities:

  • Lead Team Development: Provide strategic guidance and drive the growth of your team, ensuring they have the necessary tools and resources to excel.
  • Task Prioritization and Direction: Set clear priorities, motivate the team, and allocate tasks effectively to ensure seamless execution.
  • QC Coordinator Activities and Training: Participate in training programs, interact with customers, and contribute to the development of QC Coordinator activities.
  • Reference Material Strategy: Establish a comprehensive strategy for Reference Materials, ensuring their timely availability and quality.
  • Control Material Supply Chain: Develop and maintain a reliable supply chain for Critical reagents, guaranteeing timely readiness and minimizing disruptions.
  • QC Deliveries and Batch Release: Oversee QC deliveries, ensuring compliance and adherence to regulatory requirements.
  • Customer Audits and Regulatory Inspections: Collaborate with cross-functional teams to prepare for customer audits and regulatory inspections.
  • QC Bioassay Compliance: Ensure that QC Bioassay operates in full compliance with regulatory standards.
  • Release and Stability Testing: Support Managers from other QC Bioassay teams in release and stability testing, promoting seamless collaboration.
  • Continuous Improvement: Drive continuous improvement initiatives, focusing on process optimization and the adoption of new technologies.

About You

We are seeking an exceptional individual with a strong background in life sciences and extensive experience within the pharmaceutical industry. Your expertise should include analytical development or Quality Control, with a proven track record as a leader, preferably in a GMP environment.

  • Leadership Experience: Proven leadership experience, preferably in pharmaceuticals, biotech, or related fields.
  • GMP Mindset: A strong GMP mindset and experience working in a GMP environment.
  • Communication Skills: Excellent communication skills, with a service-minded attitude and ability to build relationships with stakeholders across the organization.
  • Bioassay Methods Knowledge: In-depth knowledge of Bioassay methods.
  • Reference Materials Control: Familiarity with controlling reference materials.
  • Fast-Paced Environment: Ability to navigate a fast-paced environment, juggling deadlines and tasks with finesse.
  • Adaptability: Flexibility to adapt to evolving business needs and priorities.
  • Continuous Improvement: Interest in continuous improvement and process optimization, with a focus on new technologies and automation.

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