Job Title: Site Lead, Biotechnology

Job Description

The Site Lead is responsible for overseeing all aspects of biotechnology product manufacturing and delivery at a designated site. This includes managing production processes, quality assurance, supply chain operations, regulatory compliance, and the integration of technology with manufacturing. The role ensures timely, budget-conscious execution of operations while maintaining high standards of safety, quality, and compliance. The Site Lead also collaborates across functions and with external stakeholders to meet contractual obligations and drive continuous improvement.

Responsibilities

• Lead and manage a cross-functional team including Operations, Quality, and Technology.
• Foster collaboration across departments to ensure alignment with production goals and customer expectations.
• Supervise biotechnology product manufacturing, ensuring adherence to schedules and quality standards.
• Monitor equipment performance and coordinate maintenance.
• Implement lean manufacturing techniques to improve efficiency and product quality.
• Collaborate with Technology teams to ensure processes meet delivery expectations.
• Troubleshoot production issues and resolve bottlenecks in coordination with Product and Sales teams.
• Oversee end-to-end supply chain operations from raw material procurement to product distribution.
• Manage inventory to meet production schedules while minimizing excess stock and optimizing working capital.
• Conduct audits and inspections to ensure compliance with GMP and other regulatory standards.
• Monitor KPIs related to efficiency, quality, timelines, and compliance.
• Ensure adherence to safety protocols and environmental regulations.
• Provide regular updates to leadership on operational performance and challenges.
• Identify and escalate risks related to efficiency, compliance, or product quality.
• Lead crisis management efforts during operational disruptions or safety concerns.

Essential Skills

• Bachelor’s degree in science, engineering, or a related field required.
• 10+ years of relevant experience, including leadership roles.
• Knowledge of microbiology and BSL-2-level pathogen handling.
• Experience with cell culture, cryopreservation, and biotech product testing.
• Proficiency in MS Office and relevant software tools.
• Familiarity with ISO quality systems and GMP practices.
• Strong organizational and communication skills.

Additional Skills & Qualifications

• Advanced degree preferred.
• Preferred certifications: PMP, Six Sigma Black Belt, Lean Manufacturing.

Work Environment

The Baltimore site is primarily a biotechnology manufacturing facility, with work conducted in BSL-2 laboratory conditions, meaning there may be exposure to biohazardous agents but within controlled safety protocols. Benefits include a 10k sign-on bonus, up to 20% yearly bonus, and opportunities for global career growth and development. The company invests in technical, professional, and leadership development, rewarding performance with bonuses, long-service awards, and career advancement opportunities.