POSITION: Director of Lab Operations

RESPONSIBLE TO: Chief Operations Officer

JOB SUMMARY: The Director of Laboratory Operations is a critical leadership role responsible for overseeing the strategic and daily operational aspects of the allergen immunotherapy laboratory. This includes ensuring compliance with regulatory standards, driving operational efficiency, achieving financial goals, and maintaining the highest levels of accuracy and safety in the preparation of patient immunotherapy treatment. The Director is responsible to bring a strategic vision to enhance laboratory services, optimize patient outcomes, and lead our team towards excellence in extract formulation.

RESPONSIBILITIES INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING:

• Operational Leadership: Oversee the laboratory's daily operations, ensuring all activities align with regulatory standards (including USP797) and organizational goals. Drive the laboratory’s financial performance by optimizing processes and resources.
• Quality and Compliance: Maintain a rigorous quality control program to ensure all laboratory activities meet or exceed regulatory and safety standards, focusing on precision and patient safety. Actively monitor and improve laboratory compliance with OSHA, CLIA, and other relevant regulations.
• Team Management: Lead, motivate, and develop a high-performing team. This includes hiring, training, and evaluating staff performance to build a cohesive and skilled team dedicated to excellence in immunotherapy formulation and lab operations.
• Strategic Planning: Develop and implement strategies to enhance laboratory services, improve efficiency, and reduce costs. Collaborate with senior management to align laboratory goals with organizational objectives.
• Stakeholder Relations: Serve as the primary liaison between the extract laboratory and our internal team, including physicians, external partners, and suppliers. Ensure effective communication and problem resolution for all operational issues.
• Innovation and Improvement: Foster a culture of continuous improvement and innovation within the laboratory. Stay abreast of industry trends and advancements in extract and immunology to implement best practices and cutting-edge technologies. As the company grows, the position is expected to identify opportunities for expansion. Travel is expected to new and existing sites to ensure operational excellence is replicated across all locations.

OTHER

• Completes all assigned AP training (such as CPR, OSHA, HIPAA, Compliance, Information Security, others) within designated timeframes.
• Complies with Allergy Partners and respective hub/department policies and reports incidents of policy violations to a Supervisor/Manager/Director, Department of Compliance & Privacy or via the AP EthicsPoint hotline.
• Models the AP Code of Conduct and demonstrates a commitment to the AP Compliance Program, standards and policies.

SUPERVISORY RESPONSIBILITIES

This job has supervisory responsibilities which typically involve managing a staff of nursing, laboratory, and other clinical personnel.

TYPICAL PHYSICAL DEMANDS

Position requires prolonged sitting, some bending, stooping, and stretching. Good eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, and other office equipment is also required. Employee must have normal range of hearing and eyesight to record, prepare, and communicate appropriately. Normal healthcare office/lab environment. Occasional evening or weekend work. This role may involve up to 30% travel to assist in the setup, training, and operational management of additional locations within the network, ensuring consistency and quality across the organization.

EDUCATIONAL REQUIREMENTS:

• Bachelor's degree in nursing, pharmacy or related clinical field preferred.

QUALIFICATIONS AND EXPERIENCE:

• Minimum of 5 years of experience in a clinical laboratory setting, with at least 3 years in a managerial or supervisory role, preferably in a clinical laboratory or pharmacy setting. Prior experience with allergen extract formulation and preparation is optional but desired.
• Demonstrated ability to drive operational excellence and financial results.
• Extensive knowledge of laboratory regulations, standards, and quality control practices.
• Understanding of OSHA, CLIA and other applicable guidelines for healthcare practices
• Proven leadership skills with the ability to manage and develop a team.
• Strong organizational, analytical, and decision-making skills.
• Excellent communication and interpersonal abilities, with the capability to engage effectively at all levels of the organization, physicians and with external partners.
• Adaptability and flexibility to address issues and challenges as they arise.