Biologics Manager

About the Role

This position serves as a working supervisor for the Product Manufacturing Department, overseeing day-to-day operations while ensuring compliance with SOPs, regulatory guidelines, and cGMP standards. The role involves leadership, operational management, quality assurance, and training responsibilities within a regulated blood banking environment.

Responsibilities

• Serve as a working supervisor, ensuring all departmental activities comply with SOPs and regulatory guidelines.
• Supervise, train, coach, and evaluate staff to maintain a high-functioning, compliant team.
• Prepare and manage departmental work schedules and ensure proper coverage.
• Interview and recommend qualified candidates for Product Manufacturing positions.
• Administer the automated time and attendance system for departmental staff.
• Support the development and implementation of annual competency plans; assist with corrective actions as needed.
• Participate in investigations and assist in resolving internal staff concerns.
• Assume full management responsibilities for the Product Manufacturing Department in the absence of the co-manager.
• Ensure staff adherence to all applicable regulatory, quality, and safety standards.
• Manage error-handling processes, including documentation, investigation, and corrective action plans for non-compliance or operational issues.
• Conduct internal audits, ensure timely corrective actions, and maintain audit readiness.
• Maintain and organize training files, documentation, and departmental records for inspection accessibility.
• Oversee the development, review, and maintenance of department SOPs.
• Participate in process improvement projects that enhance safety, compliance, and efficiency.
• Oversee day-to-day component manufacturing, labeling, and storage activities to ensure quality, efficiency, and compliance.
• Ensure accurate completion of production and test result documentation.
• Manage the timely transfer of test results to ensure correct product labeling and disposition.
• Resolve all incomplete or unfinalized test results daily.
• Prepare and submit donor deferral notifications to Quality Assurance.
• Ensure accurate inventory control of blood components and related materials.
• Anticipate hospital and product needs based on inventory reports and coordinate accordingly.
• Assist with preparation and scheduling of periodic maintenance, calibration, and validation of instruments and equipment.
• Write and execute validations prior to implementing new processes, equipment, or software.
• Oversee ongoing training programs for staff related to new and updated processes.
• Ensure annual competency plans are executed and documented for all employees.
• Provide retraining as necessary for performance improvement or regulatory updates.
• Ensure training files, certifications, and competency assessments are maintained in compliance with policy.
• Determine and monitor required sample size for monthly Quality Control (QC) testing.
• Assist with the development, performance, and scheduling of product QC activities.
• Ensure timely product review and release following completion of testing.
• Oversee the resolution of any discrepancies or product holds related to QC.
• Collaborate with QA and laboratory teams to ensure integrity of product data and labeling accuracy.
• Participate in continuing professional development activities.
• Collaborate with other departments to maintain smooth workflow and shared operational goals.
• Maintain confidentiality and security of donor and product information.
• Perform other duties as required to support SunCoast Blood Centers’ mission, vision, and values.

Requirements

Education and Experience

• Bachelor’s degree in Medical Technology, Biology, or related field preferred. Equivalent experience in blood banking or component manufacturing may be considered.
• Minimum of five years of experience in blood banking, component manufacturing, or laboratory operations, with at least two years in a leadership or supervisory role.

Skills and Abilities

• In-depth understanding of FDA, AABB, cGMP, and related regulatory requirements.
• Strong analytical and problem-solving skills.
• Ability to train, mentor, and develop technical staff.
• Excellent written and verbal communication skills.
• Demonstrated ability to manage multiple priorities in a regulated environment.
• Competence in automated systems and laboratory information management systems (LIMS).
• High attention to detail and commitment to quality.

Licenses/Certifications

• Florida Clinical Laboratory License preferred.
• Valid Florida Driver’s License and reliable transportation.

Physical and Environmental Requirements

• Must be able to stand or sit for extended periods of time.
• Occasional lifting of up to 40 pounds.
• Manual dexterity for laboratory and computer-based work.
• Work performed in a laboratory and regulated production environment.
• Exposure to biohazardous materials; appropriate PPE provided and required.

Legal and Regulatory Compliance

• Adhere to all applicable federal, state, and local regulations governing blood banking operations.
• Maintain compliance with FDA, AABB, and cGMP requirements.
• Employment contingent upon successful background check and drug screening in accordance with SunCoast Blood Centers’ Drug-Free Workplace policy.
• Maintain compliance with all organizational policies, including ethics, confidentiality, and code of conduct.