Biologics Manager

ESSENTIAL JOB FUNCTIONS Leadership and Supervision Serve as a working supervisor for the Product Manufacturing Department, ensuring all 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.

Compliance and Quality Assurance 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.

Operational Management Oversee day-to-day component manufacturing, labeling, and storage activities to ensure quality, efficiency, and compliance with cGMP standards.

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.

Training and Competency 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.

Quality Control and Product Release 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.

Professional and Organizational Support 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 Sun Coast Blood Centers’ mission, vision, and values.

PHYSICAL AND ENVIRONMENTAL REQUIREMENTS

Physical 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.

Environmental Requirements:

Work performed in a laboratory and regulated production environment.

Exposure to biohazardous materials; appropriate PPE provided and required.

LEGAL AND REGULATORY REQUIREMENTSAdhere 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 Sun Coast Blood Centers’ Drug-Free Workplace policy.

Maint…