Manufacturing Manager, GMP Biotech & Gene Therapy

Abeona Therapeutics Inc.; Cleveland (OH); On-site; USD 90,000 - 105,000; Full time

Benefits offered by this job

Annual discretionary bonus

Equity opportunities

Robust health/medical coverage options

FSA/HSA options

Company-paid basic dental and vision

Job summary

Abeona Therapeutics Inc. is seeking a Manager, Manufacturing to lead Manufacturing personnel and ensure operations comply with approved procedures.

This role partners with cross-functional teams to maintain quality and production readiness for gene-based therapies in a GMP-compliant environment. Ideal candidates have a biology/chemistry/engineering background, 5+ years of regulated manufacturing experience, and proven people leadership.

Qualifications

• Bachelor's degree in biology, chemistry, engineering, pharmaceutical sciences or related field.
• At least 5 years of cGMP pharmaceutical, biotechnology, cell/gene therapy or relevant regulated experience.
• Professional management experience, preferably in the biopharmaceutical industry.
• Excellent communication skills both oral and written, interpersonal skills, and organizational skills.

Responsibilities

• Batch record review and harvest day batch disposition.
• Revise and review SOPs, OJTs, MPRs, protocols, and other documents.
• Coordinate manufacturing activities with Supply Chain, QA, QC, Engineering, and Patient Operations.
• Identify manufacturing constraints and troubleshoot or escalate issues as needed.
• Must be glove & gown qualified to provide management on the floor during adverse events.
• Direct reports: training, scheduling, performance reviews, timecard approvals.
• Monitor operations for adherence to manufacturing policies and regulatory guidelines.
• Ensure reports comply with safety requirements and safe work practices.
• Lead change controls, CAPAs, and quality event investigations.

Skills

Management experience

Communication skills

Interpersonal skills

Organizational skills

Education

Bachelor's degree in biology, chemistry, engineering, pharmaceutical sciences or related field

Job description

Abeona Therapeutics Inc. is seeking a Manager, Manufacturing to lead Manufacturing personnel and ensure operations comply with approved procedures.

This role partners with cross-functional teams to maintain quality and production readiness for gene-based therapies in a GMP-compliant environment. Ideal candidates have a biology/chemistry/engineering background, 5+ years of regulated manufacturing experience, and proven people leadership.