Manager, Manufacturing

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

Join us as a Manager, Manufacturing!

Join Abeona Therapeutics as a Manager, Manufacturing and be a part of a mission-driven organization devoted to putting patients first. In this role, you will play a crucial part in ensuring that our cutting-edge health care solutions meet the highest quality standards. Collaborate with talented individuals dedicated to transforming lives through innovative therapies.

Abeona Therapeutics Inc.: Who We Are

Our Values: Patient First | Innovation | Integrity | Determination | Trust

Join us in making cure the new standard of care. At Abeona Therapeutics, we exist for our patients and their caregivers; their needs guide our decision-making. We challenge ourselves to think differently, move quickly, and deliver solutions. We hold ourselves to the highest ethical and quality standards. We persevere with resilience and focus to achieve our mission. We build trust through humility, mutual appreciation, openness, and respect.

Your day-to-day as a Manager, Manufacturing

We are seeking a dedicated and experienced Manufacturing Manager to join our exciting and growing team. This role provides direct leadership for Manufacturing personnel and ensures all Manufacturing activities are performed in accordance with approved procedures.

The Manager will be responsible for managing personnel, production schedules and operational readiness. The ideal candidate in this position is well organized, identifies and provides solutions for systemic issues, and provides clear expectations and standards. They will provide strong people leadership focused on personnel development. The Manager must be glove and gown qualified to provide management on the floor in case of conflicts. In addition, this role requires cross-departmental collaboration.

Your expertise will directly impact the quality and reliability of our therapeutic solutions, all while upholding our commitment to putting patients first. This position enables you to contribute meaningfully to the advancement of gene-based therapy solutions in a compliance-focused environment.

Does this sound like you?

To thrive as a Manager, Manufacturing, the right combination of experience, education, skills, and attitude is essential.

This is a front-line management role requiring a background in science, a detail-oriented, quality-first mindset, along with a proven track record in being able to manage, train, and develop junior team members in a GMP compliant setting. Cross-functional collaboration, problem-solving, addressing bottlenecks, and balancing team needs are all a part of the everyday fun and excitement.

If you enjoy both the science behind cell and gene therapy and supporting the people involved in producing these life-changing treatments, this could be a great fit.

Schedule

The initial work schedule will be Monday to Friday from 8:00 a.m. to 4:00 p.m. Once the initial training period is completed, there will be a transition to a 4-day, 10-hour shift schedule (Sun-Wed or Wed-Sat) from 8:00 a.m. to 6:30 p.m. (Workdays and hours may be adjusted to meet patient or company needs on occasion)

Essential Responsibilities and Duties

• Responsible for batch record review and harvest day batch disposition.
• Revising and reviewing SOPs, OJTs, MPRs, protocols, and other documents.
• Coordinate manufacturing activities with Supply Chain, Quality Assurance, Quality Control, Engineering, and Patient Operations.
• Able to identify manufacturing constraints and troubleshoot or escalated issues as needed.
• Must be glove & gown qualified to provide management on the floor during adverse events.
• Responsible for direct reports which include but are not limited to ensuring timely completion of training, personnel scheduling, conducting performance reviews, reviewing and approving timecards in a timely manner, etc.
• Monitor operations to ensure adherence to manufacturing policies and procedures in line with current regulatory guidelines.
• Ensure reports are compliant with all safety requirements and safe work practices.
• Participate in and lead change controls, CAPAs, and quality event investigations.
• Additional duties and responsibilities as assigned.

Required Qualifications

The knowledge and skills required to be successful in the role are:

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

Compensation and Benefits

• The anticipated U.S. base salary range for this position is $90,000–$105,000. Actual compensation will depend on experience, qualifications, and work location.
• Annual discretionary bonus
• Equity opportunities
• Robust health/medical coverage options
• FSA/HSA options
• Company-paid basic dental and vision plans
• Lifestyle spending account (wellness reimbursements)
• 401(k) retirement plan
• Up to 160 hours of paid time off accrual per calendar year (prorated based on date of hire)

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to experience prolonged sitting, some bending, stooping, and stretching. Hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required. A normal range of hearing and vision correctable to 20/20 is required. Occasional work in laboratory, cleanroom, or manufacturing environments may be required. Occasional lifting up to 25 pounds is required. Will require wearing appropriate personal protective equipment (PPE) when entering GMP or lab areas. Occasional walking, standing, or climbing stairs within office or facility settings. Must be able to travel between company sites or to vendor locations, if needed.

Important Notes for Candidates:

Visa Sponsorship Not Currently Available

• Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
• This is a career-path role that is not suitable for someone whose work authorization is temporary and based on optional practical training (OPT).
• Current or future H-1B sponsorship is not available for this role.

Additional Notes to Applicants:

• Due to the volume of applications received, we are unable to respond to every applicant. Only candidates whose qualifications most closely match the requirements of the position and who successfully complete the initial stages of the selection process will be contacted.
• All applications will be reviewed in accordance with applicable federal, state, and local employment laws.

EEOC Disclaimer

We're committed to building a workplace where everyone feels welcome. We are an equal opportunity employer and do not discriminate based on race, color, religion, sex, gender identity or expression, sexual orientation, age, disability, veteran status, or any other protected status.