Product Line Lead

Regenity Biosciences; Oakland (NJ); On-site; USD 39,000 - 44,000; Full time

Benefits offered by this job

Performance bonus

401(k) plan

Paid time off

Medical insurance

Tuition Reimbursement

Job summary

Regenity Biosciences in Oakland, NJ, is seeking a Product Line Leader to supervise production of quality medical devices and coordinate manufacturing efforts. You will ensure adherence to batch records, SOPs, cGMPs and safety requirements while supporting process improvements and cost containment.

The role requires strong leadership, ability to transfer processes from R&D to commercial launch, develop validation plans, train staff, and maintain documentation.

Qualifications

• Minimum GED/high school diploma with 4 years in medical device/pharma manufacturing.
• Bachelor degree in engineering or sciences with 2 years related experience.
• Proficient with Microsoft Word, Excel, PowerPoint.

Responsibilities

• Supervise manufacturing team for production of assigned products.
• Oversee transfer of processes from R&D to commercial launch.
• Develop and implement validation protocols and master plans.
• Write and revise Batch Records and SOPs.
• Ensure quality records and GMP documentation.

Skills

Manufacturing leadership

Process improvement

Quality systems

Documentation

Team training

Education

GED/high school diploma

Bachelor’s degree in engineering or sciences

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Job description

The Product Line Leader will be responsible to manufacture, supervise and coordinate production of quality medical devices products that meet acceptance criteria. This position ensures that the solid execution of company programs remain consistent with the overall company values. The ideal candidate has a solid understanding of manufacturing processes and can support the strategic and operational objectives of the business. The successful candidate will possess a high degree of professionalism, maturity and confidentiality.

Essential Job Functions

• Supervise, manufacturing team responsible for production of assigned products.
• Assist in the manufacturing of products in accordance with Batch Records and Standard Operating Procedures (SOPs).
• Ensure quality records, including logbooks, procedures, training records, etc. are completed.
• Implement process improvements with emphasis on quality, safety and cost reduction.
• Monitor and control production costs.
• Oversee the transfer of manufacturing processes from R&D to commercial launch.
• Develop and implement validation protocols and master plans.
• Enforce cGMP's, safety regulations and environmental requirements.
• Ensure assigned personnel are effectively trained in their job requirements.
• Investigate quality issues and prepare investigation reports (CARs).
• Write and revise Batch Records and Standard Operating Procedures (SOPs).
• Prepare and track required GMP documents (ECOs, Process Deviations, Product Dispositions).
• Maintain adequate inventory to prevent backorders and excessive production costs.
• Prepare Annual Product reports and Quarterly trending.
• Initiate action to prevent the occurrence of nonconformities.
• Organize equipment files and meet preventive maintenance and calibration deadlines.
• Maintain supplies and requisition as needed.
• Perform performance management for all assigned personnel
• Interview and select new hires for assigned teams
• Assist with various special ad hoc projects and other duties as assigned

Competencies

Meaningful Innovation

Ownership/Accountability

Pace/Efficiency

Teamwork/Collaboration

Integrity/Ethical Practice

Resilience/Grit

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. While performing the duties of this job, the employee is occasionally required to stand; walk; sit; use hands to finger, handle, or feel objects, tools or controls; reach with hands and arms; climb stairs; talk or hear. The employee must occasionally lift or move office products and supplies, up to 50 pounds.

Supervisory Responsibilities

This position manages manufacturing technicians and assistants staff and projects

Education, Experience and Certification

• This position requires a minimum of a minimum of a GED/high school diploma with four (4) years of medical device or pharmaceutical manufacturing experience or a Bachelor’s degree in engineering or sciences with 2 years medical device or pharmaceutical manufacturing experience
• Experience with Microsoft software applications (Word, Excel, Power Point)
• Ability to perform detailed document review
• Ability to work in a team environment.
• Strong organizational skills ability to simultaneously track multiple projects
• Excellent communication skills (oral and written)

Other Duties as Required

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

Total Rewards & Benefits

Regenity offers a comprehensive rewards package, including:

• Company performance bonus eligibility
• 401(k) plan with company contribution
• Paid time off and paid holidays
• Medical, prescription, dental, and vision insurance
• Companypaid life and AD&D insurance
• Wellness Program and Employee Assistance Program (EAP)
• Tuition Reimbursement

Salary Range: $28-$32 per hour

Regenity Biosciences is an Equal Opportunity Employer. We consider applicants for all positions without regard to race, color, religion, creed, gender, national origin, age, disability, marital or veteran status, sexual orientation, or any other legally protected status. Regenity Biosciences celebrates the diversity of our team and believes that talent, drive, and experience are the only relevant criteria in evaluating new team members.