Senior Manufacturing Manager - 503B Outsourcing Facility

Xseerpharma; Los Angeles (CA); On-site; USD 90,000 - 150,000; Full time

Job summary

Join a forward-thinking company dedicated to producing innovative medications as a Senior Manufacturing Manager. In this pivotal role, you will oversee all aspects of sterile drug production, ensuring the highest standards of safety, quality, and efficiency. Your leadership will drive the implementation of automation processes, enhance operational efficiency, and foster a culture of continuous improvement. With a focus on compliance and excellence, you will play a crucial role in positioning the company as a leader in the industry. If you have a passion for pharmaceutical manufacturing and a commitment to quality, this is the perfect opportunity for you.

Qualifications

• 5+ years in cGMP manufacturing or equivalent experience.
• 5+ years in a managerial role overseeing aseptic operations.

Responsibilities

• Lead sterile drug production including formulation and aseptic filling.
• Implement automation processes to enhance operational efficiency.
• Ensure compliance with cGMP and maintain inspection readiness.

Skills

cGMP compliance

aseptic operations

vial filling operations

Microsoft Office Suite

Education

Bachelor’s degree in a relevant field

Pharmaceutical/Pharmacy field preferred

Tools

manufacturing software

enterprise resource planning systems

electronic Quality Management System

Job description

Senior Manufacturing Manager - 503B Outsourcing Facility

As the Senior of Manufacturing, you will be at the heart of Xseer’s mission to produce innovative medications that help people live healthier and happier. This critical role oversees the entire manufacturing of our 503B Outsourcing Facility, ensuring that we maintain the highest standards of safety, quality, service, and innovation. Your leadership will drive the strategic planning and execution necessary for our facilities and staff to operate effectively and efficiently, positioningXseer as a leader in the industry.

In this hands-on senior role, you will provide visionary leadership for all aspects of sterile drug production, from formulation and aseptic filling to inspection and labeling. Your expertise will be pivotal in overseeing the manufacture of our products, ensuring that we consistently meet production, performance, and quality standards. You will spearhead the implementation of automation in our sterile drug production processes, increasing operational efficiency and advancing our continuous improvement programs.

Duties and Responsibilities

• Provides leadership and direction for all aspects of sterile drug production to include formulation, aseptic filling, inspection, and labeling operations.
• Oversees the manufacture of products, ensuring production, performance, and quality standards are consistently met.
• Implements automation into the sterile drug production process.
• Transfers products into the facility and between manufacturing lines to increase operational efficiency.
• Leads the site’s continuous improvement program with regards to production. Reviews production reports to ensure safety, quality, financial, and delivery goals and standards are met.
• Develops, implements, and monitors day-to-day operational systems and processes to provide visibility into the goals, progress, and obstacles of key initiatives.
• Plans, monitors, and analyzes key metrics for day-to-day operations to ensure efficient and timely completion of tasks.
• Drafts and revises Standard Operating Procedures (SOPs) and work instructions for all operational duties.
• Delivers progress and production reports to Chief Operating Officer as requested.
• Responsible for product inventory levels for the site, ensuring inventory meets company expectations, playing an active role in Sales and Operating Planning through scheduling.
• Walks the production areas daily to review and assure operations are in a state of control.
• Confirms facility is maintained in a constant state of inspection readiness by ensuring staff are compliant with current Good Manufacturing Practices (cGMP) and related elements such as facilities, documentation (SOP, validation protocols, etc.), training, reports, and records.
• Assists with manufacturing software development projects when needed, such as an enterprise resource planning implementation, electronic Quality Management System, etc.
• Creates and implements processes to monitor and minimize waste.
• Leads hiring needs for department and plays an active role in the hiring process.
• Ensures safety throughout operations and identifies preventative action plans to mitigate accidents.
• Ensures manufacturing equipment is operational and in good working order.
• Defines and monitors key performance indicators to evaluate the effectiveness and performance of direct reports. Provides constructive feedback, as necessary.
• Promotes a collaborative work environment and positive company culture.
• Performs other duties as assigned.

Knowledge And Skills

• Demonstrated technical knowledge in title 21 Code of Federal Regulations Parts 210 & 211 compliance for a Food and Drug Administration regulated facility (503B).
• Demonstrated technical knowledge in vial filling operations.
• Demonstrated technical knowledge in aseptic operations.
• Strong proficiency with Microsoft Office (Excel, Word, PowerPoint, Outlook), and productivity software.

Experience and Qualifications

• Bachelor’s degree in a relevant field required, pharmaceutical/pharmacy field preferred.
• Minimum 5 years of experience in cGMP manufacturing or equivalent work experience.
• Minimum 5 years' experience in a manager level position or higher running aseptic manufacturing operations is required.