Senior Manager of 503B Production

About the position

The Senior Manager of 503B Production will oversee the entire production process within the 503B outsourcing facility. This role is responsible for ensuring compliance with FDA regulations, maintaining high-quality standards, and managing production staff to meet organizational goals. The ideal candidate will have a strong background in pharmaceutical manufacturing, with specific experience in 503B compounding.

Responsibilities

• Ensure all production activities comply with FDA 503B guidelines and other regulatory requirements.
• Develop and maintain Standard Operating Procedures (SOPs) and ensure staff adherence.
• Liaise with regulatory bodies and represent the organization during inspections and audits.
• Oversee day-to-day production operations, ensuring efficient and timely production of compounded sterile preparations.
• Monitor production schedules to meet customer demands and organizational goals.
• Implement and maintain quality assurance processes to ensure product safety and efficacy.
• Coordinate with supply chain management to ensure the availability of raw materials and components needed for operations and demand.
• Manage, train, and mentor production staff, fostering a culture of continuous improvement and accountability.
• Conduct performance evaluations and implement development plans for team members.
• Ensure adequate staffing levels and manage recruitment for the production team.
• Foster a collaborative environment between production, quality assurance, sterility, environmental monitoring, and R&D teams.
• Collaborate with Quality Assurance team to implement quality control measures and address any deviations or non-conformities.
• Participate in internal and external audits and inspections, ensuring readiness and compliance.
• Ensure all documentation related to production processes is accurate, complete, and maintained according to regulatory requirements.
• Identify opportunities for process optimization and efficiency improvements.
• Lead initiatives to enhance production capabilities and reduce operational costs.
• Implement and monitor key performance indicators (KPIs) to measure and improve production performance.
• Drive continuous improvement projects using Lean Manufacturing and Six Sigma methodologies.
• Ensure a safe working environment by enforcing safety protocols and conducting regular safety training.
• Oversee the proper handling and disposal of hazardous materials in compliance with environmental regulations.
• Conduct regular risk assessments and implement corrective actions to mitigate safety hazards.
• Develop and manage the production department's budget, including labor, materials, and capital expenditures.
• Monitor expenses and implement cost-saving measures without compromising quality or safety.
• Prepare regular financial and operational reports for senior management.
• Act as a key point of contact for internal and external stakeholders, including suppliers and regulatory bodies.
• Provide regular updates to senior management on production performance, challenges, and opportunities.
• Collaborate with sales and marketing teams to align production capabilities with market demand.
• Evaluate and implement new technologies and equipment to enhance production efficiency and product quality.
• Ensure all production equipment is properly maintained and calibrated.
• Stay current with industry trends and advancements to maintain a competitive edge.

Requirements

• Bachelor’s Degree in Pharmacy, Chemistry, Engineering, or related field preferred.
• Minimum of at least 5 years’ experience in Pharmaceutical Manufacturing.
• Must have necessary licensing per position requirements.
• In depth knowledge of FDA regulations, cGMP, and other relevant guidelines.
• Strong leadership and team management skills.
• Willingness to participate in training and gain other certifications as needed.
• Computer experience: Microsoft office software.
• Experience with Lean Manufacturing and Six Sigma Methodologies.
• Project Management Certification preferred.
• Proven track record of successfully leading production teams in a regulated environment.
• Experience with advanced manufacturing technologies and manufacturing.
• MUST PASS DRUG TEST.
• MUST BE A TEAM PLAYER.
• Must speak, write, and read English.
• The ability to manage a multitude of resources and to be organized, accurate, and current with data and information.

Nice-to-haves

• Experience with advanced manufacturing technologies and manufacturing.

Benefits

• Flexible salary based on experience and product demand.