Senior Manager of 503B Production

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Description

Corporate Statement

Nephron Outsourcing Facility is a 503B outsourcing facility dedicated to creating the highest quality compounds by maintaining current good manufacturing practices to and above the standards set by the FDA.

Position Summary: Director of 503B Outsourcing Operations

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.

Primary Accountabilities

• Regulatory Compliance
• 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.
• Production Management
• 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.
• Team Leadership
• Manage, train, and mentor production staff, fostering a culture of continuous improvement and accountability.
• Conduct performance evaluations and implement develop 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.
• Quality Assurance
• 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 accordingly to regulatory requirements.
• Process Improvement
• 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.
• Safety and Environmental Compliance
• 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.
• Budget Management
• 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
• Stakeholder Communication
• 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.
• Technology Integration
• 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.
  
  

Knowledge, Skills & Abilities

NOTE: The primary accountabilities and knowledge, skills and abilities are intended to describe the general content of and requirements of this position and are not intended to be an exhaustive statement of duties. Incumbents may perform all or most of the primary accountabilities listed below. Specific tasks or responsibilities will be documented in the incumbents’ performance objectives as outlined by the incumbents’ immediate supervisor or manager.

• 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.
• Incumbents are required to wear PPE as assigned by management.
• Incumbents are required to comply with proper gowning requirements and other non-specified protective equipment as necessary.
• May involve standing or walking for extended periods.
• Ability to lift and carry up to 50 pounds occasionally.
• Incumbents may be required to wear safety glasses, hearing protection, bouffant, and laboratory coats and other non-specified protective equipment as necessary.
• Salary range: Based on experience.
• Flexible base on product demand.
  
  

EEO Statement

Nephron is an equal employment opportunity employer and does not discriminate against employees or job applicants on the basis of race, religion, color, sex, sexual orientation, gender identity, age, national origin, disability, status as a protected veteran, pregnancy, marital status, genetic information, childbirth, medical needs arising from pregnancy and childbirth and related medical conditions, including lactation, or any other consideration made unlawful by applicable federal, state or local law.

Nephron Pharmaceuticals is a drug free workplace.