Supervisor, Production Operations - Nights

Summary

The Production Supervisor supports the timely manufacturing of parenteral products in an aseptic environment according to Current Good Manufacturing Practice (cGMP). Responsibilities include supervising the setup of sterile filling equipment, operating dehydrogenation equipment, managing filling and capping processes, and overseeing formulation tasks. The supervisor ensures compliance with all relevant regulations and procedures, maintains current good documentation practices (cGDP), and participates in training and continuous improvement initiatives. The role also requires supervising the sanitation of aseptic and controlled areas with specialized solutions and equipment, adhering to sanitization protocols for sterile equipment processing, and following Standard Operating Procedures (SOPs).

Essential Duties and Responsibilities

• Manage and coordinate personnel and room activities for assigned shifts
• Compile area-specific shift information and line status data on time, accurately conveying information to support groups and oncoming shift management team
• Ensure compliance with cGMPs, corporate and site-specific policies and procedures
• Maintain and report metrics to evaluate the performance of the assigned production unit
• Mentor, develop, and guide direct reports in succession planning and cross-functional training
• Schedule adherence and material consumption rates relative to specific areas
• Manage operational and preventive maintenance of area-specific processing equipment
• Report and investigate safety incidents and quality deviations
• Become fluent in all functional areas and provide leadership in the absence of manager(s)
• Share resources with other production units as needed and when available
• Lead and/or conduct investigations, document revisions, protocol creation, and CAPA projects
• Read/interpret SOPs to ensure compliance
• Maintain up to date trainings
• Other duties as assigned

Education and Experience

• High school diploma or general education degree (GED), required
• Enrollment in an accredited Associate's or Bachelor's degree program in science, business, engineering, or a related field, preferred
• Minimum of five (5) years' experience in relevant related work in a pharmaceutical manufacturing environment or relevant industry, required
• Minimum of one (1) year leadership experience in a pharmaceutical manufacturing or relevant industry, required
• OR Associate's degree in Science, Business, Engineering, or a related field, with three (3) years of relevant experience in pharmaceutical manufacturing or a related industry, including at least one (1) year in a leadership role, preferred
• OR Bachelor's degree in Science, Business, Engineering, or a related field, with one (1) year of relevant experience in pharmaceutical manufacturing or a related industry, including at least one (1) year in a leadership role, preferred

Supervisory Responsibilities

Responsible for leading and supporting a team to achieve organizational objectives. This role also involves fostering a positive work environment, providing guidance and support to team members, and evaluating performance to drive continuous improvement and achieve both departmental and organizational objectives.

Language Skills

The ideal candidate should have the ability to read and interpret various documents, such as safety instructions, standard operating procedures, technical procedures, and governmental regulations. Additionally, they should possess strong written and verbal communication skills, along with effective presentation skills.

Mathematical Skills

Proficient in executing arithmetic operations including addition, subtraction, multiplication, and division across various units of measurement, employing whole numbers, fractions, decimals, and percentages. Candidates must possess a strong grasp of algebraic and geometric principles.

Reasoning Ability

Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Computer Skills

The ideal candidate will possess a strong technical foundation and proven capability in effectively utilizing diverse software tools to streamline the organization's daily functions. Essential skills encompass adeptness in manufacturing and internet software, alongside proficiency in Microsoft Office tools including PowerPoint, Excel, Word, and Outlook.

Other Skills and Abilities

• Leads with integrity and respect
• Provides guidance, coaching, and mentorship to team members
• Demonstrates business acumen
• Fosters a collaborative and positive work environment
• Champions change
• Coaches and Develops
• Promotes a safe and healthy work environment by actively identifying and addressing potential hazards, following established safety protocols, participating in safety training programs, and fostering a culture of awareness and responsibility among team members
• Demonstrates strong attention to detail

Other Qualifications

• Must pass a background check
• Must pass a drug screen (Must pass random drug screens as well)
• May be required to pass Occupational Health Screening
• Must be able to obtain and maintain gowning certification
• Must be able to obtain and maintain media qualification
• Must be able to wear a respirator
• Must be willing to work nights