Job title: Chief Operating Officer

Reports to: CEO

Supervises: Production Supervisor, QC Manager, QA Manager, Engineering Manager, Facilities Manager, Warehouse Manager

We are looking for a highly motivated Chief Operating Officer (COO). This exciting and challenging role reports to the CEO and is responsible for planning and execution for the company’s production, chemistry and engineering operations in FDA-registered facility. The COO has the authority and responsibility for corporate-wide leadership of manufacturing quality control, quality assurance, and engineering and facilities related activities. We are looking for a talented leader who will oversee the day-to-day operational activities.

This full- time on site employee will oversee management of operations including production, engineering, quality assurance, quality control, and facilities. This person will actively participate and manage the operating plans for the company.

Duties/Responsibilities

• Directs the development of manufacturing projects, chemistry projects and engineering projects
• Executes the operational corporate strategic plan and meets or exceeds all operational KPI’s in a timely manner.
• Implements new projects, equipment, and programs
• Identifies and implements process improvement opportunities and/or corrective actions to increase yield, maximize capacity, improve operational efficiency, reduce costs, and ensure safety while maintaining regulatory compliance in all operational areas.
• Monitors and maintains efficient flow of materials and documentation through the warehouse, manufacturing process, chemistry testing and quality review. Identifies and eliminates bottlenecks, and ensures production batches are available when needed.
• Supervises and supports quality initiatives and acts as Operations representative for regulatory interactions including FDA
• Collaborates with the Quality team to ensure all areas maintain optimal state of cGMP compliance including housekeeping/cleanliness, adherence to SOP’s, documentation accuracy and product and chemistry quality standards.
• Ensures timely responses to closure of cGMP matters defined by Quality, including Material Reviews, CAPA, deviations, documentation errors, etc.
• Collaborates with Engineering to identify opportunities for efficiency gains in areas such as processes, equipment, planning and cleaning, and implements improvements effectively.
• Develops and improves departmental and equipment SOP’s and policies as necessary, and ensures staff is properly trained on all SOP’s and regulatory documents. Monitors procedural compliance so that processes are executed consistently in an accurate manner.
• Collaborates with R&D scale up and implements new products and reformulations to achieve timely launches.
• Ensures processes are staffed to meet departmental requirements as well as departmental budgets.
• Ensures all departments and employees achieve relevant goals
• Oversees multiple departments comprised of exempt and non-exempt workforces to translate the company’s strategic plans and objectives into tactical and functional plans to drive resource deployment
• Partners with marketing/sales team to set schedules and timelines for product delivery
• Fosters an environment of continuous improvement in the areas of cost, quality, service and manufacturing best practices
• Ensures that employee related tasks are completed timely including time/attendance, performance reviews, corrective action, and training.
• Encourages and enforces a culture of Safety, and Quality as required by cGMPs, OSHA, government agencies, and company standards / policies.
• Supports all site audits and inspections.
• Follows all Aurora Pharmaceutical policies, procedures, regulations and employee handbook
• Assumes additional responsibilities as requested.

Education and Experience

• B.S degree in Operations Management, Engineering or Chemistry
• 10+ years relevant experience in pharmaceutical industry and cGMP environments
• 5+ years Multi-team management experience; prior roles in leading and managing teams and projects

Required Skills/Abilities

• Self- starter and a team player who will thrive in an entrepreneurial and fast paced environment
• Demonstrated experience working cross-functionally and collaboratively with R&D, QA, QC, Engineering and Maintenance teams
• Excellent organizational skills to achieve multiple high priority responsibilities
• Proven leader with the skill to lead and motivate teams to achieve consistent levels of success
• Strong verbal and written communication skills
• Analytical problem-solving skills with an impeccable attention to detail
• Ability to see the “big picture” while being capable of driving detailed, tactical execution.
• Proven business acumen with bottom-line orientation.

Job title: Production Technician

Supervisor: Production Manager

Position Purpose:  Manufactures pharmaceutical products according to SOPs, GMP and batch record specifications. Performs the day to day activities of the production process including weighing, blending, filling and packaging products.  Collaborates with other production staff and other departments.

Job Responsibilities

(Essential job functions noted *

• Works all areas of production operation: weighing, blending, filling, packaging, cleaning*
  • Accurately weighs product*
  • Blends product according to batch record and SOP*
  • Accurately fills and packages materials*
  • Cleans equipment and rooms to specifications*
• Regularly inspects equipment for proper functioning*
• Meets productivity and production schedules and deadlines.*
• Troubleshoots process/production problems.*
• Assists with inventory duties such as receiving, product retrieval and shipping.
• Safely operates forklift*
• Complies with established standard operating procedures, cGMP quality standards and regulatory procedures*
• Accurately and consistently completes and documents batch records and other required paperwork*
• Precisely follows work orders and specifications*
• Adheres to all plant safety policies and procedures*
• Assists in set up, change over and test runs of equipment for various sized batches and various products
• Effectively communicates with other production employees and with all levels of management*
• Promotes a positive can-do attitude*
• Collaborates in cross functional teams*
• Consistently follows all company policies & procedures. *
• Performs other duties as requested
• Meets the following physical requirements:*

Sits, bends, stands, walks 90% of the time*

Repeatedly lifts or pushes a cart with 35-80 lbs*

Able to pass a respirator health test

Willing to wear required PPE

Qualifications – Education and Experience

• 1+ years experience in pharmaceutical or food manufacturing in compliance with 21CFR Part 211–Current Good Manufacturing Practice *
• Must be willing to work first or second shift and weekends if needed. *
• Flexible and open minded to suggestions from others; keen vision for continuous improvement.*

This job description is subject to change at the sole discretion of Aurora Pharmaceutical, LLC.

Job title: Lab Analyst

Supervisor: Quality Control Supervisor

Duties:

• Performs routine sampling, analysis and documentation of pharmaceutical samples – raw materials, intermediates, drug products, package materials*
• Accurately weighs samples and prepares volumetric solutions*
• Performs analytical tests: titration, conductivity, pH, residuals on ignition, specific gravity, loss on drying, etc.*
• Generates experimental data according to written SOP, protocol, method, or work instructions*
• Follows guidelines when recording data*
• Accurately calculates and reports results*
• Accurately maintains laboratory data and logs*
• Maintains, calibrates and cleans laboratory equipment*
• Cleans glass ware*
• Accurately labels samples and chemicals*
• Collaborates in cross-functional teams*
• Follows all Aurora Pharmaceutical policies, procedures, regulations and the employee handbook.*
• Follows designated work schedule.*
• Assumes additional responsibilities as requested.*
• Accepts and acts upon supervisory directions.*
• Supports supervisor’s role.*
• Demonstrates flexibility, i.e. willingly takes on new tasks.*

(* denotes essential job functions)

Knowledge, Skills & Abilities:

• Prefer candidates with interest and background in pharmaceutical testing, sampling and regulations
• Basic knowledge of analytical chemistry and laboratory concepts and techniques
• Basic knowledge of computer applications

Education:

• Bachelor’s in Science related field preferred
• Will consider: Associates in Chemistry and 2 years experience in lab setting.