Director of Aseptic Operations

Job Overview:

Responsibilities:

• Provide leadership to Aseptic Manufacturing Associates of various levels. Responsibilities include hiring, managing, motivating, coaching, and mentoring.
• Ensure oversight of Aseptic Manufacturing operations across all shifts, including weekend support as needed.
• Support implementation of Operational Excellence initiatives 
• Ensure completion of real time batch documentation review from the manufacturing floor 
• Assist with the authoring, revisions and implementation of manufacturing procedures and batch records.
• Lead routine manufacturing activities, including day-to-day scheduling 
• Provide leadership when performing component and equipment preparation, bulk drug formulation, and aseptic filling duties.
• Accurately document data and complete batch records as needed.
• Successfully complete the facility’s gowning and media fill qualification program to provide oversight on the production floor
• Support training by partnering with QA in various manufacturing tasks, including, but not limited to:
• Component Preparation
• Formulation Operations
• Lyophilization Processes
• Product Accountability
• Sterile Filling
• Operate and assist with the maintenance of production equipment partnering with Engineering to ensure
• Perform duties in cleanroom areas and help to maintain those areas.
• Ensure personnel is trained on all applicable procedures and master batch records prior to execution.
• Assist in the scheduling and performance of routine maintenance and calibration of production equipment.
• Participate in client communications, including problem-solving, schedule development, and project status updates.
• Interface with auditors, including client representatives and regulatory agencies.
• Perform Manufacturing review and approval of cGMP documentation in support of continuous improvements, including:
• Procedures
• Master Batch Records
• Standard Work Instructions
• Risk Assessment Reports
• Training Curricula
• Drive a culture that enforces accountability, ownership and supports safety.
• Responsible for ensuring seamless and streamlined shift handoffs with a consistent format and process  
• Drive accountability across Aseptic Managers and/or Supervisors to adhere to procedures and ensure real-time review of batch documentation coming from the production floor, while ensuring a partnership with Manufacturing Quality Assurance to make high quality decisions.
• Responsible for the Operations Board reviewing key metrics including but not limited to EH&S, Quality, and Operations performance daily
• Drive tier discussions with cross functional teams including (but not limited to) EH&S, Quality, Engineering, and Supply Chain reviewing key KPIs.
• Perform other duties as assigned.

Qualifications: 

• Bachelor’s degree in a related field, or equivalent combination of education, training and professional experience that provides the individual with the required knowledge, skills, and abilities.
• Seven (7) years Pharmaceutical and/or Manufacturing Operations Experience.
• Practical work experience in cost and budget control, quality, and operations
• Prior experience interacting with regulatory authorities is preferred.
• Experience in successfully managing complex technical issues using structured analysis and methodology and articulating clear and concise direction to other operations staff. 
• Demonstrate the ability to administer personnel performance evaluations.
• Demonstrate familiarity with Lean/Six Sigma tools and methodologies desired (yellow, green, or black belt)
• Ability to resolve issues pertaining to manufacturing while escalating appropriately and in a timely fashion.
• Effective Conflict Resolution Skills: Using tact and diplomacy to effectively resolve differences and conflicts.
• Self-Motivated: Challenges status quo and sponsors new initiatives acting as a catalyst for change. Generates new ideas and encourages others to do the same. Naturally inquisitive and effectively manages implementation of change.
• Flexible and Adaptable: Effectively manages ambiguity, change and uncertainty.
• Must be able to comprehend and follow all applicable SOPs.
• Demonstrate knowledge and experience with electronic Quality Management Systems such as MasterControl and Trackwise.
• Demonstrate solid understanding of current federal, local, and international regulations regarding the production, testing, and release of drug substances and products.
• Demonstrate a thorough understanding of cGMPs, industry, and regulatory standards and guidelines.
• Demonstrate an intermediate to advanced level usage with Microsoft Office Suite.
• Demonstrate the ability to interpret and relate Quality standards for implementation and review.
• Knowledge of Quality principles and procedures in a pharma, biopharma, and/or biotech manufacturing environment.
• Exhibit professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices.
• Works Independently: Works independently with minimal supervision Displays a strong sense of ownership and accountability for work.
• Ability to communicate the needs and agenda of the manufacturing departments to other groups across the organization.
• Communication: Communicates effectively and professionally verbally and in writing. Good listener who takes care to understand the words of others, asking questions and actively acknowledges key points.
• Action oriented:  Acts decisively in a well-reasoned and professional manner to resolve lack of clarity, structure or definition of outcomes then drives to complete objectives.
• Logical Thinking and Analysis: Assimilates diverse information and proactively presents solutions through detailed analysis. Balances logic and intuition to arrive at well-founded decisions tempered by practicality and common sense.
• Prioritizes and Implements: Identifies issues and opportunities, prioritizes, and successfully implements sound plans and solutions. 
• Customer focused: Maintains internal and external customer focus.
• Goal & Results Oriented: Able to concentrate on the achievement of objectives despite repeated interruptions and distractions. Exercises strong self-control and discipline in pursuit of goals despite conflicting or competing inputs and direction. Focuses on the big picture and employs even, well thought out approaches to solving problems.
• Organized and Timely: Uses effective organization and time management skills. Ensures tasks are completed within set deadlines. Works effectively in a multitask environment and consistently tracks the progress of ongoing initiatives.
• Creative and open-minded who fosters an environment in which sharing of ideas is encouraged.
• Continuous improvement Focus: Continually strives to learn and improve self, reports, and the organization. Sets high standards for work and work relationships. Actively seeks and supports continuous improvement activities in process efficiencies, costs, and effectiveness of work.
• Demonstrate the ability to work closely with a diverse customer and employee base (internal and external).
• Fosters Teamwork/Facilitating: Able to understand the needs and abilities of others in achieving goals, and build an effective team committed to meeting organizational goals and objectives. Encourages team members by using positive reinforcement. Shares recognition and successes with team and fosters collaboration among team members. Is respectful of others and receptive to diverse opinions even when they differ from their own. Can adapt own style to meet unique needs and expectations of others.
• Must communicate fluently in English and have legible handwriting.

Primary Outcomes

• Zero first aid or OSHA recordable incidents 
• Deliver production schedule safely, in line with quality requirements and GMP. OTIF
• Ensure the manufacturing team receives necessary direction, coaching and support to meet departmental goals.

Physical Demands: 

• Ability to travel between and within facilities to visit staff, operations, and projects, as needed.
• Ability to sit, stand, climb stairs, and climb ladders to mezzanines (when necessary).
• Ability to lift up to 40 pounds on occasion.
• Ability to use PPE (safety shoes, goggles, respirators, gloves, etc. when necessary).