Career Category

Job Description

Job Summary:

The Aseptic Process Owner role is a Senior role in a newly structured and forming team requiring in-depth technical and operational knowledge of aseptic Drug Product manufacturing processes; Parts/Components Preparation, Formulation, Syringe Filling, Vial Filling and Lyophilisation, Capping.  Supporting key areas of the business, the Aseptic Process Owner will be accountable for Contamination Control processes in addition to responsibilities related to Aseptic Process Simulations.   The Aseptic Process Owner will direct initiatives that improve aseptic processes in addition to day-to-day support related to unplanned event troubleshooting, investigations and implementation of CAPAs.

Primary responsibilities:

• Accountable for Contamination Control and Aseptic Processing Behaviour Programs.
• ADL representative on Aseptic Council and Contamination Control Network.
• Responsible for the Personnel Certification Process and Intervention Risk Assessment(s).
• Supporting manufacturing in delivering supply to patients through Ownership of the assigned processes and taking a proactive approach to safety, quality and compliance by actively seek opportunities to remove error traps.
• Subject Matter Expert with thorough in-depth knowledge of the assigned aseptic end to end processes and interfaces, ensuring audit and inspection readiness and presenting on aseptic processes during facility tours and inspection requests.
• Accountable for process documentation (eg SOPs, Training, Risk Assessments) in assigned area of responsibility.  Gatekeeper (develop, review and update) of process documentation to maintain structure and control over generation and revision ensuring the documents clearly and correctly direct the process. 
• Lead and/or Support investigations that impact on safety, quality and/or compliance of the processes, ensuring thorough investigations are carried out and actionable CAPAs, to prevent future reoccurrence, are identified and implemented within agreed timelines.
• Ownership and project management, within agreed timelines, of CAPAs and Change Controls.
• Utilises subject matter expertise to identify and lead continuous improvement projects in assigned area of responsibility.  Ensuring project timelines are met, challenges identified, mitigations are in place and communication plans delivered to all stakeholders.
• Engaging with staff members within the Manufacturing to ensure understanding of the processes and working collaboratively cross functionally with Facilities & Engineering, Quality, PD and Supply Chain.
• Involved in the daily business management systems and reporting, have a clear understanding of what is happening in the assigned area of responsibility. Monitor any process trends (Personnel and Environmental Monitoring), including business performance metrics. Identify actions that will enable the process and the Manufacturing areas better achieve and surpass metrics in the future.
• Provide input to the shifts on challenges that are encountered. Actively looking at ways to assist in the running of the business and provide support to actions that are related to assigned area of responsibility.
• Provide expertise to Project Teams responsible for the introduction of new products and projects (eg New Vial Filling Line), ensuring successful implementation in the manufacturing area.
• Providing input to strategic initiatives that will improve and develop Manufacturing for the future. The Aseptic Process Owner will then support any projects identified and will be a project manager on some initiatives.

Competencies/Skills:

• Ensures aseptic compliance within cGxP environment.
• Teamwork and ability to coach, mentor and/or cross train colleagues within aseptic operations.
• Problem solving skills: Gathers data from key stakeholders, analyses and interprets information to develop solutions for complex problems.
• Decision Making skills and confidence to challenge others on decisions that impact the manufacturing area.
• Project Management and organisational skills, including ability to follow assignments through to completion.
• Demonstrated ability to work independently and deliver right first-time results under minimal direction.
• Escalate issues professionally and in a timely manner.
• Negotiation and Influence skills.
• Take initiative to identify and drive improvements using lean six sigma tools.
• Excellent verbal and written communication skills: Strong Technical writing skills for cGxP documentation (eg investigations, procedures, change controls) and good Presentation skills.
• Familiar with data analytics.

Education and Relevant Experience:

• Minimally BSc in Microbiology or related discipline.
• 10+ years of biopharmaceutical manufacturing experience in aseptic Drug Product Manufacturing or related cGxP manufacturing experience.
• Experience in Grade A/B Restricted Area Barrier Systems and Isolator Technology.
• Experience with regulatory compliance in cGMP manufacturing and in-depth knowledge of Eudralex Volume 4, Annex 1 Manufacture of Sterile Medicinal Products.