Operations Manager

Hobson Prior are currently recruiting for an Operations Manager to join a clinical-stage biotechnology organisation who have an ambitious vision to create better lives for people suffering from chronic systemic diseases.

Please note that to be considered for this role you must have the right to work in this location.

Job Responsibilities:

• Work closely with the Head of Production in the planning and practical delivery of development and clinical product supply for the products.
• Work closely with the Head of Production to develop quality systems and operational procedures within Production to establish and operate the facility in compliance with cGMP and necessary licenses, delivering Production Metrics and ensuring prompt completion of compliance actions across Production
• Manage the Operations Planning Manager, delivering the production schedule (scheduling engineering, non-clinical and clinical batches of drug substance), maintenance schedule and annual facility shutdowns to GMP standards.
• Lead the interaction with the Manufacturing Centre team to ensure an integrated and aligned operating model is delivered. This includes scheduling activities in the facility including material / waste transfer, equipment transfer, equipment maintenance, qualification activities.
• Team lead for safety in both internally representing the Production and safety forum to ensure procedures and practices are in place.
• Ensure safety of staff and compliance procedures and external standards for safety and environmental protection.
• Managing equipment servicing and maintenance based on equipment qualification and validation, liaising with procurement / external suppliers / contractors, ensuring completion of RAMs, inductions to site and review / completion and approval of servicing / maintenance documentation.
• Review and approve production records prior to quality review.
• Ensure production records are completed to principles of ALCOA+.
• Responsible for departmental PQS training documentation, training matrix, production staff's training files and auditing for compliance.
• Recruit, mentor and develop the production team in GMP compliance and ensure quality systems are in place.
• Onboard new team members, coordinating training, and site inductions.
• Any other assigned duties.

Key Skills:

• Experience leading cross-functional teams.
• Demonstrates strong analytical and problem-solving skills.
• Excellent verbal and written communication and computer literacy skills.
• Strong project planning skills with familiarity with MS project and typical Project Management tools.

Requirements:

• Educated to degree level or equivalent in chemistry or a biological science.
• Operations experience preferably in a manufacturing setting with experience of development of systems and processes to enable both team operation and facility operation.
• Strong understanding of Quality systems and operating within a Quality environment, following ICH Q10 principles and a risk management approach.
• Experience of working in a continuous improvement environment / implementing lean methodologies.
• Proven track record in project management for biotech / pharma development.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.