Issue resolution

Able to raise, report and resolve issues in a timely manner and effectively. Also able to proactively identify impending problems and ensure preventative steps are taken, including escalation to higher management as required.

Customer focus

Strong customer focus, responsible for delivery to meet customer requirements on time and to expectations.

Collaboration

Strong collaboration culture ensuring effective working within manufacturing and cross functionally. Able to handle instances of conflict resolution both internally in the department and also interdepartmentally.

Negotiation

Strong negotiation ability in managing team, customer and stakeholder expectations.

Influence

Strong influencing ability in managing team, customer and stakeholder expectations.

Functional responsibilities

People

Line management responsibilities.

Budget

Act to keep costs (wastage) at a minimum.

Quality

Ensure that department KPI’s are at an acceptable level.

Safety

Ensure that safety is embedded in new process / projects introduced.

Job Description

• Act as Subject Matter Expert (SME) for manufacturing activities, covering upstream and downstream processes.
• Leadership of cleanroom activities including scheduling and batch readiness.
• Support routine GMP manufacturing activities as required.
• Assist in organisation of projects as required.
• Responsible for driving GMP documentation updates including BMRs, SOPs and forms.
• Overview of root cause investigation activities and solutions.
• Support Senior managers in new process introduction and resource management for batch execution and for completion of required batch readiness documentation.
• Leadership of root cause investigation activities and ownership of resulting CAPA projects.
• Responsible for personal and direct reports timely completion of quality records.
• Line management of Senior Manufacturing Scientists, Manufacturing Specialists and Manufacturing Officers and responsible for ensuring staff are trained and training records are up to date.
• Setting of Objectives/PDP/End of Year Reviews for Direct Reports.
• Oversee and implement change in manufacturing including new processes/equipment and changes in Quality/GMP Procedures as directed by senior managers.
• Ensure staff work in a safe manner, and ensure staff awareness of all EH&S policies and procedures.

Experience, knowledge and skills

Essential

• BSc or MSc in Degree in Biological Sciences, Biotechnology, Bioprocessing or related discipline.
• 6 years or more experience in GMP environment.
• Demonstrated track record in leading teams (e.g. matrix management).
• Sound knowledge in viral vector manufacturing.
• Sound knowledge in both upstream and downstream processing.
• Knowledge of regulatory guidelines and compliance to ICH/FDA/EMA/MHRA in relation to Viral Vector/GMP Manufacture.
• Strong communication and interpersonal skills, capable of representing function in engagement with key stakeholders.
• Demonstrated track record of delivery in fast-paced manufacturing environment to meet schedule requirements and high quality expectations.
• Creative problem solver.
• IT skills including Word, Excel and Project or other Project Management tools.

Desirable

• Experience of working in a CDMO environment.
• Experience in inspection / audit participation.
• Experience with equipment and process validation.
• Experience in Quality by Design.
• Experience with data management and use of statistical tools.

This job description has been developed based upon the expected and current duties, responsibilities and requirements for the position. Job requirements evolve with the changing needs of the company, this job description is subject to change and may be modified in line with business requirements.