Role Summary
We are seeking an operationally experienced and strategically minded Associate Director to join our Cell Manufacturing team.
Working as part of a team of two Associate Directors, Production, you will provide leadership and oversight across our 7-day manufacturing operations. Together, you will be responsible for the smooth and consistent running of our production activities.
The Production team consists of over 80 team members working across a range of shift patterns to support clinical and commercial manufacturing demands.
This role is accountable for the day-to-day management of operations within the current manufacturing facility, driving the successful scale-up of cell manufacturing capabilities, and preparing the team for expansion into a new commercial facility. In addition, the role plays a key part in the operational implementation of lean manufacturing initiatives and will ensure effective cross-functional collaboration with Quality, MSAT, Engineering, Training, Operational Excellence (OPEX), and Supply Chain teams.
The role is based on-site at the Autolus manufacturing facilities in Stevenage, with occasional travel to London-based sites as required. Please note that this is a shift-based role working Sunday - Thursday, 9AM - 5PM.
Key Responsibilities
* Accountable for day-to-day management of a 7-day cell manufacturing operation across multiple shifts. Expected annual volumes of 2000+ batches in multiple manufacturing suites.
* Accountable for maintaining staff / equipment capacity to support clinical and commercial patient demand, as well as managing risk mitigation when required.
* Accountable for training and development planning for operational staff, providing feedback (and development plans) for all team members.
* Accountable for monitoring of work productivity, reporting on operational trends, and recommend / implement changes to continually improve work productivity and processes.
* Accountable for prioritisation of cell manufacturing lean / continuous improvement initiatives, and implementing new ones as needed.
Demonstrated skills and competencies
E – Essential
P- Preffered
Experience
* Experienced within a similar level position in a manufacturing environment, with over 5+ years management experience
* A strong leader of teams and an inspiring people manager who can lead and motivate a high performing team.
* Data-driven and have an ability to implement improvements after analysing key metrics.
* Project Management and Change Management experience in a large operational team.
* Experience with implementation of MES (or other) computerised systems within an operational environment.
Qualifications
* Degree qualified in a technical field (P)
* Lean Manufacturing / Green Belt (E)
* IOSH (P)
Skills/Specialist knowledge
* Significant experience with manufacturing operations, ideally in a GMP environment (E).
* Strong leadership experience of 24/7 shift operations (E)
* Mastery of Good Manufacturing Practices (E)
* Strong verbal and written communication skills (E)
* Strong demonstrated success on setting team objectives and driving these to completion (E)
* Flexible, self-motivated (E)
* Understanding of cell biology and immunology (P)
* Understanding of and familiarity with regulatory guidance governing pharma / cell-based biopharmaceutical manufacture (E)
* Strong Excel skills, including macros and pivot tables (P)