By joining Bio-Techne, you’ll join a company with a powerful and positive purpose of enabling cutting-edge research in Life Sciences and Clinical Diagnostics. Bio-Techne, and all of its brands, provides tools for researchers to further treat and prevent disease worldwide.

Reports To: Director, Small Molecules Business Unit. Dotted reporting line into corporate operations

Location: Bristol

Hours of Work: Full time (37.5 hours per week)

Position Summary

The Senior Manager, GMP Operations will have overall responsibility for GMP chemistry manufacturing at the Bio-Techne Bristol site and will ensure the smooth running of operations in our dedicated GMP manufacturing facility. They will lead and coach a team of GMP Production Operatives and facility support employees, ensuring compliance with relevant GMP and quality guidelines. They will develop production plans and maintain manufacturing schedules in close collaboration with other departments (Operations, Quality, GMP Development Chemistry) to ensure facility utilization is maximized and customer and business requirements are consistently met.

Essential Duties & Responsibilities

Operational

• Accountable for GMP manufacturing and ensuring compliance with applicable guidelines.

• Responsible for all GMP facility operations, including scheduling in line with the product / manufacturing pipeline, to ensure maximum facility utilization and delivery to meet customer demand.

• Responsible for ensuring relevant H&S regulatory requirements are adhered to and that employee and facility safety are not compromised.

• Participation in audits performed by Regulatory Authorities and Customers.

• Responsible for ensuring customer requirements are met or exceeded with a clear customer focus.

• Close collaboration with other departments, particularly Quality, Operations, Facilities and GMP Development Chemistry.

• Ensure alignment and co-ordination with GMP Development Chemistry to ensure smooth transition of processes from development through to manufacturing.

• Close working relationship with corporate Operations to ensure global alignment and visibility. This may require occasional travel to our US headquarters.

• Collection and presentation of KPI data to site and corporate leadership. Use of data to assess areas that require improvement, then lead implementation of improvement projects and efficiency gains.

• Point of contact for technical issues in the manufacturing process.

• Direct responsibility over non-conformance investigations and root cause determination. Ownership of CAPAs implementation.

Leadership and Technical Expertise

• Work closely with the Quality team to ensure understanding of current requirements relevant to ancillary material manufacture for ATMPs, whilst keeping abreast of regulatory developments, making recommendations as appropriate to ensure compliance.

• Contribute to site leadership as the subject matter expert for GMP, providing guidance and insight to guide strategy.

• Work collaboratively with other GMP-related groups across Bio-Techne to ensure alignment of processes and sharing of best practices, and support any collaborative projects as required.

• Responsible for the people management of the Bio-Techne Bristol GMP Production Operatives and Facility Support employees, from recruitment and onboarding, to performance review and management, and supporting any exits.

• To lead, manage and motivate the team to deliver their goals and objectives in relation to the company vision and strategy.

• Ongoing development of the team through regular 1:1s, training, coaching and mentoring, as appropriate.

• Perform any additional duties as required that are commensurate with this role.

Minimum Requirements/Qualifications

• Qualified to degree level in chemistry or chemical engineering, PhD preferred

• >5 years’ experience leading and developing teams in a GMP chemical manufacturing environment. A good understanding of the safety risks associated with running a manufacturing facility and actions that are required to minimise them.

• Expert knowledge of Quality Management Systems such as ISO 9001:2015.

• Expert knowledge of GMP requirements such as EudraLex Volume 4 Part 2.

• Understanding/experience in ATMP manufacturing (desirable).

• A highly skilled people manager with experience of matrix management.

• Knowledge of process and facilities validation.

• Knowledge of process utilities and clean room functionality.

• Knowledge of risk process analysis tools including but not limited to FMEA and Ishikawa.

• Knowledge and exposure to Process Safety Management (PSM).

• Knowledge of aseptic processing.

Personal Qualities and attributes

• Excellent attention to detail, time management, project management, problem solving and organizational skills

• Excellent ‘can do’ attitude.

• Ability to perform a wide variety of tasks and multi-task efficiently

• Ability to remain calm under pressure

• Ability to build strong relationships cross functionally

• Ability to make effective decisions and execute an appropriate course of action which complies with quality and regulatory requirements while supporting business objectives.

• Excellent verbal and written communication skills with the ability to establish effective collaborative and operational relationships with cross-functional teams in Bio-Techne, and with external contacts and customers as appropriate.

• Able to work to deadlines in a positive, flexible and proactive manner.

• An approachable, confident and supportive manager.

• Self-motivated, can work independently, lead, and influence others.

• Ability to display consistent leadership behaviours in line with the Bio-Techne culture.

• Ability to wear appropriate PPE required to work in clean room environments.

Bio-Techne is committed to product quality, customer satisfaction, continued improvement, minimising environmental impacts and conserving natural resources. Environmental and quality management is an integral core value and vital part of the Bio-Techne culture.