Head of Manufacturing

Job purpose:

To deliver an efficient and effective manufacturing operation that is capable of meeting the requirements of 4basebio customers in a manner compliant with relevant regulatory expectations.

Responsible for the scheduling, execution and documentation of 4basebio manufacturing campaigns.

Line management of team members and support activities related to GMP manufacturing operations as per Eudralex and FDA cGMP regulations.

To provide leadership and guidance to the manufacturing team and ensure that all team training and development needs are met.

Responsibilities:

• Preparation of production schedules and management of team workload.
• Line management of manufacturing team members including goal setting, conducting one-to-one meetings, performing employee appraisals and ensuring company polices are correctly followed.
• Ensure that manufacturing operations are run in compliance with regulatory guidelines and that cGMP activities performed in a safe and efficient manner.
• Coordinate and drive training within the manufacturing team to ensure departmental capabilities are appropriate to meet the required quality standards and anticipated future batch requirements.
• Ensure a schedule is in place and maintained for all manufacturing, maintenance and operational purposes and that the schedule in accordance with agreed customer timelines.
• Independently manage and review QMS documentation, keep accurate records, follow instructions and comply with company policies in accordance to GMP regulations and the company QMS.
• As a manufacturing leader, be responsible for key QMS documentation sign off.
• Lead team meetings.
• To help establish and reinforce a high-performance employee-friendly and quality focused work culture.
• Ensure responsibilities are fully understood by staff members through provision of an accurate job description or other suitable documentation.
• Develop, coach and motivate the manufacturing team.
• Manage cleaning, environmental monitoring and housekeeping tasks required to support manufacturing operations.
• Hire new staff as required and manage the onboarding process.
• Keep up to date with relevant scientific, technical and regulatory developments.

Person Specification:

• Significant experience of line management in an operational / manufacturing role.
• Excellent communication, interpersonal and relationship building skills.
• Demonstrated previous success as a people leader.
• Experience of working in a GMP environment in an operational / manufacturing role.
• Commercially astute, pragmatic style.
• Motivated self-starter capable of working both independently and in collaboration with others.
• Strong drive to understand unknowns and comfortable challenging the status quo.
• Ability to translate complex concepts and information into an easy-to-understand manner to external and internal teams.
• Ability to provide a strong, rational and well-supported case for proposed changes and improvements.
• Capable of interaction at all levels of the organisation.
• Bachelor of science degree or equivalent work experience.
• Must have the right to work in the UK.

What we can offer: Competitive salary + private healthcare + pension contributions + life assurance

Location: Over, Cambridge

Due to the high number of applicants, if you do not hear back from us within 6 weeks, we thank you for your interest, but please assume you have not been selected for interview on this occasion.