Manufacturing Manager

Manufacturing Managers with a background in Solid Dose Pharmaceuticals I want to speak to you about a very exciting opportunity to join a client who are looking to expand and streamline their manufacturing facility.

This role has the responsibility to lead and manage the manufacturing operation and to co-ordinate production resources, at their Production facility in Hatfield.

• Organise the manufacturing operation for the reliable, efficient and compliant production of pharmaceutical products.
• Responsible for the establishment of appropriate procedures and systems, for the routine operation of all manufacturing activities.
• Define and owns manufacturing’s key production performance indicators and implement corrective, preventative or continuous improvement activities to address any adverse trends.
• Responsible for recruitment, training and management of a manufacturing workforce.

To ensure that operations conducted are performed in accordance with the requirements of Corporate Standards, Quality System, GMP and GDP Guidelines, Industry Standards & support the Continuous Improvement process.

Duties are performed to ensure:

• A safe working environment is maintained for self and other Eisai employees, ensuring all near miss incidents and accidents are reported in accordance with procedures.
• The Quality of products manufactured and released is assured through adherence to all procedures.
• Opportunities to improve operations and reduce cost are identified and progressed through the continuous improvement and demand innovation initiatives.
• The companies philosophy of hhc is at the forefront of daily activities.
• All stakeholder and customer expectations are understood and met through communication.
• Performance is in line with personal and Eisai objectives with demonstrated behaviors and competencies.

This position has working relationships with the following:

• Manufacturing operators to lead, manage and coordinate the operation.
• Production planning to ensure smooth planning of the operation.
• Production management to manage the whole operation cohesively.
• Supply chain to build a longer term plan for the year and to understand the 5 year forecast and plan strategically.
• Finance to ensure the manufacturing operation remains within budget and profitable.
• Engineering to ensure maintenance and corrective activity is planned, managed and resourced.
• Technical to support new production introduction, life cycle management, improvement and corrective activity for the manufacturing operation.
• Quality Operations to ensure the manufacturing operation remains complaint.
• Warehouse to ensure a strong link between areas.

Details of responsibilities:

• Ensuring the manufacturing operation is fully resourced to cover the planned volume, including the recruitment staff.
• Ensuring the training of the manufacturing operators is fit for purpose, the operators are trained in activities ensuring sufficient trained resource is available to meet business demands throughout the year, training is planned and completed proactively.
• Leadership, management, motivation, development and coaching of Manufacturing staff to meet business needs and objectives.
• Ensure objectives are set for the manufacturing operation for the year for each member of staff aligned to EMLs objectives, the volume for the year and the coming years direction.
• Responsible for ensuring manufacturing’s key performance indicators are defined, fit for purpose, owned, understood and acted upon, to keep the manufacturing operation safe, complaint and profitable.
• Responsible for ensuring the manufacturing operations remains safe via attending management EHS training, ensuring risk assessments are in place for manufacturing operations and periodic reviews are covered, ensuring risk assessments and mitigations are in place as required for changes to the manufacturing process or facility, conducting or delegating EHS audits of the area and building a continuous improvement culture including using the near miss process.
• Works with Production Management team to lead production as a whole.
• Represent production in internal, customer and regulatory audits and inspections.
• Identify, facilitate and implement continuous improvement opportunities that result in cost savings and more efficient and compliant ways of working.
• Co-ordinate the production cleaners to maintain a clean facility working with local facilities management.
• Co-ordinate and participate in the installation, qualification and validation of any new manufacturing equipment.
• Co-ordinate and participate in the development and validation of any new or changes to manufacturing processes.
• Organise manufacturing overtime requirements.
• As required organise and chair Production Planning Meetings.
• Conduct Production tours to internal and external visitors.
• Ensure regular audits are in place of manufacturing tooling / equipment store areas and routine review of log books and other records.
• Work with production administrator to purchase consumable items and production equipment.
• Liaise with Planning and Engineering to ensure manufacturing machine maintenance is completed on time.
• Liaise with Planning to develop and maintain production schedules and with other departments to ensure business requirements are met.
• Investigate / acknowledge EMS alarms and conduct EMS alarm testing.
• Minimise manufacturing down time to maximise productivity, by managing various priorities and proactive mitigation of risk resulting in the effective co-ordination of manufacturing resources.
• Prepared to take on roles of First Aider, Safety Rep and Fire Warden.
• Act as manufacturing first point of contact for any SAP or DMS issues working with EIT and other internal/external partners to investigate & resolve these issues in a timely manner.
• Conduct Production Reviews of Completed Manufacturing Batch Records and prepare/issue Manufacturing Batch Records to the production floor.
• Ensure production facility documentation is in place, current and compliant. Production documentation includes but is not limited to SOPs, MBRs, Production Forms, Log Books, Balance Verifications Records and Purified Water Cleaning Records.
• Conduct and/or correctly resource investigations into any deviation, incident or customer complaint and ensure CAPAs are completed on Trackwise in a timely manner.
• Sponsor or complete assessments of change controls impacting manufacturing.
• Participates in development of departmental budget and controls expenditure within this.
• Support the Production Manager in the development of long term strategic capital and headcount plans for the Production function.
• Support and input into the EML 5 year plan, to ensure objectives are in place to keep the manufacturing operation fit for purpose.
• Identifies resource to support and inputs into EML projects.
• To provide support and cover to the Packaging Shift Managers.
• Act as a delegate for the Production Manager.

Performs any other responsibilities at the request of the Production Manager.

• Significant experience in the pharmaceutical industry in an operational environment, including proven ability and achievements in a significant supervisory role.
• Good technical writing skills.
• Computer literate (MS Office suite) and ideally knowledge of the SAP system.
• Demonstrable familiarity of MHRA guidance for packaging and manufacturing operation, cGMP and H&S regulations.

• Demonstrated ability to lead, manage and motivate others
• Problem solving strengths
• Decision making capabilities
• Professional behavior and self-awareness
• Listens well to fully understand, demonstrates empathy, champions Equity, Diversity & Inclusion.
• Excellent Communicator, can adapt styles for differing target audiences
• Able to lead and work effectively within a Team
• Effective time management, self-starter Self motivating