Manufacturing Area Manager
Job ID : 92841BRLocation : United Kingdom - Swindon : Job DescriptionWhen you’re part of Thermo Fisher Scientific, you’ll do challenging work, and be part of a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of more than $20 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.At our site in Swindon, ThermoFisher are forging partnerships that are transforming the industry, creating new business models between pharma companies and their pharma service providers. We are pioneering solutions that are driven by client needs, with successful recent partnerships including Flexion and Pacira.We currently offer solutions spanning the entire pharmaceutical life cycle to help pharma and biotech companies of all sizes meet their complex development and manufacturing needs at any stage or scale enabling us to deliver a combination of unrivaled quality, reliability and compliance, backed by a reputation for scientific and technical excellence.The range of services at ThermoFisher for drug substances and drug products is wider than that of any other CDMO and we offer end-to-end capabilities and expertise to take your discovery from pre-clinical and clinical development, through scale-up, all the way to commercial supply across more than 40 oral solid, sterile and softgel dosage forms.Key Accountabilities The Operations Manager will lead a complex pharmaceutical drug product formulation and filling team to ensure commercial demand is met at all times. Primary responsibilities for this position are to manage the production of drug product with consistent performance both on the formulation and filling lines. The position will require a high degree of technical, business and people management acumen. The person filling this role should comfortably use effective leadership and communication skills to engage the operations team and the larger business unit support staff to maintain a high level of drive and professional working standard.You will work alongside the Technical Transfer, Quality Assurance, Maintenance, and Validation departments to ensure business and client requirements are met and in compliance with cGMP. It is imperative that the department delivers only products of the highest quality to our customers. In addition, the operations manager should continuously work to improve the process performance using Lean manufacturing techniques and maintain a positive working environment for the staff.As Operations Manager will develop and implement manufacturing strategies to meet commercial demand during an expansion of the manufacturing and filling suites. This person will be responsible for interpreting internal and external commercial and project challenges to identify solutions to maintain consistent and efficient commercial operation. The position will oversee significant resource and production spend, close monitoring of budget and overtime spend will be required.Other Duties: Optimize performance outcomes of direct reports ensuring individual's understanding of contribution. Acts as role model for Thermo Fisher Scientific leadership and sets the standard to follow.Ensure Manufacturing oversight and support to all steps of the batch manufacturing process and all supporting processes, e.g.: Cleaning, bulk manufacturing, filling, Requalification and Utilities. Perform routine GEMBA safety and quality walks at regular frequency and own action resolution.Ensure cross-functional scheduling and cooperation in the generation of all documentation related to the batch manufacturing process. Ensure supporting processes are executed, reviewed and approved in compliant and timely manner e.g. Batch Records, Deviations, CAPAs, Change Controls, Logbooks, Validation/Qualification protocols and reportsEnsure that the operation team Quality Metrics and Key Performance Indicators are effectively monitored and completed in accordance with timelinesEnsure supervision on the Shop floor to Maintain a high level of compliance with safety and quality regulationsCooperate closely with QA, engineering, calibration, validation etc. ensuring proactive approach to identify potential issues and minimise impact on manufacturing scheduleIdentify and support Practical Process Improvement initiatives to eliminate or/and reduce waste and non-value adding activities within the Business UnitManagement of the “BU Ops team” and all aspects of the people process including, hiring, on-boarding, mentoring, coaching, performance management and employee developmentEnsure appropriate staff training and personal development plan are in place and implemented to assure competency (suitably qualified and experienced personnel) and support operations and continued improvement initiativesInspire and lead the team to meet corporate goalsSupport and encourage a “Quality Culture” throughout the BUResponsible for ensuring own training is current and compliant and own PDP is current and actionedEnsure Performance Development Plans are in place for all team members, including both job technical knowledge and pharmaceutical knowledge development.Support associated areas when the business requiresTrack and monitor downtime in the area, implement strategies to reduce downtimeSupport and guide TL’s in labour allocation to support manufacturing, PPI, Kaizen Projects etc. (suitably qualified and experienced).Qualifications/ExperienceThermo Fisher is looking for candidates who are curious, driven and have excellent communication and presentation skills. A science, engineering or related technical background is recommended. Prior management experience is required, ideally in pharmaceutical or other regulated industry.Experience of medium to large scale pharmaceutical manufacturing or similarly regulated field, desirable powder manufacturing knowledgePreferably qualified to degree level in Science, Business or Engineering or equivalents.Working knowledge of the principles and guidelines for GMP as set out in the ‘Orange Guide.Experienced in managing and leading through to drive continuous improvements.