Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Loud Noises (Equipment/Machinery), Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description
Are you ready to take the next step in your career in pharmaceutical manufacturing? We have an exciting opportunity for Operations Manager as part of our sterile pharmaceutical manufacturing team at Swindon. This is an opportunity where someone can make a real difference working at the heart of operations on site. This could be an ideal role for someone to expand upon their current manufacturing and leadership experience and join us a complex, dynamic and continuously improving pharmaceutical manufacturing environment!
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Business Job Title: Operations Manager
Job Profile Title (Internal title): Manager Operations
Reports to: Senior Manger Operations
Group/ Division: PSG
Career Band: Band 07
Career Track: Management
Position Location: Swindon
Number of Direct Reports: 8 (40 indirect)
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are driving progress in life sciences research, taking on complex analytical challenges, enhancing patient diagnostics and therapies, or optimizing operations in their laboratories, we are here to provide them with our support. Our global team of more than 100,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com
Role Summary:
This role is for an Operations Manager for bulking and filling of commercial sterile pharmaceutical products in compliance with company quality regulations, and external regulatory expectations and delivering On Time, In Full (OTIF) to customers with a Right First Time (RFT) approach. An essential part of the role will involve developing, inspiring, and leading productions teams, supporting continuous improvement and contributing to the overall performance of the site. This role works in close collaboration with Quality Assurance, Technical Support, Engineering, Supply Chain, Technical Transfer, Quality Control and Business Management.
Leadership/ People Management: Support development of team members and ensure their understanding of individual contribution. Act as role model for leadership capabilities, safety and quality compliance.
- Lead, manage and develop team members using regular informal feedback, 121s and performance management and development programme considering technical, pharmaceutical, financial and business aspects.
- Ensure manufacturing plans are detailed and aligned to meet delivery targets, identifying and coordinating resolution activities as required
- Review manufacturing downtime trends, determine solutions and implement strategies to reduce downtime
- Drive operations related projects for completion on time and in budget
- Deputize for Senior Operations Manager if required.
- Represent the organisational values in discussions with colleagues, clients, auditors and inspectors.
GMP/ Compliance and Ethical Conduct: Ensure compliance of self and others to standards and regulations through working in alignment with processes and procedures
- Prioritise and supervise allocation of workload associated with quality records
- Coordinate, write and review deviation investigations utilising root cause analysis tools to enable effective and robust Corrective Actions/Preventative Actions to prevent recurrence
- Identify staff training and development needs
- Conduct self-inspections and maintain a state of audit readiness within operations
Lean & Continuous Improvement: Proactively look for opportunities to drive continuous improvement (Practical Process Improvement), influence decisions and deliver the results
- Work with site leadership team to develop metrics and identify appropriate targets.
- Cascade and communicate to the teams through the varied communication channels (visual managment boards, handovers, tiered accountability huddles, 121s, team meetings, PMDs) to support a strong understanding of targets, and foster a desire to achieve and exceed. Trend and report team performance to targets.
- Develop tools for strategic improvements within operations and supervise progress against metrics by implementing Practical Process Improvement (perform Gembas of processes, contribute to Kaizens and Root Cause Counter Measure workshops, complete Just Do It actions, collaborate with other departments on cross-functional projects)
- Role model and champion 5S and lean manufacturing principles
Safety, Health & Environment: Promote an environment of safety and wellbeing of self, others and environment.
- Understand and ensure implementation of emergency procedures and safe systems of work.
- Ensure compliance with environment, health and safety rules, signage and instructions
- Ensure prompt reporting and investigation of all accidents, near misses and identified hazards
Qualifications/Experience:
- Experience of bulk manufacturing and filling within medium to large scale pharmaceutical manufacturing.
- Deep understanding of regulations surrounding Good Manufacturing Practice across UK, Europe and USA, preferably with experience of manufacturing sterile drug and implementation of UK/EU GMP Annex I
- 5 years leadership experience in a Pharmaceutical/Healthcare environment (preferably within manufacturing, quality, or engineering).
- Preferably qualified to degree level in Science or Engineering (or a related field).
- Proven track record of making sound risk-based decisions in line with internal and external quality standards
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Accessibility/disability access
Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.
- This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.