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Technical Operations Manager
2 months ago
We are seeking a highly skilled Technical Operations Manager to join our team at Thermo Fisher Scientific. As a key member of our operations team, you will be responsible for leading the Process Engineering team and providing technical direction and guidance in the areas of manufacturing processes and technology, process improvement, and quality performance.
Key Responsibilities- Mentor, guide, and coach the department team from a technical perspective to increase the level of knowledge and expertise.
- Lead the execution of projects for products that are transferring into the site once they have reached scale-up, feasibility, and validation stages.
- Attend mid-stage Pharmaceutical Development Services (PDS) and Drug Product Services (DPS) transfer opportunity meetings to ensure that the speed and success of implementation are in line with site capabilities and capacity.
- Ensure a smooth and orderly transition of projects from PDS or clients into DPS Operations, ensuring that batches completed in the Good Manufacturing Practices areas satisfy regulatory needs.
- Collaborate with and advise Director/Sr Manager Operations and operations staff on product process issues and troubleshooting.
- Review PDS and commercial batch records for containment, safety, and accuracy of process.
- Develop proposed process trains for new products potentially entering the commercial plant.
- Provide scientific and technical input directly or via staff to the quality organization to support conclusions and resolutions with regards to deviations, investigations, audits, complaints, and Corrective Action Preventative Actions (CAPA) etc.
- Provide technical assistance with 24-hour shift coverage for the execution of trial, feasibility, or pre-commercial batches run by Operations.
- Track quality performance trends and keep CAPA actions on track.
- Schedule and manage day-to-day activities in the department as well as prepare and circulate departmental activity reports and schedules, including team metrics.
- Develop, propose, and help implement continuous improvement plans for capacity, processes, and technologies.
- Lead client interactions during validation observation visits.
- Support site on new business initiatives through client visits and proposal generation.
- Promote a safe working environment, report potential hazards, and ensure all direct reports follow Environmental Health and Safety procedures.
- Select, develop, and evaluate staff to ensure the efficient operation of the function. Work with and advise staff on administrative policies and procedures. Recommend changes in staffing and budgets as needed. Staff may include internal and third parties.
- College/Technical School diploma in a related technical field.
- Bachelor's degree in engineering, Science, or a related field preferred.
- Minimum 7 years' previous experience in Manufacturing, Quality, Technology Transfer, or a relevant contract manufacturing cGMP regulated environment.
- Minimum 3 years' previous supervisory experience.
- Previous project management and/or client experience.
- Equivalent combinations of education, training, and relevant work experience may be considered.
- Strong knowledge and understanding of manufacturing/operational processes.
- Excellent knowledge of Good Manufacturing Practices and Food and Drug Administration (FDA) compliance knowledge.
- Strong interpersonal and communication skills (both oral and written).
- The ability to motivate and influence.
- Ability to meet deadlines and prioritize multiple project deliverables.
- Comfortable dealing with all levels in the organization as well as directly with clients.
- Demonstrated computer proficiency with Microsoft Office programs.
- Proficiency with the English language.
- Follow all Environmental Health & Safety Policies and Procedures.
- Work collaboratively with fellow team members, modelling positive team principles and partnering to meet project and departmental objectives.
- Carry out all duties within strict compliance to quality systems SOP's and Good Manufacturing Practice (GMP).
- Maintain workspace in a clean and orderly fashion.
- Actively engage in and adhere to departmental systems in order to maintain a smooth and efficient workflow (visual management, scheduling systems, etc.).
- Be client and patient conscious at all times.
- Understand Key Performance Indicators and strive to improve the performance of the team by identifying areas for system improvements and engage in problem-solving.
- Models positive thinking and is open to change, motivating the team to adapt to shifts in priorities and new ways of working.
- Proactively identify areas for improvement in the execution of procedures.
- Communicate risks to timelines in a proactive manner.
- Consistently strives to improve skills and knowledge in related field.
