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Technical Operations Manager
2 months ago
Thermo Fisher Scientific is seeking a highly skilled Technical Operations Manager to join our team. 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 and guide the department team from a technical perspective to increase their 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 DPStech transfer opportunity meetings to ensure the speed and success of implementation aligns 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 meet 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 regarding 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.
Requirements:
- 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 oral solid dose 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.
What We Offer:
- A dynamic and collaborative work environment.
- Opportunities for professional growth and development.
- A competitive salary and benefits package.
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.
