Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office
Job Description
As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
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How will you make an impact?
Manage the Process Engineering team and provides leadership and technical direction and guidance in the areas of manufacturing processes and technology, process improvement, quality performance for commercial batches, assistance in the pre-commercial lots run by Operations and technical support for the execution of Pharmaceutical Development Services (PDS) projects.
What will you do?
- Mentor, guide and coach the department team from a technical perspective to increase level of knowledge and expertise.
- Lead execution of projects for products that are transferring into the site once they have reached scale up, feasibility and the validation stage.
- Attend mid-stage PDS and DPS tech transfer opportunity meetings to ensure that speed and success of implementation is in line with site capabilities and capacity.
- Ensure a smooth and orderly transition of projects from PDS or clients into DPS Operations ensure that batches completed in the Good Manufacturing Practices areas that are to be used for regulatory filings and purposes do satisfy the 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 the 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.
How will you get here?
Education:
College/Technical School diploma in related technical field.
Bachelor's degree in engineering, Science, or related field preferred
Experience:
Minimum 7 years' previous experience in oral solid dose Manufacturing, Quality, Technology Transfer or relevant contract manufacturing cGMP regulated environment.
Minimum 3 years' previous supervisory experience.
Previous project management and/or client experience.
Equivalency:
Equivalent combinations of education, training, and relevant work experience may be considered.
Knowledge, Skills, Abilities:
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.
Standards and Expectations:
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.