Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our distributed team of more than 100,000 colleagues offers an outstanding mix of brand new technologies, convenient purchasing options, and pharmaceutical services across our renowned brands like Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

Location/Division Specific Information:

Phadia is the leading supplier of fully automatic blood analysis systems for allergy and auto-immune diseases. With our innovative products, we set standards worldwide and assist clinicians in providing fast and reliable diagnoses, thus helping patients at an early stage. Phadia GmbH in Freiburg is the German subsidiary of the Immunodiagnostics division of Thermo Fisher Scientific, a global company that develops, manufactures and distributes in vitro diagnostics in the field of allergy and autoimmune diagnostics. Our customers expect a consistently reliable and high standard of quality from our products, which we ensure through innovative biochemical and medical technology solutions as well as highly qualified and motivated employees.

A Day in the Life:

As a Process Manager (m/f/d) you will play a key role in ensuring that all R&D processes within the Autoimmunity division align with relevant laws and regulations. You will develop and refine Standard Operating Procedures (SOPs), enhance existing processes, and ensure alignment within IDD-R&D. Your role will involve regular interaction with internal and external audits and training colleagues on new or updated processes.

Responsibilities:

• Supervise and guarantee that all R&D processes within Autoimmunity follow applicable laws and regulations. Proactively identify deficiencies and spearhead the development and implementation of new processes to close these gaps.
• Direct the creation, ongoing evaluation, and timely updating of Standard Operating Procedures (SOPs), ensuring all documentation is accurate and easily accessible to relevant personnel.
• Lead the alignment of R&D processes across various departments within IDD, ensuring consistency and operational efficiency. Actively facilitate and lead interdepartmental communications to align process goals and strategic objectives.
• Actively participate in and lead initiatives to enhance cross-functional processes involving the Development Department, driving significant improvements and integrations.
• Design and implement comprehensive training programs for both new and revised processes and SOPs. Ensure comprehensive training of all pertinent R&D staff and provide continuous support to maintain strict adherence to these procedures.
• Act as the principal liaison for both internal and external audits concerning R&D processes, robustly defending methodologies and compliance, and offering detailed, well-substantiated justifications for all process decisions.
• Continuously monitor, assess, and enhance the effectiveness of existing R&D processes. Implement industry standard methodologies in process management to significantly boost productivity and operational efficiencies within the department.
• Internal Partners:
• R&D, Production Planning, Marketing, QA/RA, PMO, MSA
• External Partners:
• Notified bodies, Regulatory Agencies (as required for compliance-related issues)

Minimum Requirements/Qualifications:

• Degree in natural sciences (Diplom/MSc), preferably with work experience in the IVD industry.
• Profound experience in R&D or similar high-regulation fields, preferably within IVD industry, with a proven track record in developing, implementing, and improving processes and SOPs.
• Deep understanding of compliance requirements specific to the Autoimmunity and IVD sectors.
• Project Management experience is advantageous
• A proactive attitude with a strong willingness to inspire change.
• Excellent interpersonal and communication skills to effectively interact with all levels of the organization and external partners.
• Proficient in English, both written and spoken. German is a plus.

What we offer:

• Employment with a forward-thinking organization
• Outstanding career and development prospects
• Company pension scheme and other fringe benefits
• Exciting company culture which stands for integrity, intensity, involvement and innovation

If you are interested, please apply online with your CV and Motivation Letter including possible start date and salary expectations.

At Thermo Fisher Scientific, each one of our 100,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

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, disability or any other legally protected status.

Apply today! http://jobs.thermofisher.com

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