Technical Integrator Analytical Development Job in Beerse, Belgium

Caring for the world, one person at a time... inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.

Our Family of Companies comprises:
The world’s sixth-largest consumer health company
The world’s largest and most diverse medical devices and diagnostics company
The world’s fifth-largest biologics company
And the world’s eighth-largest pharmaceuticals company
We have more than 275 operating companies in more than 60 countries employing nearly 128, 000 people. Our worldwide headquarters is in New Brunswick, New Jersey, USA.

Technical Integrator Analytical Development Job Description

What are the main responsibilities of Technical Integrator:

• Technical Integration group is responsible for developing analytical project development strategies, managing planning and execution of analytical deliverables and coordinating project transfer between phases (early, late development and commercial launch).
• Analytical Technical Integration will require extensive interactions with multidisciplinary and multi-site groups, which may include external vendors and/or strategic suppliers.
• Support Analytical projects within the CMC Organization and will interface with key stakeholders for critical analytical projects for small and large molecules.
• Ensure participation and focused progress of Analytical development groups/projects and other involved CMC functions and facilities.
• Support strategy to meet regional customer requirements in EMEA, Asia Pac and US.
• Develop program development strategy, with respect to analytical technology, clinical and commercial needs, tech transfer, timelines, costs in consultation with the Scientific Director.
• Provide Analytical design, from feasibility to final commercialization. Includes design requirements of analytical methods/specifications to ensure product quality.
• Ensure products, processes, and supporting methods are aligned with strategic technical platforms for analytical methodologies.
• Ensure design alignment with customer needs, early to late development and manufacturing for small molecules and large molecules.
• Core member of development team, with key interactions with API, Drug Product Team Leaders, JSC technical groups, regulatory organizations, quality, & external partners.
• Serve on development teams supporting major and/or minor filings for new products.
• Able to support writing of amendments, annual reports, agency responses, and other submissions.
• Responsible for authoring documents/dossiers as Analytical Technical Integration lead.

Technical Integrator Analytical Development Job Requirements

What does Johnson & Johnson require of a Senior Technician:

• A minimum of 8 years pharmaceutical industry experience. Ph.D. degree is preferred.
• Broad knowledge of the pharmaceutical industry, including in depth operating knowledge of functions involved in analytical within drug development/commercialization process.
• MS Degree in Chemistry, Pharmacy, or equivalent life sciences degree.
• Demonstrated knowledge of analytical or biochemistry in a R&D environment.
• Demonstrated project management and leadership experience.
• Excellent writing and communication skills is a must.
• A proven ability to execute and get results through leading others.
• Ability to foster team productivity and cohesiveness in a complex, matrix environment.
• Excellent interpersonal skills with the ability to adapt effectively to rapidly changing organization issues, structures and dynamics.

Technical Integrator Analytical Development Application Information

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Technical Integrator Analytical Development Summary

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