Distinguished Scientist, Autoinjector Platform

Merck KGaA Darmstadt Germany-posted 4 months ago

$206,200 - $324,600/Yr

Full-time • Senior

Onsite • Rahway, NJ

Chemical Manufacturing

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We are seeking a highly experienced and skilled Distinguished Scientist to join our Device Development & Technology (DD&T) organization to serve as a senior technical subject matter-expert and advisor for our Autoinjector platform. This role's scope and accountability will encompass the entire lifecycle from early development through lifecycle management, providing critical technical strategic oversight and guidance across all teams involved in the development and support of Autoinjectors. The ideal candidate will possess extensive knowledge in medical device engineering, particularly in the design, manufacturing, and regulatory aspects of Autoinjectors and combination products.

Provide deep subject matter expertise in the design, development, and manufacturing of Autoinjectors, ensuring compliance with industry standards and regulatory requirements (e.g., ISO 13485, FDA regulations).
Actively seek out, anticipate, and solve significant scientific and technical challenges.
Lead complex investigations into technical challenges related to design, manufacturing, and scale-up processes, employing advanced material science principles to resolve issues effectively.
Coach and mentor others to grow their technical rigor to lead and/or contribute to investigations and resolutions.
Act as the primary technical advisor for all teams working on Autoinjectors, fostering collaboration among engineering, quality assurance, regulatory, and manufacturing teams across the CMC ecosystem.
Interface with external suppliers and partners to ensure the quality and compliance of components used in Autoinjectors, driving performance, accountability, and innovation.
Oversee lifecycle support for Autoinjector products, including performance monitoring, design optimization, and process validation.
Manage a broad scope of technical transfer activities related to the introduction of new Autoinjector products from development to manufacturing, ensuring robust introduction, qualification, and performance monitoring.
Collaborate closely with R&D and Manufacturing regulatory teams to ensure compliance with applicable regulations and standards, preparing and reviewing technical documentation for regulatory submissions and audits.
Stay abreast of industry trends, emerging technologies, and best practices in Autoinjector technology, providing and championing recommendations for continuous improvement and innovation.
Provide mentorship, coaching, and guidance to junior engineers and cross-functional teams, fostering a culture of technical excellence and innovation.

BS/BA degree in Biomedical Engineering, Mechanical Engineering, Materials Science, or related disciplines, with a minimum of 20 years of hands-on experience in medical device engineering, with a focus on Autoinjectors or combination products.
MS/MA degree in Biomedical Engineering, Mechanical Engineering, Materials Science, or related disciplines, with a minimum of 18 years of hands-on experience in medical device engineering, with a focus on Autoinjectors or combination products.
PhD degree in Biomedical Engineering, Mechanical Engineering, Materials Science, or related disciplines, with a minimum of 15 years of hands-on experience in medical device engineering, with a focus on Autoinjectors or combination products.
In-depth understanding of Autoinjector design, manufacturing processes, and regulatory requirements.
Strong knowledge of relevant regulatory requirements such as ISO, USP, FDA guidelines, and other global regulatory standards pertaining to medical devices and combination products.
Excellent communication, interpersonal, and collaboration skills to effectively engage with cross-functional teams, external suppliers, and industry partners.
Strong analytical skills to evaluate complex technical issues and make informed and decisive decisions.

Experience in mentoring staff and promoting knowledge sharing within the organization.
Ability to influence and drive consensus among diverse stakeholders.
Experience in strategic planning and decision making in a technical environment.
Familiarity with materials science, particularly as it relates to drug delivery systems.

Medical, dental, vision healthcare and other insurance benefits (for employee and family).
Retirement benefits, including 401(k).
Paid holidays, vacation, and compassionate and sick days.
Annual bonus and long-term incentive eligibility.

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