Distinguished Scientist, Autoinjector Platform Full-time

Distinguished Scientist Position

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.

Primary Responsibilities

Technical Strategic Oversight:

• 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. Additionally, coach and mentor others to grow their technical rigor to lead and/or contribute to investigations and resolutions.

Cross-Functional Collaboration:

• 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. Key collaborative and influential partnerships span across multiple stakeholders and organizations within our Research and Development (R&D) and Manufacturing divisions.
• Interface with external suppliers and partners to ensure the quality and compliance of components used in Autoinjectors, driving performance, accountability, and innovation.

Lifecycle Management and Technical Transfer:

• Oversee lifecycle support for Autoinjector products, including performance monitoring, design optimization, and process validation. Additionally, coach and mentor others to grow their technical rigor to lead and/or contribute to lifecycle management.
• 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.

Regulatory Compliance:

• 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.
• Ensure that all engineering activities adhere to relevant regulatory standards and industry best practices. Additionally, coach and mentor others to grow their technical rigor to lead and/or contribute to regulatory submissions and audits.

Innovation and Continuous Improvement:

• Stay abreast of industry trends, emerging technologies, and best practices in Autoinjector technology, providing and championing recommendations for continuous improvement and innovation.
• Champion initiatives for design enhancements and supply chain expansions, ensuring that components meet their intended use and performance qualifications against industry standards.
• Encourage the exploration of problem solving in innovative ways to achieve technical and business results. Personally drive and model technical rigor in expectations and actions.

Mentorship and Development:

• Provide mentorship, coaching, and guidance to junior engineers and cross-functional teams, fostering a culture of technical excellence and innovation.
• In partnership with senior leadership, enable the growth and technical, scientific, and operational strength of the talent pipeline.
• Promote knowledge sharing, technical excellence, and best practices within the organization, ensuring that technical expertise is disseminated effectively. Inspire a learning culture and drive deep technical understanding.

Minimum Education Requirements – One of the following:

• 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.

Required Experience and Skills:

Technical Knowledge:

• In-depth understanding of Autoinjector design, manufacturing processes, and regulatory requirements.
• Familiarity with materials science, particularly as it relates to drug delivery systems, including knowledge of damage mechanisms, common defects, and performance testing.

Regulatory Compliance:

• Strong knowledge of relevant regulatory requirements such as ISO, USP, FDA guidelines, and other global regulatory standards pertaining to medical devices and combination products.
• Proven track record of successful technical leadership and problem-solving in a regulated environment.

Communication and Collaboration:

• Excellent communication, interpersonal, and collaboration skills to effectively engage with cross-functional teams, external suppliers, and industry partners.
• Ability to influence and drive consensus among diverse stakeholders.

Leadership Competencies:

• Strategic Planning: Develop long-term strategies that align with organizational goals and drive measurable technical and business results.
• Decision Making: Strong analytical skills to evaluate complex technical issues and make informed and decisive decisions.
• Emotional Intelligence: Build trust and foster relationships across scientifically/technically diverse disciplines, teams, and organizations. Promote and role model collaborative and transparent ways of working. Adjust communication approaches during interacting with teams, stakeholders, and governance committees.
• Innovation: Encourage experimentation and the development of novel solutions to enhance product performance and customer satisfaction.
• Enterprise Mindset: Embrace an enterprise and robustness at launch mindset, making disciplined decisions for the good of the business.
• Networking and Partnerships: Cultivate internal and external strategic relationships across the industry to drive the advancement of understanding scientific/technical issues to achieve business goals.
• Influence: Create and execute strategies to gain commitment to ideas that ignite actions to advance shared interests and business goals across stakeholders. Able to influence without formal authority; ability to influence and present ideas to senior leadership.
• Motivation and Inspiration: Propels self and others toward higher levels of performance that are aligned with the organization's purpose and goals.

The salary range for this role is $206,200.00 – $324,600.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include 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. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance.

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.

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