Director Drug Product CMC (mRNA LNP, Drug Development)

At Aldevron we shape the future of medicine by advancing science in meaningful ways. Our team of dedicated forward-thinking associates share this goal by combining best-in-class products and service with the ideal operating environment to lay the groundwork for vital new discoveries worldwide. We believe people are our most valuable asset. Whether this is your first step on a rewarding career path or are a seasoned professional ready to take your career to the next level we hire the best from all backgrounds and experiences.

Aldevron is one of 10 Life Sciences companies of Danaher. Together we accelerate the discovery development and delivery of solutions that safeguard and improve human health.

We are seeking a strategic and technically accomplishedDirector of Drug Product CMCto lead client-facing drug product development and manufacturing programs within our CDMO. This role is critical in driving the design development and execution of robust CMC strategies for a diverse portfolio of clients spanning early-phase to commercial-stage programs. The ideal candidate will bring deep technical expertise strong project leadership and a collaborative mindset to deliver high-quality solutions in a fast-paced client-centric environment.

This position is part of the mRNA CDMO located in Fargo ND and will be remote. At Aldevron we combine best-in-class products and servicewith the ideal operating environment to lay the groundworkfor vital new discoveries worldwide. You will be a part of the mRNA CDMO and report to the VP/GM mRNA CDMO responsible for mRNA sequence to vial mRNA services. A key responsibility will be to implement drug product strategy across all departments ensuring alignment with overall company goals and objectives.

Responsibilities:

• Serve as the primary CMC technical lead for drug product development projects acting as a key liaison between clients and internal cross-functional teams.
• Lead the development optimization and scale-up of drug product processes ensuring robust manufacturing processes for clinical and commercial production including capacity planning to support client programs.
• Develop and implement the sequence to vial strategy for the client facing program management team aligning with overall company goals and objectives that enable optimized client program timelines.
• Contribute to business development efforts by supporting technical discussions proposal development and client onboarding.
• Continuously evaluate and implement new technologies and process improvements to enhance service offerings.
• Provide strategic input on CMC development plans risk assessments and regulatory strategies tailored to client needs and product lifecycle stage working with key internal stakeholders ensuring all CMC activities comply with regulatory requirements (FDA EMA etc.) and industry standards.
• Support the preparation and review of CMC documentation for regulatory submissions (INDs NDAs IMPDs etc.).
• Coordinate cross-functional teams including R&D quality regulatory and clinical to support CMC activities.

The essential requirements of the job include:

• B.S. or B.A. required. Masters degree in chemical engineering chemistry pharmaceutical sciences or a related scientific discipline highly preferred.

• Prefer 10 years of experience in pharmaceutical drug product development with at least 35 years in a CDMO or client-facing role.

• Proven expertise in formulation and process development across multiple dosage forms.

• Strong understanding of regulatory requirements and industry standards.

• Proven experience in managing CDMOs and external vendors.

• Excellent project management organizational and communication skills.

• Ability to work collaboratively with cross-functional teams.

• Up to 50% travel possible.

The salary range for this role is $185000- $215000. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future.

This job is also eligible for bonus/incentive pay.

We offer comprehensive package of benefits including paid time off medical/dental/vision insurance and 401(k) to eligible employees.

Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of any bonus commission benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole discretion unless and until paid and may be modified at the Companys sole discretion consistent with the law.

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Join our winning team today. Together well accelerate the real-life impact of tomorrows science and technology. We partner with customers across the globe to help them solve their most complex challenges architecting solutions that bring the power of science to life.

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