Job Details

Overview

Director Drug Product CMC (mRNA LNP, Drug Development) role at Danaher Life Sciences. This position is part of the mRNA CDMO and located in Fargo, ND, with remote work options.

At Aldevron, we shape the future of medicine by advancing science in meaningful ways. We seek a strategic and technically accomplished leader to lead client-facing drug product development and manufacturing programs within our CDMO, driving the design, development, and execution of robust CMC strategies for a diverse portfolio from early-phase to commercial 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.

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 enabling 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 to ensure 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.

Qualifications

• 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.

Compensation & Benefits

The salary range for this role is $185,000 $215,000. 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 and may be modified in the future. This job is eligible for bonus/incentive pay. We offer a 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 wages or compensation until earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or other compensation remains at the Companys sole discretion unless paid and may be modified at the Companys sole discretion, in compliance with the law.

Equal Opportunity

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. For accommodation requests, please contact 1-202-###-#### or ...@danaher.com.

For more information, visit www.danaher.com.

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