AD, Drug Product

Overview
Join a pioneering organization dedicated to transforming human health through innovative RNA-based medicines. This role offers an exciting opportunity to lead drug product validation activities for advanced clinical-stage assets, supporting cutting-edge therapies that could make a real difference in patients’ lives. If you’re passionate about scientific excellence and want to grow within a dynamic biotech environment, this could be the perfect fit.

About our client
Our client operates at the forefront of the life sciences sector, focused on harnessing RNA technologies to develop transformative treatments. Their mission is to push the boundaries of science to unlock human potential and improve health outcomes globally. They are committed to scientific innovation, collaboration, and a strong pipeline of pipeline assets that aim to address unmet medical needs.

The opportunity (Role summary)
As Associate Director of Drug Product Technical Services, you will oversee validation activities for injectable drug assets in late-stage clinical trials. You will collaborate with cross-functional teams—regulatory, manufacturing, quality, and process development—to ensure robust product validation and smooth transition from clinical to commercial phases. This on-site role is vital for maintaining the integrity and quality of key therapies, ultimately helping bring innovative medicines to patients faster.

Key responsibilities

• Drive formulation development and validation of liquid and lyophilized drug presentations to meet phase-specific requirements.
• Lead process validation campaigns to prepare for regulatory approval and commercial manufacturing.
• Manage technology transfer activities with Contract Manufacturing Organizations, ensuring GMP compliance and supply continuity.
• Author critical regulatory documentation, including sections of submissions related to drug product manufacturing.
• Oversee external manufacturing partnerships, ensuring timelines and quality standards are strictly maintained.
• Collaborate with multidisciplinary teams to foster continuous process improvements and troubleshoot technical issues.
• Review batch records, process instructions, and quality documentation to ensure adherence to standards.

What you’ll bring

• approximately 10+ years of experience in aseptic drug product formulation, validation, and manufacturing in a GMP environment.
• Strong expertise in liquid and lyophilized formulations, preferably with oligonucleotides or biologics.
• Proven record of managing process validation campaigns, especially for Phase III products.
• Experience working with pre-filled syringes, autoinjectors, or combination products is highly desirable.
• Ability to develop and author regulatory submissions, with excellent communication skills.
• Demonstrated ability to independently prioritize and manage multiple projects in a fast-paced biotech setting.
• Practical knowledge of cGMP regulations and CMO management.

Compensation
This role offers a competitive base salary ranging from USD 195,000 to 200,000, complemented by RSUs, stock options, and a small sign-on bonus. While no relocation assistance is provided, you will join a company with a strong financial outlook and a mission-driven culture, dedicated to innovation and patient impact.

Apply now to become a key leader in advancing life-saving therapies and shaping the future of RNA medicines. A dedicated team awaits your expertise, and your contribution could accelerate revolutionary treatments to the patients who need them most.

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