AD, Drug Product

Meet Life Sciences; Watertown (MA); On-site; USD 195,000 - 200,000; Full time

Job summary

Meet Life Sciences Ltd. is seeking an Associate Director of Drug Product Technical Services to lead validation activities for injectable assets in late-stage trials.

This on-site role is based in Watertown, MA and requires collaboration with regulatory, manufacturing, quality and development teams to ensure robust validation and a smooth transition from clinical to commercial manufacturing. The ideal candidate will drive formulation development for liquid and lyophilized products, oversee

Qualifications

• 10+ years in aseptic drug product formulation, validation and GMP manufacturing.
• Experience with liquid and lyophilized formulations, preferably oligonucleotides or biologics.
• Proven track record leading process validation campaigns for Phase III products.
• Experience with pre-filled syringes, autoinjectors, or combination products is highly desirable.
• Ability to develop and author regulatory submissions and to manage multiple projects.

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 CMOs, 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 met.
• Collaborate with multidisciplinary teams to foster continuous process improvements.
• Review batch records, process instructions, and quality documentation to ensure adherence to standards.

Skills

Aseptic drug product formulation

Drug product validation

GMP manufacturing experience

Regulatory submissions

Project management

Cross-functional collaboration

Communication skills

Tools

CMO management

Job description

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.

Sometimes we use AI to draft job adverts using information from our CRM as part of our effort to work more efficiently so we can focus on what matters most: getting to know you. If you apply, a real person from our team will review your details and reach out. We’re committed to transparency, fairness, and human connection.