Associate Director CMC Development Operations - Abdera Therapeutics Inc.

Who we are

Abdera Therapeutics Inc. is a precision oncology company developing next-generation targeted radiation therapies - one of the most cutting-edge and highly promising areas of drug development. The company is built on a proprietary modular technology platform optimized for the delivery of radioisotopes to selectively destroy tumor cells while sparing healthy cells. Abdera is using this platform to enable the rapid development of a broad range of safe and efficacious therapies serving cancer patients with limited treatment options.

Abdera Therapeutics is growing rapidly and seeking key new team members who thrive at the cutting-edge of innovation. Come join us and be a part of the ground-breaking team set to unlock the power of targeted radiotherapy!

What we look for

At Abdera Therapeutics, we are looking for curious and committed individuals who are ready for the opportunity to transform the way people living with cancer can be treated. We are relentless in our focus to offer new hope to families facing devastating diagnoses. We are in search of team members who work collaboratively with a diverse group of colleagues, respectfully engaging one another while collectively and inclusively tackling any challenges we may face. We are building an exciting and fast-paced company passionate about discovering and developing tomorrow’s most innovative cancer therapies.

Abdera is seeking an Associate Director CMC Development Operations to drive the radiolabeling process development operations for Abdera’s novel radiotherapies. The Associate Director of CMC Development Operations will play a critical role in building the technical development operations and ensuring the efficient and compliant development activities of the radiolabeling processes, supporting Abdera’s pipelines.

The job is a hybrid role located in our South San Francisco office - 3 days onsite.

Salary Range: 170 - 200k

Principal Responsibilities

• CMC Development Operations Management
• Lead the set-up and start-up of the development laboratories in driving decisions for radiolabeling development laboratory and processes design.
• Identify CAPEX and laboratory supplies requirements.
• Design and implement laboratory operations and processes, such as experiment design and equipment operating procedures.
• Manage the radiolabeling processes development team, as well as supervising the daily operations of the extended on-site CMC team and Radiochemist from the Research Chemistry team.
• Manage and deliver timelines for the radiolabeling development laboratory.
• Report on the team performances and provide project updates to the cross-functional and leadership team.
• Process development
• Accountable for the development of radiolabeling processes, based on the development plan and Drug Product requirements.
• Build and own the CMC technical package for supporting the technology transfer of the developed processes to cGMP manufacturing partners.
• Lead the development activities to improve, scale-up or troubleshoot the radiolabeling processes, by designing/maintaining the experimental and study plans, based on the generated data.
• Act as the liaison between Research and CMC to onboard new programs.
• As a technical SME, be an active member of the technology transfer team, providing insights, peer review of data and technical documents.
• Partner with a cross-functional team (e.g., quality, process engineering, analytical development) to establish the experimental design and in-house studies necessary to reach the CMC team goals.
• Compliance – Radiation Safety
• Support the project team during the licenses and permits application process, and design of the radiation safety program (set-up and start-up phase) for the development laboratories.
• Be the on-site alternate radiation safety officer during the operations of the development laboratories.
• Accountable to maintain the operations in compliance, based on the radiation licenses and permits requirements, by performing the radiation safety manager duties (as defined by the “Duties and Responsibilities of the Radiation Safety Officer for Research and Development Laboratory Facilities”, CDPH 8243 IR4) including but not limited to: Monitor operations and guarantee the safety of the workers/environment, terminate operations if a risk or threat is identified.
• Monitor usage and possession of radioactive substances (incoming isotopes, in-use, waste) and sealed sources.
• Ensure the compliance for staff training, records and documentation.
• Ensure the inspection readiness by performing internal audits of the operations and represent the company (along with the management team) during inspections from the authorities.

Qualifications, Education & Experience

• MSc or PhD in chemistry, radiochemistry with 5+ years of experience in the pharmaceutical industry, including radiopharmaceuticals (radioconjugate antibodies, small molecules and peptides).
• Proven track record of radiolabeling process development, from discovery to early clinical stage, is a must.
• Proven experience and training as (alternate) radiation safety officer duties is an asset.
• TDG/DOT training and certification is an asset. Radiation safety officer (or associate) training certification is an asset.
• Proven experience in radiometals radiolabeling processes development (including Ac-225, Lu-177, In-111, generator-based radiometals) is a must.
• Strong knowledge of NRC (Nuclear Regulatory Commission), and CDPH (California Department of Public Health) is a must.
• Knowledge of DOT regulation is preferred.
• Strong knowledge in ICH development guidelines is preferred.
• Strong communication skills within a cross-functional team, reporting skills to the management team.
• Ability to support regulatory authorities during inspection and interview. Direct inspection experience is preferred.
• Leadership experience is preferred.

Abdera is an equal opportunity employer that is committed to diversity and inclusion in the workplace. At Abdera, we prohibit harassment of any kind and any form of discrimination including but not limited to discrimination based on race, color, sex, religion, marital status, sexual orientation, national origin, disability, veteran status, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.

This commitment is applicable to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship.