Associate Director, Antibody And Antibody-Conjugate Downstream Process Design

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

Abdera is seeking an Associate Director, Antibody and Antibody-Conjugate Downstream Process Design to lead process development of antibody and drug conjugation that advances the company’s clinical programs. This role will be essential to ensure phase-appropriate process development and optimization of antibody and drug conjugate manufacturing of our novel oncology therapy candidates. The candidate will be responsible for process development and manufacturing of antibodies and antibody- conjugates at CDMO partners and supporting all CMC elements throughout the product life cycle of antibody-based radiopharmaceuticals.

The role requires a strong technical background in biologics processing, primarily in the areas of antibody downstream process development and synthesis/purification of antibody-conjugates, as well as familiarity with relevant areas such as cell line development, formulation, and analytical characterization.

Strong CMC process development technical background and leadership skills is required. A successful applicant will have prior hands-on experience taking antibody-conjugates through IND and into clinical trials, overseeing external CDMO’s, and be comfortable in a fast moving and nimble culture.

Principal Responsibilities

• Lead and manage CDMOs in the areas of biologics and conjugation manufacturing.
• Manage tech transfer and process development activities to enable regulatory filing.
• Author or review relevant CMC-related sections of regulatory filings and responses to health authorities.
• Accountable for clinical manufacturing technical support to advancing clinical stage CMC programs.
• Partner and support Quality in technical impact assessment.
• Serve on clinical program CMC teams as process development lead, support product development and ensure successful acceptance of regulatory filings.
• Author high-quality regulatory submissions and technical reports; independently prepare and present data/findings at department, project team, and senior management meetings.
• Develop plan and lead process development and manufacturing of antibody and antibody-conjugates and associated CMC requirements.
• Interact closely with cross-disciplinary project teams to advance technology development efforts, including Analytical Sciences, Quality, Regulatory and other Development groups.

Qualifications, Education & Experience

• Experience in performing process characterization (PC) studies, process performance qualification (PPQ), and other late-stage development activities.
• Ph.D. in Bioengineering, Biochemistry, Biology, or other related scientific discipline, plus 8+ years relevant industry experience; or M.S. with 12+ years, or B.S. with 18+ years.
• Strong interpersonal and collaboration skills.
• Experience with clinical process development phases, cGMP operations, and regulatory expectations is essential for success.
• Ability to apply Design of Experiment (DoE) approaches, where appropriate
• Experience working effectively with contract manufacturers (CDMOs).
• Ability to operate in a fast-paced, multi-disciplinary industrial environment.
• Demonstrated capacity to resolve complex scientific problems with appropriately designed experimentation, including practical experience in experimental approaches.
• Excellent verbal and written communication skills; ability to lead Process Development function as part of multi-faceted projects.
• Experience in preparing regulatory filings including IND/IMPD applications, amendments, and comparability studies.

Skills & Abilities

• Strong technical background in biologics processing & CMC process development.
• Ability to prioritize, delegate and execute to meet project deadlines.
• Demonstrated ability to manage and coordinate internal and external resources independent from managerial oversight.
• At ease in start-up environment and effectiveness to deliver in low-structured environments.
• Proactive, innovative, with excellent problem-solving skills.
• Willingness to collaborate with team to identify and implement in best practices for optimizing performance.
• Strong organizational, communication and interpersonal skills
• Excellent computer skills (Microsoft Office Suite, Project, Word, Excel, PowerPoint, Outlook, and IXRS/EDC platforms).
• Naturally connects and builds strong relationships with others, demonstrating strong emotional intelligence and an ability to communicate clearly and persuasively.

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

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