Senior Engineer, Process Development
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 a Senior Engineer, Antibody and Antibody-Conjugate Process Development, 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 Senior Engineer is responsible for process development and manufacturing of antibodies and antibody-chelate-conjugates and drive the related 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 cell culture, purification, and conjugation, as well as familiarity with critically relevant areas such as analytical characterization, formulation, and cell line development.
Strong CMC process development technical background and leadership skills is required. A successful applicant will have prior hands-on experience taking a novel cancer therapy through IND and into clinical trials, building process development team and lab, overseeing external CDMO work, and be comfortable in a fast moving and nimble culture.
Building Antibody and Antibody-Conjugate Process Development Capabilities
- Serve on clinical program CMC teams as process development lead, support product development and ensure successful acceptance of regulatory filings.
- Develop plan and lead process development and manufacturing of antibody and antibody-conjugates and associated CMC requirements.
- Build process development capabilities and standards including process development labs and statistical data analytics
- Provide subject-area expertise in bioprocess and CMC development.
Providing oversight for process development at CDMOs
- Lead and manage CDMOs in the areas of biologics and conjugation manufacturing
- Manage tech transfer and process development activities to enable regulatory filing
- Accountable for clinical manufacturing technical support to advancing clinical stage CMC programs.
- Define and manage technical projects across internal functions and CDMOs with focus and urgency
- Partner and support Quality in technical impact assessment
- Supporting CMC programs and Clinical Trials
- Interact closely with cross-disciplinary project teams to advance technology development efforts, including Analytical Sciences, Quality, Regulatory and other Development groups.
- Author high-quality regulatory submissions and technical reports; independently prepare and present data/findings at department, project team, and senior management meetings.
- Author or review relevant CMC-related sections of regulatory filings and responses to health authorities.
Qualifications, Education and Experience
- Ph.D. in Bioengineering, Biochemistry, Biology, or related scientific discipline, plus 10+ years relevant industry experience; or M.S. with 15+ years, or B.S. with 18+ years
- Experience with clinical process development phases, cGMP operations, and regulatory expectations is essential for success.
Skills & Abilities
- Demonstrated capacity to resolve complex scientific problems with appropriately designed experimentation, including practical experience in experimental approaches. Ability to apply Design of Experiment (DoE) approaches, where appropriate
- Experience in performing process characterization (PC) studies, process performance qualification (PPQ), and other late-stage development activities.
- Experience in preparing regulatory filings including IND/IMPD applications, amendments, and comparability studies.
- Experience and knowledge in starting up Process Development Labs.
- Experience working effectively with contract manufacturers (CDMOs).
- Strong interpersonal and collaboration skills.
- Excellent verbal and written communication skills; ability to lead Process Development function as part of multi-faceted projects.
- Ability to operate in a fast-paced, multi-disciplinary industrial environment.
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.