Vice President of CMC Radiopharmaceutical Process Development
2 months ago
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 Vice President of CMC Radiopharmaceutical Process Development to lead the process development and GMP manufacturing of Abdera’s novel antibody guided radiopharmaceutical for clinical trials. The Vice Preside of CMC Radiopharmaceutical Process Development will provide oversights to cell line development, antibody process development and scale up, conjugation and radio drug substance and drug product development and GMP manufacturing. This is a critical leadership role who will build and lead the team to develop robust radiolabeling processes, formulations, and test methods for the transition of product candidates from the pre-clinical to the clinical phase of the study.
Salary Range: US$ 290K - 325K
Responsibilities
Build team and develop talents
- Manages and leads the CMC process development team for drug substances and drug products from pre-clinical through commercial.
- Leads CMC Team to develop strong working relationships with key stakeholders within and outside of Abdera (peers, contractors, biotech/pharma industry community)
- Work collaboratively with functional management in technical research and development.
- Drive a culture of quality and compliance.
- Provide technical and strategic leadership for the process development of antibody, linker-chelator, conjugation, radiopharmaceutical drug substance, drug product, and final formulation.
- Selects third-party manufacturers and provide oversight to process development and scale up of new molecules.
- Accountable for the technical transfer and scale up of GMP manufacturing.
- Manage the team that oversees contract manufacturing operations for the company’s drug substances and drug products and acts as primary liaison with contractor(s)
- Works with Quality Assurance to implement SOPs and guidelines related to the production, planning, disposition and management, materials, etc.
- Works with Regulatory, QA and Management to ensure that all company policies are adhered to, and all external manufacturing activities comply with relevant regulations.
- Partner with analytical and QC to define and execute product characterization, analytical release testing, stability studies and investigations, as required.
- Ensure robust product stewardship and end-to-end technical oversight of process development processes, across all stages of product development lifecycle.
- Encourage the identification and implementation of new technologies.
- PhD in Radiochemistry, or related discipline with 10+ years of experience in CMC development and scale up in relevant biologics and peptides metal chelates chemistry development.
- Radiopharmaceutical drug substance and drug product development experience and quality control is required.
- Analytical chemistry and knowledgeable in HPLC separation science
- Working with radiopharmaceuticals, with a good understanding of the radiation safety regulations and guidelines
- Hands on experience writing CMC sections of regulatory submissions (IND, NDA, and
- Hands on experience writing CMC sections of regulatory submissions (IND, NDA, and
- equivalent) and clinical/commercial development and manufacturing in the biotechnology or pharmaceutical industry.
- Experience in leading and direct management of process development, and manufacturing.
- Excellent leadership, managerial and communications skills in a cross-functional environment
- Skilled in building team and developing talents.
- Good understanding of cGMP and FDA regulations and guidelines
- Deep knowledge of global CMC-related regulatory requirements and guidelines
- Proficiency in analysis of scientific data and results with ability to review scientific documents including reports, publications, and regulatory submissions
- Excellent written and verbal communication skills; strong communicator and influencer within all levels of the organization, including executive leadership
- Strong analytical capabilities, including quantitative and qualitative assessment skills and demonstrated critical thinking skills
- Ability to build rapport with all levels of organization
- Team-oriented, progressive thinker who enjoys participating in an innovative and creative work environment
- Ability to operate in a fast-paced, multi-disciplinary industrial environment.
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.
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