Associate Director, Radiopharmaceutical Process Development
Our client is a pioneering biotechnology firm specializing in the development of cutting-edge radiopharmaceutical therapies. Their rapid growth is fueled by a robust pipeline of successful projects and strategic investments.
They are seeking an Associate Director of Radiopharmaceutical Process Development to drive the CMC radiopharmaceutical process development for all novel clinical programs. The Associate Director will execute the CMC development plan and IND enabling activities, leading to the clinical manufacturing of the Drug Product. In this role, you will translate pre-clinical/research methods and data to develop cGMP compliant processes and clinical drug product specifications, manage the execution of CMC studies, and author drug substance/product IND sections. Additionally, you will provide technical support and assessment to clinical manufacturing, including root cause analysis, change control, and process optimization. This role will serve as the main liaison between Tech Ops and research as well as the CDMO development team.
Principal Responsibilities
Process Development of Radiopharmaceutical Drug Product (DP)
- Lead the process development of radiopharmaceuticals for phase 1 clinical trials with a multidisciplinary team.
- Participate in the selection team to review RFPs, assess technical fit, and select the appropriate CDMO for development and manufacturing of novel products.
- Develop DP from DC selection to IND submission, including creating technology transfer packages, defining and managing development timelines, designing studies to determine suitable process conditions, and leading process qualification and validation campaigns.
- Write relevant CMC sections and supporting reports for regulatory submissions.
- Execute clinical readiness activities to enable clinical manufacturing.
Technical Support of Clinical Manufacturing
- Provide technical direction to external CDMOs to draft manufacturing documentation.
- Partner with Quality to review manufacturing data and identify opportunities for risk reduction and continuous improvement.
- Support Quality/Regulatory assessments, including batch release, change control, deviations, OOs, and CAPAs.
Liaison Between Research/Pre-Clinical and CMC
- Support the setup and ongoing function of the radiochemistry laboratory.
- Act as the liaison to partner with research radiochemistry and in vivo teams to share best practices and facilitate knowledge exchange.
Qualifications, Education & Experience
- MSc or PhD in scientific fields with 10+ years of experience in the pharmaceutical industry, including radiopharmaceuticals.
- Knowledge of cGMP requirements, aseptic processes, and equipment qualification.
- Experience in writing CMC sections of regulatory submissions and clinical development and manufacturing.
- Experience with antibodies and bioconjugation is a plus.
- Good understanding of radiation regulations and guidelines preferred.
Skills and Abilities
- Strong understanding of cGMP and FDA regulations.
- Excellent written and verbal communication skills.
- Strong analytical capabilities and critical thinking skills.
- Ability to troubleshoot complex problems and build rapport with all levels of the organization.
- Team-oriented, innovative thinker who enjoys a fast-paced, multidisciplinary environment.
