Associate Director, Radiopharmaceutical Process

1 month ago

Vancouver, Canada Abdera Therapeutics Full time

**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.

**Salary Range - 125 - 165k CAD - Canada**

**Principal Responsibilities**

**Process Development of Radiopharmaceutical DP**
- Working with a multidisciplinary team, this role will lead Abdera’s process development of radiopharmaceuticals for phase 1 clinical trials
- For each new program, be part of the selection team to review RFP, assess technical fit and select the appropriate CDMO for development and manufacturing of Abdera’s novel product
- Lead the process development of DP from DC selection to IND submission, including:

- Create technology transfer package for CDMO’s by translating pre-clinical analytical methods and drug product synthesis to processes suitable for clinical development
- Define and manage DP development program timeline and activities from DC to IND submission
- Design study / experiments to determine suitable process flow, process conditions, materials selection, acceptable range, etc. to enable process lock
- Closely partner with antibody and conjugation process development lead to ensure materials readiness
- Partner with external/internal development lab to define IND enabling study protocols, review study run data, provide feedback throughout the development process
- Lead the execution (with CDMO) of the process qualification and validation campaign and prepare the relevant reports and data for the relevant IND sections.
- Write relevant CMC sections and supporting reports for submission to regulatory agencies (IND to the FDA)
- Execute clinical readiness activities (such as compatibility and transportation studies, aseptic process qualification) to enable clinical manufacturing.
- Drive delivery and execution of CMC program plans for DP Process Development via tracking/reporting key milestones and decision points to meet IND and clinical readiness timeline

**Technical Support of Clinical Manufacturing**
- Partner with internal CMC team, provide technical direction to external CDMO to draft manufacturing documentation including specification, analytical method, batch records, protocols, etc.
- Partner with Quality to provide periodic technical review of manufacturing data, including analysis of trends
- Partner with Quality, Supply Chain, and manufacturing, identify opportunities for risk reduction and continuous improvement within the cGMP manufacturing process
- Provide technical impact assessment to support Quality/Regulatory assessments including but not limited to batch release, change control, deviations, OOs, CAPAs.

**Liaison between Research/pre-clinical and CMC**
- Support the set-up and on-going function of Abdera’s radiochemistry laboratory to support translational development from pre-clinical and clinical activities
- Represent CMC, act as the liaison to partner with research radiochemistry and in-vivo team to share best practices and facilitate knowledge exchange

**Qualifications, Education & Experience**
- Knowledge of cGMP requirements, aseptic process, and equipment qualification.
- Experience in writing CMC sections of regulatory submissions (IND, NDA, and

equivalent) and clinical development and manufacturing in the biotechnology or pharmaceutical industry
- Experience working with antibodies and a working knowledge of bioconjugation of antibodies are a plus.
- Good understanding of the radiation regulations and guidelines preferred

**Skills and Abilities**
- Good understanding of cGMP and FDA regulations and guidelines relating to CMC-related areas
- Excellent written and verbal communication skills; strong communicator and influencer within all levels of the organiza

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