Fusion Pharmaceuticals, a member of the AstraZeneca Group, is a clinical-stage oncology company focused on developing next-generation radioconjugates (RCs) as precision medicines. Fusion connects alpha particle emitting isotopes to various targeting molecules to selectively deliver the alpha emitting payloads to tumors. Fusion’s clinical portfolio includes: FPI-2265 targeting prostate specific membrane antigen (PSMA) for metastatic castration resistant prostate cancer currently in a Phase 2 trial; FPI-1434 targeting insulin-like growth factor 1 receptor currently in a Phase 1 trial, and FPI-2068, a bispecific IgG-based EGFR-cMET targeted radioconjugate currently in a Phase 1 trial. In addition, Fusion is pursuing combination programs between RCs and DNA Damage Response Inhibitors (DDRis) and immune-oncology agents. Fusion has a fully operational Good Manufacturing Practice (GMP) compliant state-of-the-art radiopharmaceutical manufacturing facility to meet supply demand for Fusion's growing pipeline of RCs.
As a CMC Technical Writer reporting into the Sr. Manager, Radiopharmaceutical CMC you will be involved in the authoring of CMC modules for Phase III studies through to marketing/commercialization. As part of Fusions radiopharmaceutical manufacturing department, the CMC Technical Writer will support time critical CMC Regulatory submissions. This role will liaise with other CMC and non-CMC functions, draft needed regulatory content and collaborate in cross-functional teams.
This position is ideally based in Hamilton, ON, or Boston, MA. Some travel may be required to CDMO sites and/or to the Hamilton Headquarters.
Responsibilities:
- Authoring and maintenance of CMC modules for Fusions lead asset.
- Interpret and apply global/regional CMC regulatory guidelines and regulations.
- Capable of sourcing information from IND enabling studies for generation of CMC module content.
- Extract and summarize scientific information from development reports and identify details required for regulatory submissions.
- Organize data to support the group’s function with answering questions, information request from regulatory agencies such as the FDA, Health Canada or EMEA (including relevant country specific authorities).
Qualifications
- A minimum BSc in chemistry or health sciences (life sci) is required.
- 3+ years of experience in the pharmaceutical industry is required
- Prior radiopharmaceuticals experience is ideal.
- Experience in owning and authoring the relevant CMC sections of INDs, NDAs, BLAs, CTAs, IMPDs.
- Experience in writing late stage (Phase 3 and beyond) is essential.
- Extensive knowledge of eCTD structure and subsections, including appendices
- Experience with ERV (RIM) systems will be considered an asset.
- Knowledge in processes development for pharmaceuticals (manufacturing and quality controls) is a must.
- Knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing and analytical and process development.
- Knowledge of product lifecycle – Product and process development, clinical trials, validation and regulatory submissions, commercial GMP manufacturing.
- Working knowledge of regulatory requirements for biologics, pharmaceuticals and medical devices.
- Organized with proven ability to work independently.
- Excel working in a collaborative environment as a member of a multidisciplinary team.
Additional considerations:
- Must have experience in technical writing and proficient in high quality writing.
- Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities.
- Must have good time management skills, capable of timely delivery of CMC sections.
- Must be flexible and able to handle changing priorities.
- Ability to operate with an integrated view of CMC strategy risks/benefits and company needs.
Fusion Pharmaceuticals is an equal opportunity employer that is committed to inclusive, barrier-free recruitment and selection processes, if contacted for an interview, please advise Human Resources if you require accommodation.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual, gender identity, national origin, disability, or status as a protected veteran.
