CMC Technical Writer
Fusion Pharmaceuticals
Date: 2 days ago
City: Hamilton, ON
Contract type: Full time

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
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.
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).
- 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.
- 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.
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.
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