Scientific and Technical Writer, Process Deve

AtomVie Global Radiopharma•Hamilton, ON

79d•CA$0 - CA$77,000•Onsite

About The Position

AtomVie Global Radiopharma Inc. is a global leading GMP manufacturer and distributor of clinical and commercial radiopharmaceuticals. We work with our partners to transform patients’ lives by advancing high-quality drugs for the treatment and diagnosis of diseases. We are a community that challenges ourselves professionally, takes pride in what we can accomplish together and values the impact we can make with our partners and patients across the globe. Start your career with AtomVie today and help us achieve our vision: to transform lives by revolutionizing healthcare. The Scientific and Technical Writer, Process Development is an advanced-level documentation specialist embedded within the Process Development team. This role provides hands-on technical, scientific, and operational writing support to process chemists/scientists, and manufacturing operators across development, validation, and clinical supply programs. The incumbent authors, reviews, and manages a broad range of GMP documentation supporting process development, radiopharmaceutical manufacturing, and technology translation. The role works cross-functionally with internal departments and external stakeholders and requires strong scientific judgment, organization, and attention to detail. This posting is for an existing vacancy to support the expansion of the company. Location: AtomVie Global Radiopharma Inc, Hamilton ON (Onsite).

Requirements

Minimum 3 years of hands-on experience in a pharmaceutical GMP environment with demonstrated expertise in quality and technical documentation.
Proven scientific writing experience, including technical reports, development documentation, or peer-reviewed publications.
Ability to interpret experimental data and translate scientific results into clear, structured, regulatory-compliant documentation.
Experience supporting process development, manufacturing, or technology transfer programs.
Strong written and verbal communication skills in English, with excellent grammar and composition.
Proficiency with standard office software (Word, Excel, PowerPoint, Project).
Solid understanding of GMP regulations and pharmaceutical documentation practices.
Ability to work independently and collaboratively in a cross-functional scientific environment.
Strong time-management and prioritization skills with the ability to manage multiple deliverables.
Flexibility to support a 7-day operational environment as required.
Frequent walking between buildings, manufacturing suites, and/or transit between sites.
Master’s degree in Chemistry or Chemical Engineering. Master’s degree in life sciences, pharmaceutical sciences, or engineering disciplines will also be considered.

Nice To Haves

Background in organic chemistry, process chemistry, or related disciplines is an asset.

Responsibilities

Plan, implement, and successfully complete assigned documentation related to process development, validation, and radiopharmaceutical manufacturing while ensuring high quality and GMP compliance.
Ensure documentation activities align with client-driven timelines; work with management to accommodate shifting priorities and last-minute changes.
Author, revise, own, and manage the full lifecycle of technical and quality documentation, including, but not limited to, standard operating procedures (SOPs), master batch records, control forms, process development reports, non-conformance reports, CAPAs, root cause analyses, risk assessments, etc.
Initiate, manage, and close change controls and associated CAPAs in a timely manner.
Collect and compile supporting data and documentation for change control submissions.
Improve and develop documentation templates to support efficiency and consistency.
Coordinate document development and review with colleagues within the Process Development team and act as a documentation point of contact for cross-functional stakeholders.
Support documentation requirements related to new equipment purchases and installations (e.g., URS, SOPs, validation documentation).
Prepare documentation summaries and presentations for internal and client-facing reviews; participate in client meetings as required.
Provide guidance and mentorship on technical writing best practices and data presentation.
Escalate deviations or documentation issues promptly to appropriate management.
Must stay current with Health Canada, FDA, and EU GMP requirements for sterile pharmaceuticals, International compendia (USP, EP, JP), and Internal business processes and work orders.