Scope of Work:
In support of preparation of the CMC sections of the BLA for biosimilar products, CMC report writer responsible to develop body of required CMC technical reports.
Provide approved reports to client and/or their CRO. Focus on biologics process development and validation, including cell culture, purification and fill/finish. Additional support in other CMC areas also may be required.
- Work with client to access source materials:
- Approved protocols
- Executed protocols and worksheets
- Data reports and raw data
- Subject matter expert and stakeholder input and knowledge
- Document templates and tools
- Leveraging source materials to develop technical reports. Reports may be written from-scratch or through adaptation as appropriate. Reports to be:
- In alignment with client reports formats/templates
- In full agreement with source materials
- Accurate and true to the data
- Aligned with the protocol/program requirements and acceptance criteria
- Defendable to an auditor and regulatory agency
- Utilize existing client processes and tools throughout execution.
- Proofread all reports for:
- Language and grammar
- Correction of ambiguous or confusing wording
- Ensure integrity of content; to not change meaning
- Do the “heavy-lifting”; minimize client resources wherever possible.
- Follow-up with reviewers and stakeholders to ensure reports meet project timelines.
- Apply cGMP/CMC knowledge and expertise when developing the reports.
- Partner with client team members to identify issues, formulate recommendations, and execute solutions, as applicable.
- Lead and facilitate report review meetings. Focus on reconciling feedback and adjourning with approvable reports.
- Manage report approval process.
- For specific projects, develop and manage a report tracker that:
- Contains a complete list of all reports in scope
- Lists due dates for each step of the development and approval process
- Aligns with the client project milestones
- Captures status of each report; includes those that are late, with whom, and why
- Send routine progress reports to the client project lead, including updated report tracker, summary of notable events, areas of concern, and look ahead.
- Provide a list of parking lot and open items (if any) at time of handoff.
- Work closely with other CMC report writer(s) to ensure consistency and cohesion across the body of reports in voice, tone, format, and style.
- Accommodate teleconferences with individuals in other geographies as required.
- Be available for domestic travel as required.
- Work to be performed at client site.
- Assist with related CMC documentation and BLA preparation activities, as requested.
- 15-20 years in biologics manufacturing, particularly parenteral/sterile filling of injectable products. Engineering, manufacturing, or CMC-related background (methods development, stability, product development).
- Excellent writing skills, ability to write from scratch, leverage content from variety of sources including LIMS data, Excel spreadsheets, protocols, executed protocols, lab notebooks, PDFs, etc.
- Experience writing spectrum of technical development reports in biologics environment.
- Must be comfortable working under pressure in fast-paced environment with minimal guidance
- Well-directed to work independently; cannot be high maintenance
- Excellent interpersonal skills.