Join Our Crew

Responsibilities Include

• Authors, reviews, and assists with submission of CMC documentation for INDs, IMPDs, BLAs and MAAs for cell and gene therapy programs.
• Authors, reviews, and assists with completion of technical documentation to support CMC Technical organization (e.g. technical transfer documentation, regulatory request for information, etc.).
• Manages document preparation timelines and communicates with team members to maintain awareness of expectations, enable timely reviews, achieve milestones, and document deliverables.
• Ensures accuracy, completeness, and compliance of regulatory submissions with regulatory requirements and company standards.
• Participates in CMC change controls to ensure released products are manufactured in agreement with established regulatory submissions and regulatory guidance.
• Works with technical teams to convert technical data and results into reports in support of regulatory submissions.
• Reviews and edits documents including those authored by others both internally and externally.
• Is a collaborative team player participating in both internal and external project team meetings as needed and offers proactive solutions and advice to team members.
• Remains compliant with company training, and authors and/or reviews departmental (CMC and regulatory) SOPs as needed.
• Identifies opportunities for process improvements and efficiency enhancements in CMC-related activities.
• Implement best practices and lessons learned to optimize regulatory processes and streamline project execution.
• Performs other activities as assigned.

Required Qualifications

• Degree in Biological Sciences, Chemistry, Chemical Engineer or equivalent;
• Senior Manager: BS or MS with 6 years’ experience or Ph.D. and 2 years’ experience in a technical writing capacity
• Manager: BS or MS with 3-5 years’ experience or Ph.D. and 0 years’ experience in a technical writing capacity
• Familiarity with the key regulatory requirements and guidelines for drug development and manufacturing, including FDA, EMA, and ICH guidelines.
• Experience in reviewing and writing regulatory submission documents for global regulatory filings such as IMPD, INDs, MAAs, NDAs, and BLAs, is preferred.
• Ability to critically analyze, synthesize, and present complex information in well-constructed documents.
• Working knowledge of drug/biologics CMC development, data analysis, and tech transfer.
• Ability to support multiple projects and to prioritize work independently.
• Ability to comply with company and/or industry style guides and templates.
• Ability to guide and train others in the writing of technical documentation.
• Ability to work effectively in a cross-functional team environment.
• Fluent written and spoken English with excellent attention to detail relative to consistency, grammar, syntax, and scientific accuracy.
• Advanced MS Skills in Word, Excel, Powerpoint, Viso and Adobe Pro
• Confidence to present to management, peers, and scientific or business collaborators.
• Strong written and verbal communication skills.
• Strong team orientation and passion for continuous self-development.
• Experience in the biotech industry or in a startup industrial setting is preferred.

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