Mantell Associates
Mantell Associates is currently partnered with a dynamic and growth-oriented CDMO specializing in drug product development and manufacturing, who is seeking a detail-oriented Technical Writer, Operations to join their West Coast team.
This technical role is instrumental in ensuring clarity, accuracy, and regulatory compliance in all operational documentation supporting manufacturing, quality, and regulatory processes.
Technical Writer, Operations – Responsibilities:
- Create, review, and maintain high-quality standard operating procedures (SOPs), batch records, work instructions, and validation documentation (e.g., cleaning and process validation protocols)
- Collaborate with cross-functional teams like Manufacturing, Quality Assurance, Engineering, and Regulatory to ensure documentation is accurate, clear, and aligned with cGMP and company standards
- Translate complex technical and scientific processes into well-structured, easy-to-understand documents
- Maintain and continuously improve documentation across Quality Systems, including adopting best practices and ensuring adherence to regulatory expectations
- Facilitate content clarity, version control, and accessibility – supporting audits and regulatory inspections as needed
- Train and support operations teams on proper document use and compliance aspects
Technical Writer, Operations – Requirements:
- 3 years of experience in technical writing within pharmaceutical, CDMO, or biotech environments—particularly with drug product and manufacturing documentation
- Strong knowledge of cGMP regulations and experience developing SOPs, batch records, or validation documentation
- Excellent writing, editing, and organizational skills – demonstrated ability to translate technical information into concise, user-friendly documents
- Detail-oriented mindset with rigorous attention to accuracy and clarity; proficient in document control systems
- Capable of working collaboratively across diverse teams and balancing multiple priorities in a fast-paced setting
- Must be based on the West Coast of the USA and eligible to work without visa sponsorship
Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us at 44 (0)20 3854 7700.