Development Technical Writer (Process & Analytical Development)

Cellipont Bioservices • The Woodlands, TX

43d

About The Position

Cellipont Bioservices (CPB) is growing, and we are looking for a Technical Writer for Process & Analytical Development Departments who believes in the potential of bridging client's discoveries to patient cures.
The Technical Writer will be responsible for working closely with the Process & Analytical development teams to support critical documentation and data generation.
The Technical Writer is responsible for creating, reviewing and approving process and analytical records, such as protocols, reports, SOPs, work instructions, batch records, and deviations to support the development, transfer and characterization of Advanced Therapy Medicinal Products (ATMPs, e.g. cell therapy) processes and analytics. This position will work cross-functionally with Manufacturing Science and Technology (MSAT), Manufacturing, Quality, Facilities and Project Management departments. We're looking for a candidate with strong writing skills and comprehensive technical knowledge and understanding of processes and analytical methods.
The technical writer will translate complex ATMPs processes and analytics into clear, cohesive, compelling, executable, and compliant documentation.

Requirements

• Bachelor's Degree in Life Sciences preferred with a minimum of 1-2+ years of direct industry experience.
• Experience writing and revising protocols, reports, SOPs, work instructions, batch records, equipment documentation, and deviations, among others.
• Strong writing and verbal communication skills with comprehensive technical knowledge and understanding of ATMPs processes and analytics.
• Ability to read, understand, and interpret technical instructions and data is required.
• Effective collaboration skills with cross-functional scientific teams and clients to gather information/data from multiple sources.
• Strong organizational and time-management skills with the ability to manage multiple documents and deadlines.
• Understanding the Good Documentation Practices (GDP) and ALCOA principles.
• Proficiency with standard documentation tools and document control practices.

Responsibilities

• Collaborate with Process and Analytical Scientists to write, review and approve technical protocols, reports, SOPs, work instructions, batch records, sampling plan, equipment documentation, deviations and other relevant documents for CPB and clients.
• Produced high-quality documentation that meets standards and suits its intended use.
• Maintain standardized and consistent documentation for the recording of processes and analytics.
• Perform control checks for accuracy, grammar, clarity, format, and completeness prior to approval of documents.
• Monitor and track documentation status against key timelines and milestones.
• Collaborate with Process and Analytical Scientists to compile and review the data generated during the development, technical transfer, and qualification of processes and analytics.
• Identify opportunities to streamline the development documentation to support continuous improvement initiatives of processes and analytics.
• Write, review and approve documentation for new laboratory equipment, deviations, investigations, and CAPAs.
• Train and coach scientists in effective scientific writing principles and document preparation.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level