Technical Writer - Pharmaceutical Manufacturing
Job Type :
Required Years of Experience :
Required Education :
Job Industry :
Job Category :
Pharmaceutical Operational Support
Job Description :
Main responsibilities include the following:
• Develop/edit a broad range of technical documents related to biopharmaceutical raw materials, including memos, assessments, specifications, and reports based upon compilation and analysis of supplier-provided and internal data.
• Compile raw material information from various sources (e.g. suppliers, CMOs, internal sites., regulatory/industry, compendia); organize data for broader use within the LM Material Science team.
• Conduct supplier-initiated/CMO-initiated change impact assessments.
• Support life cycle management of raw materials used in the clinical and commercial supply chain as part of tech transfer to both internal and external manufacturing sites.
• Maintain documentation, adhering to standards, templates, and best practices, in the document management system.
• Track tasks to support project completion and reporting.
Additional Responsibilities may include the following:
• Actively participate on cross-functional R&D and manufacturing teams tasked with the following:
− Managing and improving the Material Qualification process in close collaboration with partners in procurement, quality, and technical operations.
− Reviewing and implementing industry and regulatory requirements for raw materials.
− Designing and implementing raw material risk assessments.
− Collaborating with raw material suppliers and internal partners to establish effective raw materials control strategies.
• Support raw material investigations and life cycle activities related to raw materials.
• Develop effective trending methodologies for raw materials, including statistical process control and metrics.
• Support enhanced characterization and data analysis (latent variable statistical models).
• Support supplier audits/selection.
• In close collaboration with API and Drug Product technical teams, formulate characterization plans to advance understanding of raw materials in manufacturing processes and formulations.
• Participate in meetings to share information, knowledge, ideas, and judgment to help establish valid scientific directions in product development or investigations
• Ensure compliance with safety, GMP, quality and scientific principles
Required Qualifications :
• Bachelor’s in chemistry, Biology, Materials Science and Engineering, Biochemical Engineering, Chemical Engineering, or Pharmacy/Pharmaceutics required; Masters, PhD, or PharmD strongly preferred.
• 5+ years of Technical Writing Experience in a Pharmaceutical environment
• Superior written and verbal communications skills
• Excellent command of the English language and grammatical application thereof
• Proficient with MS Word, including TOC, creating/using styles, footnotes, and cross references
• Competent with MS Excel, PowerPoint, and Outlook
• Familiar with SharePoint and electronic document management systems
• Able to multi-task and quickly adjust to changing priorities without sacrificing quality or timely completion of tasks
• 6-8 years of industry experience
• Demonstrated competency and experience with raw material specifications development and management, including compendia testing
• Demonstrated competency and experience in product development within the pharmaceutical industry