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Miltenyi Biotec · 8 hours ago

Technical Writer *PC 1557

Gaithersburg, MD

Full-time

Onsite

Mid Level

$32.64/hr - $38.38/hr

3+ years exp

Miltenyi Biotec is a company focused on revolutionizing biomedical research, and they are seeking an experienced Technical Writer to join their Manufacturing Science and Technology team. The role involves creating and maintaining high-quality documentation for regulatory submissions and manufacturing processes, requiring strong communication skills and a deep understanding of technical and regulatory requirements.

BioinformaticsBiotechnologyHealth CareMedical

No H1B

Responsibilities

Draft and edit documentation: Write and revise a wide range of documents according to regulatory and company standards

Standard Operating Procedures (SOPs): Detailed instructions for performing routine operations

Batch records: Records detailing the manufacturing process of a specific product batch

Protocols and reports: Documents for clinical trials, validation studies, and investigations

Regulatory submissions: Documents submitted to regulatory authorities like the FDA and EMA for drug approval (e.g., INDs, NDAs)

Collaborate with subject matter experts (SMEs): Work with scientists, engineers, quality assurance, and manufacturing staff to gather information and ensure technical accuracy

Investigate and document quality events: Investigate non-conformances (NCRs), deviations, and root causes, then document the findings and the resulting corrective and preventive actions (CAPAs)

Manage document control: Handle documentation throughout its lifecycle, including version control, revisions, and archival, often using an electronic document management system (EDMS)

Ensure regulatory compliance: Maintain deep knowledge of and adhere to regulations such as current Good Manufacturing Practices (cGMP), FDA guidelines, and International Council for Harmonization (ICH) guidelines

Adapt content for different audiences: Tailor writing for multiple audiences, including regulatory agencies, healthcare professionals, and patients

Contribute to process improvement: Analyze and evaluate existing documentation and processes to identify and implement opportunities for enhancement

Qualification

Regulatory complianceDocument management systemsTechnical writingFDA guidelinesGMP documentation standardsBiopharmaceutical processesProcess improvementCollaboration skillsProblem-solving skillsWritten communicationVerbal communication

Required

Bachelor's degree in Life Sciences, Pharmacy, Chemistry, Technical Communication, or a related field; 3+ years of technical writing experience in a regulated pharmaceutical, biotech, or life sciences environment

Strong knowledge of FDA and ICH guidelines, GMP/GLP documentation standards

Excellent written and verbal communication skills

Proficient in Microsoft Office Suite and document management systems

Detail oriented with the ability to organize large amounts of data for clear presentation

Skillful in writing sophisticated processes in an informational and explanatory style

Know-how of process improvement and procedural documentation rules

Good problem-solving skills

Collaboration and team-working skills

Understand industry trends in technical communication, information architecture, and content development

Good eye/hand coordination

Use keyboard/computer/phone

Regular and predictable attendance

Preferred

Understanding of biopharmaceutical processes used to manufacture therapeutics (cell culture, harvest, chromatography purification steps, etc.); viral vectors highly preferred