Technical Writer/Scientific - II

This is a remote opportunity, though a hybrid option is available for candidates local to West Point, PA, who prefer working from the office.
There are currently two (2) open positions for this role.

We are seeking a skilled Technical Writer to join our multidisciplinary team focused on the commercialization of biopharmaceutical procedures. In this role, you will bridge the gap between complex science and regulatory compliance by authoring and reviewing Analytical Test Methods and regulatory filing documents. Working closely with method experts and regulatory groups, you will play a vital role in ensuring that QC testing procedures for biologics or vaccines meet stringent commercial standards. This is an excellent opportunity for a detail-oriented professional to contribute to life-saving product launches within a fast-paced, collaborative environment.

Responsibilities

• Author and critically review technical documents, specifically focused on Analytical Test Methods and Regulatory Filing sections.
• Create and revise documentation that is strictly compliant with current Good Manufacturing Practices (cGMP).
• Perform Second Person Review or Second Scientist Review to ensure data integrity and technical accuracy.
• Collaborate with method experts and key stakeholders to translate technical processes into clear, executable procedures.
• Support regulatory submission groups by drafting documents that meet ICH and USP guidelines.
• Lead or participate in group initiatives to develop document standards and templates for the organization.
• Manage document workflows within electronic repository systems to ensure version control and timely approvals.
• Maintain a proactive, service-oriented mindset while working across cross-functional teams to meet project milestones.

Education

• Minimum of a BS/BA in Life Sciences or Engineering is required.
• Master’s degree or PhD is preferred.

Experience

• Industry Background: At least 2 years of experience working in a cGMP laboratory environment, specifically within the biopharmaceutical, biologics, or vaccine industries.
• Technical Writing: Proven experience in technical operations, quality control writing, or commercialization documentation.
• Compliance Knowledge: Familiarity with analytical method validation and transfer according to ICH and USP guidelines is preferred.
• Software Proficiency: Strong skills in the MS Office suite and experience with laboratory data management or document repository systems.
• Core Competencies: Demonstrated ability to work independently, excellent interpersonal skills, and a high level of detail orientation.