Position Summary
- We are seeking a technical writer who will author and review Analytical Test Methods to commercialize procedures for the QC testing area by working closely with method experts.
- The candidate may also author and review documents supporting regulatory submissions working closely with regulatory groups.
- The successful candidate must function well and be able to collaborate in a fast-paced, integrated, multidisciplinary team environment.
Primary Responsibilities:
- Authoring and critically reviewing technical documents including Regulatory Filing sections and Analytical Test Methods.
- Authoring and reviewing documentation compliant with current Good Manufacturing Practices (cGMP), including Second Person Review or Second Scientist Review.
- Participate in group initiatives related to document standards, template development, internal processes, and other aspects of document management.
- Collaborate closely with key stakeholders.
Software Skills: MS Office Suite.
Personality:
- Detail oriented.
- Excellent writing skills.
- Collaborative.
- Good communication and interpersonal skills.
Qualifications:
Education:
- Minimum qualification- BS/BA in life sciences/engineering is required.
- Master's degree/PHD preferred.
Required Experience and Skills:
- At least 2 years working experience in a cGMP laboratory environment.
- Experience in the biopharmaceutical manufacturing industry, such as in biologics or vaccines commercialization, technical operations, or quality control.
- Strong oral and written communication skills.
- Work independently and within cross-functional teams.
- Maintain a proactive and service-oriented mindset.
- Experience with MS Office and document repository systems.
Preferred Experience and Skills:
- Experience with analytical method validation and transfer according to ICH and USP guidelines.
- Experience with laboratory data management systems.