Support the writing of protocols that will be released to both the manufacturing and operations teams.
Assist with report writing to ensure the deliverables meet client expectations for specific projects.
Help with running batch record reviews, ensuring thoroughness and compliance with standards.
Review data protocols to confirm they are both accurate and logically sound, aligning with regulatory requirements.
Have experience working within fill/finish processes, which is crucial for this role.
Possess Process Validation experience, which is integral to ensuring product quality and compliance.
Additional Skills & Qualifications:
Preferably have previous experience working in a Contract Development and Manufacturing Organization (CDMO), which is highly beneficial for this position.
Be comfortable in a client-facing, customer-driven role, demonstrating strong communication skills.
Hold a Bachelor of Science in Biochemistry, Biology, or another relevant life science field, along with 7-10 years of experience.
Have prior experience specifically within fill/finish processes and process validation, further enhancing suitability for the role.