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The Fountain Group

CMC Technical Writer III

The Fountain Group, Santa Monica, California, United States, 90403

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We are currently seeking a

CMC Technical Writer III

for a prominent

Pharmaceutical

client of ours. This position is

Remote (PST Hours) . Details for the position are as follows:

Job Description:

Pay: 75.00-85.00/hr. Length of Assignment: 6 months to start with potential for extension or conversion. Seeking a highly motivated individual with late-phase CMC technical experience, including technical and regulatory submission experience. In the near-term, this role will support time critical CMC Regulatory submissions. Longer-term, this individual will be embedded in technical teams within the Process Development department supporting CMC aspects of our growing pipeline projects. Author and Finalize appropriate Module 3 documents and Response to Agency Questions in collaboration with Regulatory CMC and Technical Subject Matter Experts. Experience in analytical method development of vector and T cell, extended characterization of vector and T cell products, awareness of ICHs and global compendial requirements governing analytical development and characterization/comparability of Advanced Therapy Medicinal Products and vector intermediates is nice to have but not required. Thorough knowledge of biologics analytical and process development is essential. Cell therapy process development experience is nice to have but not required. Writing about analytical methods. Supporting CMC regulatory filings, writing change controls, writing deviations as they relate to quality activities. FDA and EMA Filings. BLA filing is the most critical.

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