To discuss more about this job opportunity, please reach out to Deepak Arya (LinkedIn URL - www.linkedin.com/in/deepak-arya-8a79aa22a/), email your updated resume at Email - deepak.arya@collabera.com. Thank you!

Pay range: $65 to $70/hr.

Industry: Biopharmaceutical

Location: 100% Remote

Key Responsibilities: 

• Client is seeking a highly motivated individual with late-phase CMC technical experience, including technical and regulatory submission experience.  
• This position is part of the Process Development organization and in this role, this individual will be supporting the internal Process Development teams. 
• 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. 

 Qualification: 

• Bachelor's, Master's Degree, or PhD in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology, Biology, Biochemistry or equivalent with 7+ years (Bachelors), 5+ years (Masters), 3+ years (PhD) of relevant experience.
• Experience CMC/Module 3 regulatory submissions.
• Experience in technical writing and proficient in high quality writing.