Scientist, CMC Analytical Development 

Scientist, CMC Analytical Development 

What you will do

• Design, execute and manage molecular biological assay development, transfer, and validation for lot release testing and characterization
• Execute and support development studies for molecule/process/product characterization and comparability studies to support AAV products. 
• Support other analytical development activities outside of molecular biology assay development to help facilitate the progression
• Assist in technical diligence efforts in support of the selection of CDMOs/CTOs for biological assay development/testing or other analytical testing as needed.
   

Who you are:

• Degree in a life science discipline and experience in biotech or phama industry [BS (7+ years), MS (5+ years), or PhD (1+ years)] with a focus on analytical development for gene therapy
• Expertise in analytical techniques routinely used to test vector products, including ddPCR/qPCR, DNA sequencing, ELISA, and electrophoresis
• Experience with method development, validation, and application of analytical methods for product development, characterization, and QC testing.
• Experience in a quality control environment is preferred.
• Assist in the preparation of CMC regulatory submissions, including providing data summaries and trend analysis.
• Adhere to internal and external regulatory (ICH, FDA, EMA, etc.) and GMP requirements to develop and establish analytical policy and process to facilitate department operations.

Why work here

• Small team environment encourages interdivisional collaboration. You’ll always have your voice heard and can wear many hats!
• Impact: Have a positive influence both as part of a lean team where your voice can be heard, as well as on the company as a whole.

What does this position pay? 

Compensation is determined by several factors which may include skillset, experience level, and geographic location. 

The expected range for this role is $38-60/hour.

Please note this range is an estimate and actual pay may vary based on qualifications and experience.

Please email your resume to sboddy@provenrecruiting.com if you’d like to work alongside some of the finest professionals in the Biotech industry!
 

Note: We actively support and promote people of various backgrounds, from race, religion, gender to geographical area, university, lifestyle, and personality type. Proven Recruiting is minority-owned, majority women, and is a strong advocate for diversity and inclusion in the broader community. Apply today!
 

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