Chemistry

Senior Director/Director, Analytical Development Direct Hire MA

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Job ID: 16112 Direct Hire MA

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Our client is a mid-sized, public, therapeutics company in the Cambridge area and they are growing!  They are seeking an experienced Analytical Development leader to join their CMC team and lead a team of experienced Scientists.  

The main functions of this role are; leading analytical development function, technology transfer, and oversight of activities at external partners.  

Responsibilities include but are not limited to;
•  Lead drug substance and product analytical development from early development to commercialization.
•  Manage a team of Analytical Development Scientists and staff.
•  Developing analytical controls strategy and overseeing activities at contract development and manufacturing organizations globally.
•  Author technical reports and protocols and provide input and data for regulatory submissions.

Formal descriptions can be supplied for interested candidates. 

Qualified candidates will have a PhD. or Master’s Degree in Chemistry and 10 - 15+ years of experience in relevant CMC or Development groups in a biotechnology or pharmaceutical setting.  Must have 5+ years in managing, as a point person, contract development and manufacturing organizations.  Must have experience with oral solid dose, small-molecule drug substance and/or drug product.        

Must be authorized to work in the US indefinitely to be considered.  Relocation assistance is available for qualified candidates.    

All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.

Sr. Associate Scientist, Analytical Development Direct Hire MA

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Job ID: 16096 Direct Hire MA

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Our client is one of the top cell & gene therapy companies in the Cambridge/Boston area.  This role is with a mid-size company and they have a culture that can't be beat. Don't miss your chance to make a significant impact for patients afflicted with rare diseases and cancer. 

The main function of this role is to support assay qualification and development activities and interact with CMOs and other partners in a viral gene therapy platform.

Responsibilities include but are not limited to;
•  Analytical assays such as qPCR, ELISA, and gel electrophoresis 
•  Cell culture with CD34+ cells, T-cells and performance and qualification of cell based assays and potency assays
•  Serve in a cross-functional and highly visible position that will require active collaboration with the other parts of the process development and quality teams
•  Generate, manage, evaluate, and maintain critical data and participate in writing/ reviewing analytical development and characterization plans and protocols, analyzing critical data and managing experimental timelines
• Assist in the generation, review and approval of technical reports and prepare scientific presentations

Formal descriptions can be supplied for interested candidates. 

Qualified candidates will have a BS or MS degree in Biology/Biochemistry or a related discipline and 7+ years of experience.  More experienced candidates welcome and title and pay will be commensurate with experience.  

Must be authorized to work in the US indefinitely to be considered and must be commutable to the Cambridge area.  

All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.