Senior / Principal Scientist - AAV Process Development

Proclinical is currently recruiting for a Senior/Principal Scientist of AAV Process Development with biotechnology company located in Cambridge, MA. Successful candidate will carry out both upstream and downstream process development activities for the manufacture of pre-clinical and cGMP grade rAAV products, participate in and lead internal productions, write appropriate documents and carry out technology transfer to assorted CMOs, and finally participating in cGMP manufacture person in plant activities.

Job Responsibilities:

• Perform benchtop and preparative separations of rAAV particles from suspension HEK293 cell lines using various filtration, TFF, centrifugation and chromatographic techniques.
• Develop protocols for viral capsid purification using column chromatography / AKTA protein purification systems.
• Complete concentration and diafiltration processes using various TFF systems.
• Provide support for and lead the transfer of developed protocols and downstream processes to internal and external manufacturing parties.
• Write various experimental reports, SOPs, batch records, technology transfer documents and participate in authoring relevant regulatory documents.
• Assist with and lead the production of nonclinical materials.
• Lead innovation, development and optimization of the Apic Bio upstream and downstream platform manufacturing process.
• Lead as point person for and maintain various external relationships with partners, vendors and CMOs/CROs.
• Interact/ high level of engagement leading Process Development group's IP, conference and publication strategy.

Skills and Requirements:

• Degree in biology, biochemistry, chemistry, biotechnology, or related field.
• PhD in a relevant subject matter, with a minimum of 4 years industry experience in AAV upstream and downstream process development.
• Extensive knowledge and experience with cloning and AAV production.
• Proficient with the use of AKTA and other chromatography systems, UF/DF systems, and cell filtration devices.
• Strong desire to learn multiple new techniques and willingness to work as part of and help lead a larger team.
• Significant attention to detail and accuracy in developing, reviewing and following protocols, SOPs, batch records and technology transfer documents.
• Ability to be highly productive in a fluid, fast-paced and teamwork-oriented environment.
• Prior experience with tech transferring to a cGMP facility is a must, prior experience working with external CMOs desired.
• Prior experience managing a team, co-ops or direct reports is desired.
• Collaborative and proactive attitude.
• Excellent written and oral communication skills.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Max Robinson at (+1) 929-388-1651 or upload your resume on our website - www.proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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