Purification & Analytics Scientist

System One; Cambridge (MA); On-site; USD 99,000 - 135,000; Full time

Job summary

System One is seeking a Purification & Analytics Scientist for an onsite contract-to-hire role in Boston, MA. You will lead RNA purification and the analytical strategy used to determine batch release.

The position requires a PhD or MS with equivalent experience in analytical chemistry, biochemistry, or bioprocess engineering and a minimum of five years in biologics or nucleic-acid purification and analytical development. This is a demanding role in a growing U.S. biotech organization.

Qualifications

• PhD or MS in analytical chemistry, biochemistry, or bioprocess engineering.
• Minimum of five years of experience in biologics or nucleic-acid purification and analytical development.

Responsibilities

• Lead specialist in RNA purification and analytical strategy to determine batch release
• Manage purification unit operations: tangential flow filtration, membrane or chromatographic purification, including double-stranded RNA removal below 1% w/w and residual DNA below 10 ng/mg
• Develop and maintain the product quality attribute list per modality, mapped to quality-control measurement domains
• Define analytical target profiles for each attribute according to ICH Q2(R2) and Q14, including accuracy, precision, range, and specificity
• Rank and prioritize in-line, at-line, and off-line analytical technologies against established profiles with documented criteria

Education

PhD or MS in analytical chemistry, biochemistry, or bioprocess engineering

Job description

Job Title: Purification & Analytics Scientist
Location: Boston, MA
Type: Contract to Hire
Compensation: $84.13
Work Model: Onsite
Hours: Standard business hours
Security Clearance: Not specified

Overview:
Join a growing U.S. biotechnology organization specializing in RNA medicine manufacturing. You'll be provide the specialist leadership on RNA purification and on the analytical strategy that determines whether a batch can be released.

Responsibilities

• Lead specialist in RNA purification and analytical strategy to determine batch release
• Manage purification unit operations: tangential flow filtration, membrane or chromatographic purification, including double-stranded RNA removal below 1% w/w and residual DNA below 10 ng/mg
• Develop and maintain the product quality attribute list per modality, mapped to quality-control measurement domains
• Define analytical target profiles for each attribute according to ICH Q2(R2) and Q14, including accuracy, precision, range, and specificity
• Rank and prioritize in-line, at-line, and off-line analytical technologies against established profiles with documented criteria

Requirements

• PhD or MS with equivalent experience in analytical chemistry, biochemistry, or bioprocess engineering
• Minimum of five years of experience in biologics or nucleic-acid purification and analytical development
• Ability to cover both purification process expertise and analytical expertise; candidates strong in only one area will leave a gap

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

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