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Company

Original Job Post

BioSpace · 2 days ago

Process Development Associate Scientist

Cambridge, MA

Full-time

Hybrid

Entry, Mid Level

2+ years exp

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Comp. & Benefits

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Responsibilities

Work in a cross-functional team environment to advance therapies in late-stage development.

Analyze late-stage protein-based therapies with advanced analytical techniques such as capillary electrophoresis, liquid chromatography, mass spectrometry, as well as other methods such as Ellmans assay, etc.

Support the development, optimization, and troubleshooting of analytical methods, participate in qualifications, transfer, and validation experiments with focus on separation-based purity methods.

Other duties include data analysis, preparation of electronic notebook records of experimental data, authorship of technical protocols and reports, presentation of results at team meeting, and support for regulatory filings as needed.

Expert level experience troubleshooting, and maintaining HPLC/UPLC instruments.

Expertise in the use of Empower software (e.g., custom field creation, writing instrument methods, etc.)

Qualification

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Laboratory skillsAnalytical methodologiesData analysis softwareTask managementTroubleshootingInstrument maintenanceElectronic notebooksMethod qualificationsGMP complianceProblem-solvingHard-workingCollaborationCommunication

Required

Bachelors degree and 3 years of Scientific experience OR

Masters degree and 1 year of Scientific experience

Degree in chemistry, biochemistry, pharmaceutical sciences, or related field.

Excellent laboratory skills with 2+ years of experience in industry laboratories supporting analysis and characterization of protein therapies.

Advanced technical expertise in analytical methodologies used to characterize protein therapeutics including CE-SDS, cIEF / icIEF, HIC, SEC, IEX, RP, HILIC, MS, etc.

Experience using CE and LC operation and data analysis software.

Working knowledge of data processing and statistical analysis software tools.

Ability to independently prioritize, schedule, and manage multiple tasks in order to meet deliverables.

Ability to work in a matrix team environment and collaborate effectively.

Excellent written and oral communication skills.

Experience troubleshooting and maintaining laboratory instruments and training others on the use of instruments.

Experience with use of electronic notebooks.

Hands on experience with method qualifications and transfers.

Understanding of phase-appropriate GMP compliance and documentation.

Benefits

Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.

A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan

Stock-based long-term incentives

Award-winning time-off plans and bi-annual company-wide shutdowns

Flexible work models, including remote work arrangements, where possible