Senior Scientist I/II, Biologics ARD

Role Summary

The candidate will focus on development and implementation of analytical assays for the analysis of complex biologics including antibodies, antibody drug conjugates, and new modalities. The candidate will use and develop a variety of analytical techniques including chromatography, electrophoresis, spectroscopy, and automated methods. The successful candidate will contribute to the development and testing of complex and automated assays and will contribute to the continuous improvement and innovation within the group.

Responsibilities

• Effectively function as a scientist, generating original technical ideas and research or development strategies.
• Demonstrate the ability to resolve key project hurdles and assumptions by effectively utilizing available information and technical expertise.
• Independently responsible for project science within his/her area of expertise on one or more project teams leading the method development and validation for complex biologic therapeutics.
• Proactively seek out new information in the literature and incorporate this into individual projects as well as the overall program.
• Work in partnership with colleagues from Discovery, Process Chemistry/Engineering Formulation Development, and Characterization departments, among others.

Qualifications

• Compensation/leveling will be commensurate to experience.
• • Senior Scientist I: Ph.D. with 0-4 years of relevant experience required or MS with 8+ years of experience, highly preferred. Bachelor’s Degree with 10+ years of relevant experience.
  • Senior Scientist II: Ph.D. with 4+ years of relevant experience required or MS with 10+ years of experience, highly preferred. Bachelor’s Degree with 12+ years of relevant experience.
• Practical experience and strong knowledge in one or more of the following areas: protein/oligonucleotide HPLC, capillary electrophoresis, MALS, automation and/or spectroscopy for biologics.
• Previous cGMP or GLP experience and attention to detail in documentation.
• Demonstrated record of independent thought, creativity and scientific accomplishment (e.g. peer reviewed journal publications, patents).
• Must have a solid understanding of protein/oligonucleotide chemistry and biochemistry, particularly as related to biologics drug development.
• Strong data and time organization/management skills coupled with strong interpersonal and effective communication skills for facilitating collaborations with a demonstrated ability to lead cross functional process development teams.
• Effective writer and communication of research or other regulatory materials.
• Experience with analytical Multivariate Analytical Procedures development and/or validation a plus.

Education

• Ph.D. with relevant experience preferred or MS with substantial relevant experience; Bachelor’s Degree with substantial relevant experience may be considered for certain levels.