Scientist II- Analytical Development

Location: Greater Boston Area

Salary: $140,000- 150,000 benefits bonus

A small biotech local to the greater Boston area is developing a ground breaking vaccine that has the potential to revolutionize the way we approach infectious diseases. The technology behind this vaccine is innovative and has the potential to address a significant unmet medical need in the market. They are hiring across all verticals of CMC due to their promising programs in their current pipeline. They are seeking a Scientist II to join their Analytical Department- which would provide you with the opportunity to be at the forefront of cutting-edge research and make a meaningful impact with transferrable skills.

Responsibilities:

• Conduct analytical testing of drug substances and drug products using techniques such as HPLC, CE-SDS, SEC, and mass spectrometry.
• Develop and validate analytical methods to support characterization, release testing, and stability studies of vaccines.
• Perform data analysis and interpretation, generating technical reports and summaries to support regulatory submissions.
• Collaborate with cross-functional teams to troubleshoot and solve technical issues related to biologics development and manufacturing.
• Ensure compliance with regulatory guidelines (e.g., FDA, EMA) and internal quality standards throughout all analytical activities.
• Participate in technology transfer activities between analytical development and QC/QA groups.
• Investigate and implement new technologies and methodologies to improve analytical capabilities and efficiency testing.
• Train junior scientists and technicians on analytical techniques, methods, and best practices.
• Identifying, evaluating and qualifying potential partners for performance of GMP assays and extended characterizations.

Qualifications:

• PhD in Pharmaceutical Sciences or related field with 3-5 years of relevant experience in a pharmaceutical or biotechnology company, with a focus on analytical testing.
• A developed knowledge of cGMP practices aligning with analytical development, tech transfer, and method development.
• Experience with a variety of analytical techniques used in characterization and testing, such as HPLC, CE-SDS, SEC, mass spectrometry, ELISA, and others.
• Proficiency in method development, validation, and transfer for testing.
• Experience in data analysis, interpretation, and documentation, including preparing technical reports and regulatory submissions.
• Ability to troubleshoot analytical methods and instrumentation, and to solve technical problems independently.
• Excellent communication skills, both verbal and written, with the ability to present complex data and findings to diverse audiences.
• Experience in biopharmaceutical development, including early-stage research through late-stage development and commercialization.