Development Scientist I, Analytical Development & Clinical Quality Control New Haven, CT

$107,000 - $160,000/Yr

Alexion Pharmaceuticals - New Haven, CT

Full-time - Mid Level

New Haven, CT

1-10 employees

Chemical Manufacturing

About the position

The Development Scientist I position in Analytical Development & Clinical Quality Control at Alexion Pharmaceuticals involves performing characterization of biotherapeutics from research to commercial products. The role requires expertise in various analytical techniques and the ability to manage projects independently while collaborating with cross-functional teams. The candidate will be responsible for leading studies, authoring regulatory documents, and developing innovative characterization strategies.

Responsibilities

• Perform characterization of biotherapeutics from research to commercial products.
• Lead and perform comparability and forced degradation studies.
• Conduct protein variant enrichment, fractionation, and characterization.
• Participate in cross-functional development teams and lead scientific problem-solving efforts.
• Author CMC sections for regulatory and technical reports, protocols, and operating procedures.
• Develop and author new procedures and work practices.
• Evaluate innovative technologies and develop protein characterization strategies.
• Conduct experimental studies to optimize analytical methods for biotherapeutic candidates.

Requirements

• Doctoral degree in Biochemistry, Chemistry, or related scientific subject.
• Direct experience with analytical techniques such as HPLC/UPLC, CE-SDS, and icIEF.
• Good understanding of protein characterization and comparability studies.
• Ability to independently generate procedures, protocols, and reports.
• Strong organizational, writing, and presentation skills.
• Experience in a laboratory environment with GLP and quality guidelines.

Nice-to-haves

• BS Degree with 7+ years of experience or MS Degree with 5+ years of experience or PhD with 0+ years of experience in Biochemistry or Chemistry.
• Some knowledge of MS methods and instrumentation for testing biotherapeutics.
• Experience with assay development, optimization, qualification, and validation for biotherapeutics.

Benefits

• Paid holidays
• Health insurance
• Dental insurance
• 401(k)
• Vision insurance