Alexion Pharmaceuticals - New Haven, CT
posted 22 days ago
Full-time - Entry Level
New Haven, CT
Chemical Manufacturing
About the position
The Development Scientist I position in Analytical Development & Clinical Quality Control focuses on the characterization of biotherapeutics, including antibodies, proteins, and peptides. The role involves utilizing various analytical techniques to ensure product quality from research through to commercial stages. The candidate will work collaboratively with multiple departments and is expected to manage projects independently while also training junior scientists.
Responsibilities
- Perform characterization of biotherapeutics from research to commercial products.
- Lead and perform comparability and forced degradation studies.
- Lead and perform 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
- Familiarity with investigating PTMs and other protein properties using analytical assays.
- Direct experience with analytical techniques such as HPLC/UPLC, CE-SDS, icIEF, and fraction collection.
- Good understanding and direct experience with protein characterization.
- Understanding of comparability and forced degradation studies.
- Knowledge of CQA assessments.
- Ability to take initiative in problem solving and method development.
- Thorough understanding of GLP and quality guidelines.
- Ability to give clear instructions and train personnel in laboratory practices.
- Strong planning and organizing skills to manage laboratory commitments.
Nice-to-haves
- BS Degree with 7+ years of experience, MS Degree with 5+ years of experience, or PhD with 0+ years of experience in Biochemistry, Chemistry, or related field.
- Some knowledge of MS methods and instrumentation for testing biotherapeutics.
- Experience with assay development, optimization, qualification, and validation for biotherapeutics.
Benefits
- 401(k) plan
- Paid vacation and holidays
- Paid leaves
- Health benefits including medical, prescription drug, dental, and vision coverage
