Development Scientist II, Analytical Development and Clinical QC; ADQC) Haven, Connecticut

## Development Scientist II, Analytical Development and Clinical QC (ADQC)
New Haven, Connecticut, United States of America This Development Scientist II will be a key team member in Alexion's External Analytical Development and Quality Control group. This position is responsible for maintaining the highest standard of quality and compliance of external quality control testing (GMP) laboratories. This candidate will be responsible for initiation and ownership of laboratory investigations (LIRs) through strong liaison with external contract laboratories and change controls relevant to ADQC biologic programs.

The candidate will ensure timely, compliant, and high-quality delivery for LIR closure to enable the generation of final release CoAs. The role will work closely with internal Quality Assurance, Compliance, Analytical Development and Stability teams to ensure product to patients.

Strong presentation skillsA successful candidate will have strong mental acuity with high attention to detail and ability to maintain accuracy in documentation and processes.

Excellent analytical and problem-solving skills with the ability to conduct risk assessments and root cause analysis.

A broad knowledge of Pharmaceutical Quality Assurance, regulatory compliance, and/or quality control inclusive of cGMP, FDA regulations, familiarity with ICH guidelines and EU regulations. Strong proficiency in quality management systems and effective communication skills for interacting with cross-functional teams. Strong proficiency with MS Word, Excel, PowerPoint. Ability to bend, reach and stand, with lifting to 15 pounds and carrying over short distances.

Ability to travel up to 10%, if needed.

Advanced (M.S. or Ph.D.) degree in Biochemistry, Chemistry or related discipline with 2-5 years (Ph.D.) or 10+ (M.S.) hands on biological analytical development experience in pharmaceutical industry.

Working knowledge in validated documentation systems:
Veeva Vault (EQV), LIMS, Val Genesis, Kneat, etc.

Knowledge of pharmaceutical/biotechnology manufacturing process

Database management /statistical analysis (e.g., JMP, Tableau, SAS) with proficiency in Microsoft SharePoint and/or BOX.Our Philosophy At Alexion, we change lives every day. People living with rare and devastating diseases are our guiding star. We believe it is our responsibility to listen to, understand and change the lives of patients and those who work tirelessly to help them. We continue to deepen our understanding of rare disease, which began with our pioneering work in complement biology.

This knowledge allows us to innovate and evolve into new areas, where there is great unmet need and opportunity to help patients and families fully live their best lives.

Top skills

Assay Development Cell Culture Cell Therapy Biochemistry Flow  Cytometry

BiologyELISAMicroscopy

Drug Discovery Process