AstraZeneca

Development Scientist II, Analytical Development and Clinical QC (ADQC)

AstraZeneca • $90K — $120K *
New Haven, CT 06511In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Reposted Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • M.S. or Ph.D. in Biochemistry, Chemistry, or related field.
  • 2-5 years (Ph.D.) or 10+ years (M.S.) of biological analytical development experience in the pharmaceutical industry.
  • Strong knowledge of cGMP, FDA regulations, and familiarity with ICH and EU guidelines.
  • Excellent analytical and problem-solving skills with experience in risk assessments and root cause analysis.
  • Proficiency in MS Word, Excel, and PowerPoint.

Responsibilities

  • Generate and review LIRs, driving ownership for investigating OOS, OOT, and atypical results.
  • Design investigational testing plans for compliant investigation closures.
  • Lead cross-functional meetings to ensure investigation alignment with quality assurance.
  • Create and track plans to achieve established targets, goals, and objectives.
  • Review analytical data to confirm expected assay performance.
  • Identify system improvement opportunities and recommend changes for compliance.

Benefits

  • Opportunity to work in a key team role within a leading biotech company.
  • Engagement with external contract laboratories, enhancing collaboration skills.
  • Development of skills in quality management and compliance systems.
  • Potential travel opportunities for professional development.
  • Inclusive workplace culture promoting equal employment opportunities.
Full Job Description
This is what you will do:

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.

You will be responsible for:

  • Responsible for generating and/or mirroring, reviewing, providing assessments, and driving ownership of LIRs to close out Out-of-Specification (OOS), Out-of-Trend (OOT), and atypical results with structured root cause analysis, impact assessment, and/or corrective/preventive actions (CAPAs).


  • Design investigational testing plans ensuring compliant closure of all testing related investigations within the quality system.


  • Lead and/or facilitate cross-functional meetings with quality assurance to ensure structured investigation alignment.


  • Create plans, track, and present timelines to meet established targets, goals, and objectives.


  • Perform review of analytical data to ensure expected assay performance.


  • Identify opportunities for improvement in systems and make recommendations for effective changes to ensure compliance with cGMP.


  • Strong presentation skills


You will need to have:

  • A 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.


We would prefer you to have:

  • Working knowledge in validated documentation systems: Veeva Vault (EQV), LIMS, ValGenesis, 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.


Date Posted
18-Jun-2026

Closing Date
25-Jun-2026

About AstraZeneca

AstraZeneca is a British-Swedish multinational pharmaceutical company that specializes in the research, development, and manufacturing of prescription drugs. The company was formed in 1999 through the merger of Astra AB and Zeneca Group plc. AstraZeneca's products are used to treat a wide range of medical conditions, including cancer, cardiovascular disease, respiratory disease, and diabetes. The company has operations in over 100 countries and employs more than 76,000 people worldwide. AstraZeneca is committed to developing innovative medicines that improve the health and well-being of people around the world.
Learn more about AstraZeneca
Size
83,100 employees
Market Cap
$211.5 billion
Industry
Pharmaceuticals & Biotech
Net Income
$3.1 billion
Founded
1999
5 Year Trend
+10.2%
Revenue
$26.6 billion
NASDAQ
AZN
* Ladders Estimates

Similar Jobs

Ad banner background

Get Ready For Your
Next Interview

More Jobs at AstraZeneca

More Pharmaceuticals & Biotech Jobs

Find similar Development Scientist II, Analytical Development and Clinical QC (ADQC) jobs:

NationwideNew Haven, CT