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

Socket.dev; New Haven (CT); On-site; USD 95,000 - 125,000; Full time

Job summary

AstraZeneca, in its External Analytical Development and Quality Control group, seeks a Development Scientist II to maintain high quality in external QC testing and lead laboratory investigations with external labs. You will drive timely LIR closures and coordinate with QA, Analytical Development, and Stability teams to ensure compliant release of CoAs.

Ideal candidates possess advanced degrees in Biochemistry or Chemistry with substantial hands-on experience in pharmaceutical analytics and

Qualifications

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

Responsibilities

• Generate and own LIRs to close OOS/OOT with root cause analysis and CAPAs
• Design investigational testing plans for compliant closure
• Lead cross-functional meetings with quality assurance for investigation alignment
• Create plans, track timelines and present targets
• Review analytical data to ensure assay performance
• Identify opportunities for system improvements to ensure cGMP compliance
• Demonstrate strong presentation skills

Skills

Analytical thinking

Problem-solving

Cross-functional collaboration

MS Office

Communication skills

Travel up to 10%

Education

MS in Biochemistry/Chemistry

PhD in Biochemistry/Chemistry

Tools

Veeva Vault (EQV)

LIMS

Val Genesis

Kneat

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, 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 mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.