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Analytical Development Biotech Jobs in Connecticut

Participate in planning, design, execution, analysis of experiments and formal risk assessments to ... Biotechnology, Mathematics, Molecular Biology, Pharmaceutical Science, Statistics, or a related ...

$20 - $60/hr

Participate in planning, design, execution, analysis of experiments and formal risk assessments to ... Biotechnology, Mathematics, Molecular Biology, Pharmaceutical Science, Statistics, or a related ...

Participate in planning, design, execution, analysis of experiments and formal risk assessments to ... Biotechnology, Mathematics, Molecular Biology, Pharmaceutical Science, Statistics, or a related ...

Participate in planning, design, execution, analysis of experiments and formal risk assessments to ... Biotechnology, Mathematics, Molecular Biology, Pharmaceutical Science, Statistics, or a related ...

Participate in planning, design, execution, analysis of experiments and formal risk assessments to ... Biotechnology, Mathematics, Molecular Biology, Pharmaceutical Science, Statistics, or a related ...

Participate in planning, design, execution, analysis of experiments and formal risk assessments to ... Biotechnology, Mathematics, Molecular Biology, Pharmaceutical Science, Statistics, or a related ...

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Analytical Development Biotech information

What is analytical development in biotech?

Analytical Development in biotech refers to the process of designing, developing, and validating methods to analyze biological products, such as proteins, antibodies, or cell therapies, during various stages of drug development and manufacturing. These methods are essential for ensuring the safety, quality, potency, and purity of biotechnological products. Professionals in this field work closely with research, production, and regulatory teams to ensure that analytical methods meet industry standards and comply with regulatory requirements. Analytical Development is a critical part of bringing new biopharmaceutical products from the lab to the market.

What are the key skills and qualifications needed to thrive as an analytical development biotech professional?

To thrive as an Analytical Development Biotech professional, you need a strong background in analytical chemistry, biochemistry, or a related field, typically supported by at least a bachelor's or master's degree. Familiarity with analytical instrumentation such as HPLC, GC, mass spectrometry, and relevant quality systems like GMP or ICH guidelines is crucial. Strong problem-solving, attention to detail, and effective communication are important soft skills for collaborating across multidisciplinary teams. These competencies ensure accurate data generation, regulatory compliance, and successful development of biotechnological products.

What are some typical challenges faced by analytical development professionals in the biotech industry?

Analytical Development professionals in biotech often encounter challenges such as developing robust methods for novel biologics, ensuring regulatory compliance, and adapting to rapid technological changes. They frequently work within cross-functional teams, collaborating closely with research, manufacturing, and quality assurance groups to optimize assay performance and troubleshoot issues. Staying current with evolving regulatory standards and balancing project timelines with method validation requirements are also common aspects of the role.

What is the difference between Analytical Development Biotech vs Quality Control Analyst?

AspectAnalytical Development BiotechQuality Control Analyst
CredentialsBachelor's/Master's in Life Sciences, Chemistry, or related fieldsBachelor's in Chemistry, Biology, or related fields; often requires GMP training
Work EnvironmentResearch labs, development departments, collaborative teamsQuality labs, manufacturing facilities, compliance-focused settings
Industry UsageDeveloping and optimizing analytical methods for biotech productsTesting and ensuring product quality and compliance with standards

Analytical Development Biotech focuses on creating and refining analytical methods during product development, while Quality Control Analysts primarily test products to ensure they meet quality standards. Both roles require similar educational backgrounds and work in laboratory settings, but their core responsibilities differ in the product lifecycle.

What are popular job titles related to Analytical Development Biotech jobs in Connecticut?

For Analytical Development Biotech jobs in Connecticut, the most frequently searched job titles are:

What job categories do people searching Analytical Development Biotech jobs in Connecticut look for?

The top searched job categories for Analytical Development Biotech jobs in Connecticut are:

What cities in Connecticut are hiring for Analytical Development Biotech jobs?

Cities in Connecticut with the most Analytical Development Biotech job openings:

Infographic showing various Analytical Development Biotech job openings in Connecticut as of September 2026, with employment types broken down into 1% Internship, 1% As Needed, 84% Full Time, 12% Part Time, and 2% Contract. Highlights an 86% Physical, 2% Hybrid, and 12% Remote job distribution.

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

New Haven, CT • On-site

Socket.dev
Network Security • 1 - 10 employees

Other

Posted 25 days ago


Key responsibilities

  • Initiate, review, and drive ownership of laboratory investigations related to Out-of-Specification, Out-of-Trend, and atypical results, including root cause analysis and CAPAs.

  • Design and ensure the timely, compliant closure of testing investigations within the quality system, including tracking and presenting progress to meet targets.

  • Review analytical data to ensure assay performance and collaborate with cross-functional teams to improve systems and ensure compliance with cGMP.


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.

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