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Analytical Development Biotech Jobs in Connecticut

Actalent

Research Associate

New Haven, CT

... and breakthrough biotechnology ? We're seeking a Research Associate - Spatial Genomics ... analysis and imaging. * Contribute to assay development, validation, and data generation using ...

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Analytical Development Biotech information

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 analytical development in the pharmaceutical industry?

Analytical development in the pharmaceutical industry involves creating and validating methods to accurately measure the quality, purity, and potency of drug substances and products. For an Analytical Development Biotech, this includes designing assays, optimizing analytical techniques like HPLC or mass spectrometry, and ensuring compliance with regulatory standards such as GMP and ICH guidelines.

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 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 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:
Analytical Development Biotech jobs near you
Infographic showing various Analytical Development Biotech job openings in Connecticut as of August 2026, with employment types broken down into 100% Full Time. Highlights an 100% In-person job distribution.

Scientist II, LC Development, Biologics Analytical Development

AstraZeneca

New Haven, CT • On-site

Full-time

Re-posted 27 days ago

AstraZeneca rating

8.4

Company rating: 8.4 out of 10

Based on 45 frontline employees who took The Breakroom Quiz

21st of 86 rated pharmaceutical

Job description

Are you ready to elevate chromatographic science to accelerate life-changing biologics for people with the greatest unmet need? In this role, you will develop and optimize robust LC methods that define product quality for complex therapeutic proteins, enabling confident decisions from early development through commercialization.
You will join a high-energy analytical development team that partners closely with Research & Development, Manufacturing, Quality Assurance and Quality Control. Your methods will drive release and stability strategies, resolve investigations, and strengthen regulatory submissions-turning scientific rigor into meaningful progress for patients. Could your next method power a pivotal study or unlock a critical root cause?
Accountabilities:
Chromatography Method Development:
  • Build, optimize, and phase-appropriately qualify custom (U)HPLC methods (SEC, RP, ion exchange, HIC) to monitor critical quality attributes for therapeutic proteins with a focus on fitness for purpose and lifecycle readiness.

Instrumentation Ownership:
  • Independently operate, maintain, and troubleshoot UPLC/HPLC systems and detectors (UV, FL, ELSD, CD) to increase reliability, throughput, and data integrity in a cGMP setting.

Method Qualification, Transfer, and Troubleshooting:
  • Plan and implement method qualification, validation, and transfer to internal and external laboratories; diagnose and resolve performance issues to ensure successful adoption and sustainable performance.

Analytical Testing and Investigations:
  • Perform phase-appropriate testing to support release and stability, contribute to characterizations and investigations, and translate findings into clear, actionable recommendations.

Technology Innovation:
  • Evaluate and implement new instruments, methods, and platforms to improve analytical capability and efficiency; introduce fit-for-purpose technologies that improve speed and insight.

Regulatory and Documentation Excellence:
  • Author SOPs, study plans, protocols, development reports, and draft content that supports regulatory submissions, ensuring clarity, traceability, and compliance.

Cross-Functional Collaboration:
  • Partner with R&D, Manufacturing, QA and QC to align analytical deliverables with program needs, enable process understanding, and support decision-making across development stages.

Scientific Leadership:
  • Stay current with evolving scientific principles and regulatory expectations; apply emerging knowledge to solve analytical problems and mentor standard methodologies within the team.

Essential Skills/Experience:
  • M.S. degree in Chemistry, Biochemistry, or a related biological science with 3+ years of relevant industry experience (or B.S. degree with 5+ years of experience)
  • Hands-on experience with (U)HPLC and practical knowledge of method development and optimization for protein therapeutics
  • Ability to take initiative in problem solving and apply an independent, scientific approach to method development and troubleshooting.
  • Ability to contribute technical content to regulatory submissions related to analytical sections.
  • Hands-on experience with LC systems from multiple vendors (e.g., Waters, Thermo Fisher), with strong proficiency in chromatography data systems (CDS) such as Empower and Chromeleon.
  • Experience developing and optimizing chromatographic methods for protein heterogeneity, aggregation, and degradation pathways.
  • Ability to organize and complete work independently with minimal direction.
  • Travel may be required on an as-needed basis to support training and troubleshooting.
  • Ability to work in a laboratory environment, including performing tasks with or without accommodation such as lifting/carrying materials, working with biological and hazardous materials, gowning/degowning PPE, and maintaining accurate laboratory documentation.
  • Compliance with cGXPs and maintenance of clear, accurate, and complete laboratory records with strong attention to detail

Desirable Skills/Experience:
  • Ph.D. with 1-3 years industry experience (particularly in CMC within pharmaceutical or biotech settings)
  • Experience with LC-MS-based protein characterization, including intact mass and peptide mapping using high-resolution MS platforms (e.g., Orbitrap, Q-TOF).
  • Experience independently generating procedures, protocols, and reports related to analytical test methods.
  • Strong working knowledge of current regulatory guidelines (e.g., ICH Q2 and Q14) and cGMP requirements
  • Strong analytical thinking skills, including problem solving and data interpretation.
  • High emotional intelligence with clear, professional communication skills
  • Ability to recognize aberrant test or sample conditions and propose scientifically sound corrective actions.

When we put unexpected teams in the same room, we spark ambitious thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of four days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and bold world!
Why AstraZeneca:
Join a science-led, mission-driven organization where advanced analytics and chromatography translate directly into patient impact. You will work at the intersection of cutting-edge platforms, rigorous quality standards, and real-world needs-combining the agility of a biotech with the reach of a global biopharma. We bring diverse experts together to tackle the hardest problems in biologics, equip teams with modern LC, LC-MS and digital tools, and value kindness alongside ambition so ideas become medicines faster and smarter. Your craft will scale beyond the bench to help people with severe, underserved conditions live fuller lives.
If you are ready to shape high-performance LC methods that accelerate transformative biologics to patients, step forward and make your impact with us today.
Date Posted
23-Jun-2026
Closing Date
20-Jul-2026
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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