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Analytical Development Biotech Jobs in Washington

Guidehouse

Bioassay Researcher

Silver Spring, MD

$85K - $141K/yr

Establish new analytical methods to evaluate the biological activity of biotechnology products ... Understanding of biopharmaceutical manufacturing, process development, biotechnology research and ...

Guidehouse

Bioassay Researcher

Silver Spring, MD · On-site

$85K - $141K/yr

Establish new analytical methods to evaluate the biological activity of biotechnology products ... Understanding of biopharmaceutical manufacturing, process development, biotechnology research and ...

Genomics Ltd

Business Development Lead

Triangle, VA · On-site

... analytics to accelerate drug discovery and advance predictive, preventative healthcare. We are ... You'll identify, qualify, develop, and close opportunities across pharma and biotech - connecting ...

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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 Washington?

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

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

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

Analytical Development Biotech jobs near you

Associate Director, Projects & Strategy, Analytical Sciences & Technology (AS&T)

Gaithersburg, MD • On-site

Scorpion Therapeutics
51 - 200 employees
Learn more about Scorpion Therapeuticsexternal

$146 - $234/hr

Other

This job post has expired today. Applications are no longer accepted.

Job description

Responsibilities
  • Represent the analytical function within cross-functional project teams and act as the primary interface for the CMC team and other key stakeholders.
  • Coordinate analytical deliverables across internal analytical functions and external partners, ensuring alignment with the overall analytical development strategy.
  • Shape and align the analytical control strategy with Regulatory Affairs, CMC, and Quality to ensure compliance with regulatory expectations and health authority requirements.
  • Provide leadership and oversight for analytical activities, communicating progress, timelines, risks, and challenges.
  • Maintain end-to-end ownership of the analytical components of the CMC Module 3 dossier, including document preparation, review, and lifecycle maintenance.
Qualifications
  • Advanced degree in Biology, Chemistry, Pharmacy, Biotechnology, or related field; plus 10+ years’ experience in a regulated pharmaceutical environment.
  • Broad experience in analytical functions (AS&T, Quality Control, or Analytical Development) focused on mAbs, multi-specific antibodies, and/or ADCs.
  • Strong late-stage analytical development and commercial support experience for antibody-based products (ideally ADCs).
  • Demonstrated leadership and analytical project management experience.
  • Deep understanding of US/EU regulatory frameworks (EMA, FDA), CMC analytical development documentation, GMP, and compendial standards (USP, Ph. Eur.).
  • Strong organizational, communication, stakeholder management, and intercultural cross-functional skills.
  • Pre-approval support experience (e.g., PLI readiness, BLA preparation, product launch) is an advantage.

Your benefits and remuneration (as stated): Expected pay range $146,300/year to $234,100/year + benefits, annual bonus & equity.

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