ZipRecruiter

Log In

1

Analytical Development Biologics Jobs (NOW HIRING)

next page

Showing results 1-20

People also search for

All JobsAnalytical Development Biologics Jobs

Analytical Development Biologics information

See salary details

$18

$26

$38

How much do analytical development biologics jobs pay per hour?

As of May 31, 2026, the average hourly pay for analytical development biologics in the United States is $26.49, according to ZipRecruiter salary data. Most workers in this role earn between $23.08 and $28.85 per hour, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as an Analytical Development Biologics professional, and why are they important?

To thrive as an Analytical Development Biologics professional, you need a strong background in biochemistry, molecular biology, and analytical chemistry, often supported by an advanced degree in a relevant scientific field. Familiarity with analytical techniques such as HPLC, mass spectrometry, ELISA, and regulatory standards like GMP is typically required. Attention to detail, problem-solving abilities, and effective teamwork are crucial soft skills in this role. These competencies are essential for ensuring accurate biologics characterization, regulatory compliance, and the successful development of safe and effective biopharmaceutical products.

What are some common challenges faced by Analytical Development Biologics professionals when transitioning from research to process development?

One common challenge for Analytical Development Biologics professionals is adapting analytical methods developed in a research environment for robust use in process development and manufacturing settings. This often requires optimizing assays for greater reproducibility, scalability, and regulatory compliance. Additionally, collaboration with cross-functional teams such as process engineers and quality assurance is essential to ensure methods meet both scientific and operational requirements. Balancing innovation with the need for validated, standardized procedures can be demanding but is crucial for successful biologics development.

What is Analytical Development in Biologics?

Analytical Development in Biologics refers to the process of designing, optimizing, and validating analytical methods to characterize and ensure the quality, safety, and efficacy of biologic drugs, such as proteins, antibodies, and vaccines. Professionals in this field develop assays to analyze biological samples, monitor production processes, and support regulatory submissions. Their work is crucial throughout drug development, from early research to commercial production, ensuring products meet strict regulatory standards.

What is the difference between Analytical Development Biologics vs Analytical Development Chemist?

AspectAnalytical Development BiologicsAnalytical Development Chemist
CredentialsBachelor's or Master's in Life Sciences, Biochemistry, or related fields; relevant certificationsBachelor's or Master's in Chemistry, Biochemistry, or related fields; relevant certifications
Work EnvironmentPharmaceutical or biotech labs focused on biologics; working with proteins, antibodies, and cell-based productsLabs working on small molecules, chemicals, and drug compounds; analytical testing and method development
Industry UsagePrimarily in biologics and biotech companiesIn pharmaceutical, chemical, and research organizations

Analytical Development Biologics and Analytical Development Chemist roles share similar skills in analytical techniques but differ mainly in the type of products they focus on. Biologics roles emphasize working with complex biological molecules, while chemist roles focus on small molecules. Both positions require strong analytical skills and relevant scientific backgrounds, but their specific expertise and work environments vary significantly.

What are the most commonly searched types of Analytical Development Biologics jobs? The most popular types of Analytical Development Biologics jobs are:
What states have the most Analytical Development Biologics jobs? States with the most job openings for Analytical Development Biologics jobs include:
Analytical Development Biologics jobs near you
Director of Analytical Development (Late Stage), Biologics

Director of Analytical Development (Late Stage), Biologics

EPM Scientific

Boston, MA • Remote

Full-time

Posted 15 days ago

Job description

Director of Analytical Development, Biologics

REMOTE - East Coast Based Preferred

Overview

We are partnering with a clinical-stage (late-stage) biopharmaceutical organization seeking a Director of Analytical Development to lead analytical strategy and execution for biologics programs advancing through late-stage development, BLA readiness, and commercialization.

This individual will play a critical role in method lifecycle management, regulatory submissions, and commercial readiness, working cross-functionally across CMC, Quality, and Regulatory.

This is a fully remote role (U.S.-based).

Key Responsibilities

  • Lead analytical development strategy for late-stage biologics programs, including Phase II/III and commercial readiness
  • Oversee method validation, transfer, and lifecycle management in alignment with ICH guidelines (Q2, Q6, Q14)
  • Drive analytical support for regulatory submissions, including IND amendments, BLA/MAA filings, and responses to health authority questions
  • Partner with Drug Substance, Drug Product, and Quality teams to ensure robust control strategies and specifications
  • Provide oversight of CDMOs and external testing laboratories, ensuring timelines, data quality, and compliance
  • Support comparability, stability, and characterization strategies for process changes and scale-up
  • Act as a key contributor during inspections and audits (FDA, EMA, etc.)
  • Build, mentor, and scale a high-performing analytical team as programs advance toward commercialization

Qualifications

  • PhD (preferred) or MS in Analytical Chemistry, Biochemistry, or related field
  • ~10-15+ years of analytical development experience in biologics (monoclonal antibodies, proteins, or related modalities)
  • Strong expertise in late-stage development, method validation, and regulatory filings (BLA/MAA)
  • Deep knowledge of analytical techniques (e.g., HPLC/UPLC, CE, MS, bioassays, impurity profiling)
  • Proven experience managing external partners (CDMOs/CROs)
  • Familiarity with global regulatory expectations and inspection readiness
  • Prior leadership experience with the ability to influence cross-functional stakeholders

What Stands Out

  • Opportunity to shape analytical strategy at a pivotal, late-stage inflection point
  • High visibility role with direct impact on regulatory approval and commercialization
  • Fully remote flexibility with strong cross-functional exposure

Company Description

A top 10 pharmaceutical company with an immense amount of growth after releasing their at home COVID diagnostic tests is looking to bring on 200+ Quality Individuals through a massive hiring campaign. In their search for Quality Specialists, the organization is looking for individuals who will be responsible for reviewing and actioning customer complaints, as well as investigation into said complaints.
Job Responsibilities:
• Conducting Post Market Activities and Post Market Surveillance
• Managing Customer and Product Complaint Investigation programs
Education and Experience:
• 1 YR. of experience in a technical role in the medical device/pharma/biotech industry
• Bachelor's degree
• Computer proficiency