Top 3 Senior analytical chemist Jobs in Frederick Md

Senior Scientist
Talnt —Gaithersburg, MD
- $130,000 - $175,000 a year
- Full-time
- Bachelor of Science
- Analysis skills
- Bachelor's degree
Quick Apply
Senior Bioanalytical Associate
Meso Scale Diagnostics, LLC. —Gaithersburg, MD
- $67,900 - $101,000 a year
- Mid-level
- Master's degree
- Bachelor's degree
- Paid parental leave
- AD&D insurance
Quick Apply
Sr. Research Associate, Mass Spectrometry (#1901)
Battelle National Biodefense Inst —Fort Detrick, MD
- $64,539.85 - $106,631.06 a year
- Full-time
- Bachelor of Science
- Master's degree
- Analysis skills
Quick Apply

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Senior Scientist

Talnt
Gaithersburg, MD

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Job Details

Full-time
$130,000 - $175,000 a year

Qualifications

Stability testing
Production data analysis
Stability studies in drug product development
Quality control statistical data analysis
Design of experiments
Statistical Process Control
Drug regulation
GMP
Production validation processes
Pharmaceutical company experience
Technology transfer (scale-up process)
Pharmaceutical analysis
Chemistry, manufacturing & controls
Quality control experience within pharmaceutical industry
Cross-functional communication
Statistical analysis tools
Pharmaceutical manufacturing facility experience

Full Job Description

About the Role:
The Senior Scientist, Process Analytics, Drug Substance, is a key technical leadership role focused on analytical development, process analytical technology, and control strategy design within a clinical-stage biopharmaceutical environment. This position supports drug substance and drug product development, driving analytical method lifecycle management, process understanding, and regulatory readiness. Common search terms for this role include Senior Scientist Process Analytics, Analytical Development Scientist, Drug Substance Scientist, PAT Scientist, and CMC Analytical Lead.

Responsibilities:

Lead analytical and process analytical technology strategy, translating process development needs into phase-appropriate analytical methods and control strategies
Own the full lifecycle of drug substance analytical methods, including development, validation, qualification, and technology transfer to manufacturing partners
Provide technical leadership for tech transfer activities to CDMOs, including analytical comparability and method transfer documentation
Develop and implement Quality by Design based control strategies, including identification of critical process parameters and critical quality attributes
Design and execute purification process development and optimization studies for drug substance manufacturing
Perform statistical data analysis, including design of experiments, multivariate analysis, and statistical process control to support process validation and continued process verification
Generate analytical trend reports and support process performance qualification readiness
Support manufacturing campaigns, investigations, and product quality events with data-driven insights
Collaborate cross-functionally with drug product, quality, regulatory, and external partners to ensure alignment on analytical strategies
Author and review regulatory documentation, including CMC sections, and support health authority submissions and interactions
Serve as a subject matter expert in analytical development and mentor junior scientists

Qualifications:

PhD with 5 or more years, MS with 8 or more years, or BS with 10 or more years of experience in analytical development, process analytics, or biopharmaceutical development
Strong expertise in analytical method development, validation, and lifecycle management in a cGMP environment
Deep knowledge of Quality by Design principles, including CPPs, CQAs, and control strategy development
Experience with statistical tools such as design of experiments, data trending, and multivariate analysis
Proven experience supporting technology transfer, analytical comparability, and manufacturing scale-up
Strong understanding of regulatory expectations for CMC documentation and analytical methods
Excellent problem-solving, communication, and cross-functional collaboration skills

Desired Qualifications:

Experience with therapeutic peptides, peptide API development, or purification processes
Hands-on experience with process analytical technology tools, spectroscopy, and real-time monitoring systems
Experience authoring CMC sections and supporting regulatory submissions and health authority interactions
Familiarity with ICH guidelines, including Q1, Q2, Q8 through Q12, Q11, and current good manufacturing practices
Experience supporting drug product stability programs and lifecycle management activities

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senior analytical chemist jobs in frederick md

Senior Scientist

Senior Bioanalytical Associate

Sr. Research Associate, Mass Spectrometry (#1901)

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