Senior Scientist, Process Analytics

Altimmune (NASDAQ: ALT) is a late clinical-stage biopharmaceutical company developing therapies for patients with serious liver diseases. The Company's lead candidate, pemvidutide, is a unique dual-action therapy targeting both glucagon and GLP-1 receptors in a balanced 1:1 ratio in development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), alcohol use disorder (AUD), and alcohol-associated liver disease (ALD). For more information, please visit www.altimmune.com.

Job Description: The Senior Scientist, Process Analytics, will lead the strategy and process analytics for Drug Substance (DS) with support to Drug Product (DP). The role owns design, development, validation, and tech transfer of analytical methods and control strategies, translating data into actionable process understanding and control. This role will report to the Senior Director, Drug Substance Development.

Essential Functions:

• Serve as analytical and PAT lead; translate process needs into phase‑appropriate analytical and control strategies
• Lead DS analytical method lifecycle: development, validation, and transfer
• Provide technical leadership for tech transfer to CDMOs, including analytical sections and comparability
• Develop and implement QbD‑based control strategies for process validation
• Design and execute DS purification development/optimization studies
• Build assay trend reports, longitudinal analysis, statistical process control, and multivariate monitoring to support PPQ readiness and continued process verification
• Support DS manufacturing campaigns and product quality events
• Partner cross-functionally (DP, Quality, Regulatory, CDMOs) for analytical support
• Support analytical comparability, DP stability, and lifecycle activities
• Author regulatory documents and contribute to CMC filings
• Serve as SME and mentor junior scientists.

 

Job Requirements (essential knowledge, skills, and attributes):

• PhD with 5+ yrs, MS with 8+ yrs, or BS with 10+ yrs relevant experience
• Strong analytical and problem‑solving skills
• Extensive experience with method validation, QbD, CPP/CQA, DoE, and statistical tools
• Excellent communication and collaboration skills.

Preferred Qualifications (knowledge, skills, and attributes)

• Experience with therapeutic peptides and peptide API purification
• Experience with PAT, spectroscopic tools, and multivariate models
• Experience authoring CMC sections and supporting Health Authority interactions
• Familiarity with ICH Q1, Q2, Q14, Q8–Q12, Q11 and cGMP.

Altimmune provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.