The Applied AI Scientist — R&D and Regulatory builds and deploys AI systems that accelerate product development and regulatory submissions. The role applies natural language processing, document intelligence, and generative AI to Amneal's scientific and regulatory content, delivering validated systems that meet GxP and 21 CFR Part 11 requirements and are defensible under health authority inspection. The role sits within the Enterprise AI Transformation function, working in close partnership with Regulatory Affairs and R&D.
Essential Functions:
Regulatory & Scientific Agents
- Build models that analyze historical health authority correspondence — deficiency letters, information requests, and complete response letters — to identify recurring deficiency patterns and flag submission risk prior to filing.
- Develop retrieval and generation agentic systems over controlled scientific content including specifications, analytical methods, stability data, prior filings, and eCTD, with full traceability from output to source.
- Build AI-assisted drafting and comparison capability for product labeling, including structured product labeling content and reference listed drug comparison.
AI Solution Development
- Design and maintain formal evaluation frameworks for all generative systems, including curated golden datasets, defined failure taxonomies, and automated regression testing.
- Execute AI system validation under Amneal's GxP AI validation framework: risk classification, intended-use definition, qualification testing, and periodic review.
- Build and maintain production data pipelines on Databricks over unstructured scientific documents, including OCR, parsing, and entity extraction from legacy PDF sources.
Business Impact
- Establish benefit baselines with Regulatory and R&D functional owners and measure realized cycle-time and capacity outcomes.
- Present technical approaches, validation evidence, and model limitations to Regulatory, and R&D leadership.
- Enable larger organization and educate to upskill on usage and application of agentic systems.
Research and Portfolio Insights
- Develop literature, patent, and prior-art mining capabilities supporting product development screening and portfolio prioritization.
Qualifications
Education:
- Bachelor's Degree (BA/BS) Computer Science, Computational Chemistry, Bioinformatics, Statistics or a related quantitative or scientific field, with equivalent demonstrated experience (Required)
- Master's Degree (MS/MA) Computer Science, Computational Chemistry, Bioinformatics, Statistics or a related quantitative or scientific field (Preferred)
- Ph. D. Computer Science, Computational Chemistry, Bioinformatics, Statistics or a related quantitative or scientific field (Preferred)
Experience:
- 5 years or more in Developing and deploying machine learning or AI systems in a production environment
- 5 years or more in Advanced proficiency with Python, agentic frameworks
- 5 years or more in Hands on experience building and evaluating LLM and agentic applications including retrieval-augmented generation, structured output, tool use, multi-step agent orchestration, and quantitative evaluation
- 5 years or more in NLP experience over technical or scientific text, including document parsing, information extraction and semantic search
- 5 years or more in AI system validation or AI governance in a regulated industry
Specialized Knowledge:
- • Demonstrated ability to work within documented, controlled processes and produce audit-quality technical documentation (required)
- • Databricks (Unity Catalog, Delta Lake, MLflow) and cloud ML platforms such as Amazon Bedrock or SageMaker (preferred)
- • Knowledge / experience with GxP-regulated environment; familiarity with 21 CFR Part 11, computerized system validation, or GAMP 5 (preferred)
- • Knowledge of ANDA, NDA, or DMF submission content, eCTD structure, or health authority correspondence (preferred)
The salary range for this position ranges from $190,000 - $225,000 per year. In addition, Amneal offers a short-term incentive opportunity, such as a bonus or performance-based award with this position within the first 12 months. Amneal ranges reflect the Company’s good faith estimate of what Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, experience, geographic location and other relevant skills.
At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that help you enjoy your career alongside life’s many other commitments and opportunities.
Skills Required
- Bachelor’s degree in Computer Science, Computational Chemistry, Bioinformatics, Statistics, or a related quantitative or scientific field, or equivalent demonstrated experience
- At least 5 years developing and deploying machine learning or AI systems in production environments
- At least 5 years of advanced proficiency with Python and agentic frameworks
- At least 5 years building and evaluating LLM and agentic applications, including retrieval-augmented generation, structured output, tool use, multi-step orchestration, and quantitative evaluation
- At least 5 years of NLP experience with technical or scientific text, including document parsing, information extraction, and semantic search
- At least 5 years of AI system validation or AI governance experience in a regulated industry
- Ability to work within documented, controlled processes and produce audit-quality technical documentation
- Master’s degree in Computer Science, Computational Chemistry, Bioinformatics, Statistics, or a related quantitative or scientific field
- Ph.D. in Computer Science, Computational Chemistry, Bioinformatics, Statistics, or a related quantitative or scientific field
- Experience with Databricks, Unity Catalog, Delta Lake, MLflow, and cloud ML platforms such as Amazon Bedrock or SageMaker
- Knowledge or experience with GxP-regulated environments, 21 CFR Part 11, computerized system validation, or GAMP 5
- Knowledge of ANDA, NDA, or DMF submission content, eCTD structure, or health authority correspondence
Amneal Pharmaceuticals Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Amneal Pharmaceuticals and has not been reviewed or approved by Amneal Pharmaceuticals.
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Healthcare Strength — Medical coverage is presented as comprehensive with day-one eligibility for many U.S. roles, supported by wellness resources and transparency around plan information.
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Affordable Benefits — Employer contributions toward health coverage are described as generous, including periods where cost increases were absorbed and future employee contributions kept below broader trends.
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Retirement Support — A 401(k) plan with a company match and strong participation is positioned as a core element of the Total Rewards package.
Amneal Pharmaceuticals Insights
What We Do
Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) is guided by a simple belief: essential medicines should be accessible to everyone. What began as a promise to deliver high-quality, affordable medicines has evolved into a diversified portfolio spanning complex generics and injectables, biosimilars, and specialty medicines, including more than 290 products, with scale and capabilities that help reach patients across the healthcare system while combining world-class precision with a deep sense of personal responsibility for every dose we deliver. Content is for informational purposes only and 3rd party content does not reflect Amneal’s opinions. Amneal has the right to remove comments that violate another’s copyright or intellectual property, mention an Amneal product, use profanity or are defamatory, promote and solicit for third-party sites, initiatives, or products, or are factually inaccurate or misleading or spam. Amneal recommends that you consult with your healthcare provider regarding personal health matters. To report a product complaint or adverse event related to an Amneal product, contact Drug Safety at 877-835-5472, option 3 or [email protected]. If you are currently experiencing a life-threatening event, please immediately contact 911.
