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Hplc Scientist Jobs in Indiana (NOW HIRING)

Elanco

Sr Research Scientist

Indianapolis, IN · Hybrid

$94K - $120K/yr

Experience: Strong expertise in chromatographic (HPLC/UPLC), spectroscopic (UV/VIS), and ... Proven scientific leadership skills combined with strong problem-solving and creative thinking ...

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Hplc Scientist information

What is an HPLC scientist?

HPLC Scientists are laboratory professionals who specialize in using High-Performance Liquid Chromatography (HPLC) to analyze and separate compounds in various samples. They develop, validate, and perform analytical methods to test pharmaceuticals, environmental samples, food, or other substances. Their work ensures the accuracy and reliability of chemical analysis, often supporting research, quality control, or regulatory compliance. HPLC Scientists typically have backgrounds in chemistry, biochemistry, or related fields and are skilled in instrumentation, data analysis, and laboratory best practices.

What skills and qualifications are needed to be an HPLC scientist?

To thrive as an HPLC Scientist, a strong background in analytical chemistry, laboratory techniques, and a relevant science degree is essential. Expertise in operating and troubleshooting HPLC instrumentation, familiarity with chromatography software (such as Empower or ChemStation), and understanding of regulatory standards (like GLP or GMP) are typically required. Strong attention to detail, problem-solving abilities, and effective communication skills help distinguish top performers in this role. These skills are crucial for generating accurate data, maintaining compliance, and ensuring reliable results in pharmaceutical, environmental, or food testing laboratories.

What challenges do HPLC scientists face and how are they addressed?

HPLC Scientists often encounter challenges such as method development difficulties, sample matrix interferences, and instrument maintenance issues. To address these, scientists work closely with team members to optimize protocols, troubleshoot equipment, and validate methods for accuracy and reliability. Regular collaboration with quality assurance and analytical teams ensures compliance with regulatory standards and efficient workflow. Lab environments typically provide access to technical support and ongoing training to help HPLC Scientists stay updated with the latest advancements and best practices.

What is the difference between Hplc Scientist vs Analytical Chemist?

AspectHplc ScientistAnalytical Chemist
CredentialsBachelor's or Master's in Chemistry, Biochemistry, or related field; experience with HPLC techniquesBachelor's or Master's in Chemistry, Analytical Chemistry, or related field; proficiency in analytical methods
Work EnvironmentLaboratories focusing on chromatography and method developmentVaried labs including quality control, research, and development
Industry UsagePharmaceutical, biotech, and chemical industriesPharmaceutical, environmental, food, and chemical industries

Hplc Scientists specialize in developing and optimizing HPLC methods, often working in pharmaceutical and biotech labs. Analytical Chemists have broader roles in analyzing samples across various industries. While both roles require chemistry expertise and laboratory skills, Hplc Scientists focus more on chromatography techniques, whereas Analytical Chemists may handle diverse analytical methods.

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The top searched job categories for Hplc Scientist jobs in Indiana are:

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Cities in Indiana with the most Hplc Scientist job openings:

Hplc Scientist jobs near you

Senior Scientist, Quality CMC

Aquestive Therapeutics

Portage, IN • On-site

Full-time

Re-posted 8 days ago

Job description

Job Summary:
The Senior Scientist, CMC Quality, bridges analytical science and product performance, providing scientific leadership to distinguish analytical artifacts from true product, process, or manufacturing risks. This role drives complex investigations, informs quality-critical decisions, and partners cross-functionally to ensure sound, risk-based outcomes throughout the product lifecycle.
Responsibilities:
  • Serve as QC's primary interface to AR&D and Engineering, connecting analytical findings to process variability, formulation behavior, manufacturing deviations.
  • Support PQR/APQR product quality narratives, stability trend interpretation.
  • Lead and provide scientific oversight for complex OOS, OOT, deviation, and product quality investigations, determining whether observations arise from analytical, sampling, product, or manufacturing-related factors.
  • Lead the development and review of technically complex investigations, risk assessments, scientific rationales, and regulatory support documentation.
  • Provide independent, evidence-based scientific recommendations to support Quality decision-making and governance.
  • Understand method capability vs. product behavior.
  • Identify when method limitations drive variability, specifications may not reflect true capability, escalating systemic or recurring issues (i.e., lifecycle management).
  • Lead or support analytical and CMC quality improvement projects, as assigned.
  • Provide scientific assessment of stability trends, out of trend (OOT results), and potential impact to product quality.
  • Partner with Quality, AR&D and Regulatory to support IND/NDA/MAA submissions, post-approval commitments and annual updates.
  • Develop hypothesis-driven investigation strategies grounded in product behavior or formulation/process knowledge.
  • Drive root cause analysis and scientifically sound CAPAs.
  • Mentor junior scientists and provide technical guidance during investigations and problem-solving activities.

Qualifications:
  • BS in Chemistry, Pharmaceutical Sciences, or related field required.
  • Minimum of 8 years in pharmaceutical/biotech Quality Control, Chemistry, Manufacturing Controls (CMC), or Analytical Sciences
  • Demonstrated ownership of complex OOS, OOT, and deviation investigations, including: developing investigation strategies, performing root cause analysis, defending conclusions and CAPAs
  • Significant experience in: Cross-functional investigations involving QC, Manufacturing, QA, and AR&D
  • Significant experience in interpreting analytical data in the context of product quality and process performance
  • Significant experience in stability programs, trend analysis, and product performance evaluation
  • Significant experience in analytical method capability, variability, and limitations
  • Strong understanding of: CMC development and commercialization, GMP and global regulatory expectations (FDA, EMA, ICH), OOS/OOT investigation frameworks and industry best practices
  • Demonstrated ability to: influence cross-functional teams without authority, articulate and defend scientific positions in QA and leadership forums
  • Strong business and product acumen, with understanding of: impact of quality decisions on supply, regulatory risk, and product lifecycle
  • Experience supporting regulatory submissions (IND/NDA/MAA), inspections, or audits preferred
  • Experience with instrumental techniques such as GC, HPLC, Dissolution.
  • Some travel required

The above statements are intended to describe the general nature and level of the work being performed by colleagues assigned to this position. This is not intended to be an exhaustive list of all responsibilities, duties, and skills required. Aquestive reserves the right to make changes to the job description whenever necessary.
As part of Aquestive's employment process, final candidate will be required to complete a drug test and background check prior to employment commencing. Please Note: Aquestive is a drug-free workplace and has a drug free workplace policy in place.
Aquestive provides equal employment opportunities to all colleagues 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.
The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.
Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.

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