Glaukos

Sr. Scientist - Small Molecule

Glaukos • $97K — $122K *
Aliso Viejo, CA 92656In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
1 month ago
Job Overview by Ladders

Qualifications

  • Ph.D. (3+ years) or M.S. (8+ years) in analytical chemistry or related field.
  • 3+ years experience in pharmaceutical analytical development for small and large molecules.
  • Strong knowledge of chromatographic technologies (HPLC, UPLC, GC, LC-MS).
  • Experience in regulatory environments (GMP, ICH, FDA).
  • Project management skills and ability to handle multiple projects.

Responsibilities

  • Design and implement analytical methods for drug development stages.
  • Troubleshoot technical challenges and ensure high-quality data generation.
  • Evaluate and interpret data from stability studies with scientific conclusions.
  • Prepare protocols and reports for regulatory submissions and address regulatory queries.
  • Lead analytical contributions in CMC project teams and QC collaboration.
  • Stay updated on analytical methods and explore innovative techniques.

Benefits

  • Rich bonus and benefits package.
Full Job Description
Job Description

How You'll Contribute:

This position is within the Analytical Development team of the Applied Research department. This role focuses on developing, validating, and transferring analytical methods to support small and large molecule drug development and formulations from early-stage clinical studies up to commercialization.

The position will establish, coordinate and monitor analytical related activities both internally and with CROs and CMOs to ensure quality and timeliness of projects. The position also involves overseeing stability studies and conducting trending analysis for drug substance and drug product. The ideal candidate works effectively and collaboratively with cross-functional groups and will represent as analytical lead on CMC project teams. This position is expected to communicate data both verbally at group meetings and through written documents and reports and be able to comfortably multitask across projects and disciplines.

What You'll Do:
  • Provides technical expertise to design, conduct, and implement analytical and development activities for large and small molecules to support all stages of drug development.
  • Troubleshoots and solves technical challenges in a timely manner and ensures generation of high-quality scientific data.
  • Evaluates and interprets data from release and stability studies and provides scientific conclusions.
  • Maintains expertise in cutting-edge assay technologies used for the characterization of drug delivery systems for drug release, potency, stability, impurity testing and aggregation profile.
  • Prepares high quality experimental protocols and technical reports in support of regulatory submissions. Supports authoring appropriate portions of CMC section of INDs, NDAs and prepares responses to regulatory questions.
  • Represents as analytical lead on CMC project teams, provides scientific solutions and contributes to team discussions. Support QC department with establishing robust methods, product specifications, method validations and method transfers.
  • Proactively develops and maintains knowledge in current analytical sciences and investigates new technologies, recommends and implements innovative techniques to the team.

How You'll Get There:
  • Strong hands-on knowledge of chromatographic theory and technology.
  • Working knowledge of HPLC, UPLC, GC, LC-MS, UV/Vis, Dissolution and other common analytical techniques used to determine potency, purity, and in-vitro performance of drug substance and drug product.
  • Ability to perform investigations and troubleshoot technical problems at all stages of development, being detail oriented are important attributes.
  • Excellent written and verbal communication skills; prior experience working within regulated environments (e.g., GMP, ICH, FDA) to ensure analytical activities meet compliance standards and support regulatory filings and inspections.
  • Strong ability and knowledge to develop, validate and transfer methods. Experience in oversight of stability studies, conducting trend analysis and interpreting data.
  • Ability to work within a diverse workforce, scientific participation and collaboration with colleagues in industry, academia and regulatory agencies.
  • Experience in interacting with pharmaceutical CROs and CMOs and providing guidance.
  • Project management skills including the ability to manage multiple projects and evaluate project resource requirements. Strong knowledge of Quality systems, Drug Product Manufacturing and Validation.
  • Good knowledge of drug development and product regulations.
  • Ph.D. (with 3+ years) or M.S. (8+ years) in analytical chemistry, pharmaceutical chemistry, pharmaceutical sciences, or related scientific field and 3+ years of pharmaceutical industry experience in small or large molecule analytical development, and
  • Salary Range: 97900. - 122400. plus rich package of bonus, benefits and more!

#GKOSUS

About Glaukos

Glaukos Corporation is an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases. The company pioneered Micro-Invasive Glaucoma Surgery, or MIGS, to revolutionize the traditional glaucoma treatment and management paradigm. Glaukos launched the iStent, its first MIGS device, in the United States in 2012 and is leveraging its platform technology to build a comprehensive and proprietary portfolio of micro-scale injectable therapies designed to address the complete range of glaucoma disease states and progression. The company's second-generation MIGS device, the iStent inject, was approved by the FDA in June 2018. Glaukos is also developing a pipeline of innovative technologies in corneal health, including the recently acquired Microline surgical platform, as well as novel drug delivery technologies.
Learn more about Glaukos
Size
727 employees
Market Cap
$1.9 billion
Industry
Healthcare
Net Income
-$120.3 million
Founded
1998
5 Year Trend
+20.8%
Revenue
$224.9 million
NASDAQ
GKOS
* Ladders Estimates

Similar Jobs

Ad banner background

Get Ready For Your
Next Interview

More Jobs at Glaukos

More Pharmaceuticals & Biotech Jobs

  • Director, Customer Success
    $150K — $250K *
    NAYA Therapeutics
    Chicago Heights, IL 60411 (Cook County)
    Yesterday
  • Director, Customer Success
    $150K — $250K *
    NAYA Therapeutics, Inc.
    Deming, NM 88030 (Luna County)
    Yesterday
  • CSV Engineer
    $100K — $130K *
    Katalyst HealthCares and Life Sciences
    Seattle, WA 98115 (King County)
    Today
  • Lab Technician
    $70K — $115K *
    Blueland
    Boca Raton, FL 33433 (Palm Beach County)
    Today
  • Thermo Fisher Scientific
    Staff QA Engineer
    $90K — $120K *
    Thermo Fisher Scientific
    Greenville, NC 27858 (Pitt County)
    Today

Find similar Sr. Scientist - Small Molecule jobs:

NationwideAliso Viejo, CA