Glaukos

Sr. Scientist II, Biologics

Glaukos • $100K — $130K *
Aliso Viejo, CA 92656In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
2 months ago
Job Overview by Ladders

Qualifications

  • Ph.D. (8+ years) or M.S. (10+ years) in biochemistry, immunoanalytical/analytical chemistry, or related scientific field.
  • 6+ years of pharmaceutical industry experience in large molecule analytical development and regulatory submissions.
  • Strong hands-on knowledge of chromatographic theory and technology.
  • Experience with analytical techniques like HPLC, LC-MS, and various bioassays for large molecules.
  • Excellent written and verbal communication skills, especially in regulated environments.
  • Project management skills to handle multiple projects and resource evaluations.

Responsibilities

  • Develop, validate, and transfer analytical and biological potency assay methods.
  • Oversee stability studies and conduct trending analysis.
  • Coordinate and monitor analytical activities internally and with CROs/CMOs.
  • Provide scientific conclusions based on data from studies to support decision-making.
  • Prepare protocols and technical reports for regulatory submissions.
  • Communicate project direction and progress to teams and management.
  • Lead and provide guidance to team scientists.
  • Contribute biological insights to design novel proteins.

Benefits

  • Opportunity to work on cutting-edge assay technologies and techniques.
  • Collaborative work environment with cross-functional teams.
  • Involvement in all stages of drug development from clinical studies to commercialization.
  • Role as a subject matter expert influencing project teams and discussions.
  • Access to professional development and training in analytics and regulatory affairs.
Full Job Description
Job Description

Sr. Scientist II, Biologics, Aliso Viejo, CA

What You'll Do:

This position is within the Analytical Technologies team of the Applied Research department. This role focuses on developing, validating, and transferring analytical and biological potency assay and cell-based assay methods to support large molecule drug development and formulations from early-stage clinical studies through commercialization. The position also involves overseeing stability studies and conducting trending analysis. 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 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.
  • 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 independently 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 to support decision making.
  • Maintains expertise in cutting-edge assay technologies and continuously develops excellent assay troubleshooting skills in analytical methodologies used for the characterization of drug delivery systems and protein formulations for drug release, potency, biological activity, stability, impurity testing and aggregation profile.
  • Collaborate with protein/peptide engineering SMEs and contribute biological knowledge to the design of novel proteins with desired pharmacological characteristics.
  • Prepares high quality experimental protocols and technical reports in support of regulatory submissions.
  • Independently authors appropriate portions of CMC section of INDs, NDAs and prepares responses to regulatory questions.
  • Provides training and guidance to scientists in the team.
  • Provides regular and open communication to keep project teams, and management informed of direction, progress and strategic developments in supporting and meeting companies' goals and objectives.
  • Actively participates in departmental committees/meetings as an advisor in scientific, administrative and regulatory areas.
  • 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 and bioanalytical 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, IEX-HPLC, SEC-HPLC, LC-MS, CE techniques, cIEF, MSD, ELISA, ddPCR, qPCR, Octet, Biacore, and other common analytical and bioassay techniques used to determine potency, purity, and in-vitro performance of drug substance and drug product for large molecules.
  • Ability to independently lead 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., GxP, 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.
  • Strong scientific and leadership skills with the ability to be a subject matter expert at matrix teams and influence and collaborate.
  • 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 8+ years) or M.S. (10+ years) in biochemistry, immunoanalytical/analytical chemistry, or related scientific field and 6+ years of pharmaceutical industry experience in large molecule analytical development, drug product analysis and regulatory submissions.

#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

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