Principal Scientist, CMC Analytical at Eikon Therapeutics

Millbrae, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biopharmaceutical, BiotechnologyIndustries

Requirements

Postdoc fellowship plus 7 years; or Ph.D. plus minimum 10 years; or Master's plus 18 years of relevant experience
CMC analytical knowledge and experience with various dosage forms (solid oral, injectable, etc.)
Proven track record of successfully providing analytical support for FIH formulation development and regulatory submissions
Strong understanding of FDA and EMA regulatory requirements and quality systems
Experience with ICH requirements
Excellent communication, leadership, and problem-solving skills with hands-on knowledge of analytical methods and quality control processes
Ability to work in a fast-paced, dynamic environment and manage multiple priorities
Strong analytical and problem-solving skills
Excellent interpersonal and communication skills, capable of leading and motivating teams
Commitment to maintaining high quality standards
Strong background in analytical chemistry and regulatory requirements
Experience in establishing specifications for drug substances and drug products (highly preferred)

Responsibilities

Serve as the project lead for both drug substance and drug product, overseeing the development, method transfer, and validation of analytical methods from early clinical stages through to commercialization. Monitor project progress and ensure that key milestones are achieved
Oversee analytical projects and manage timelines at CROs/CDMOs
Collaborate with cross-functional teams including Research Project Teams, Regulatory Affairs, Quality Assurance, Manufacturing, Supply Chain and Clinical Operations, as well as CMC-drug substance and drug product formulation teams, to ensure seamless product development to commercial
Develop and execute analytical project plans, timelines, and project strategy
Ensure all CMC activities comply with regulatory requirements (FDA, EMA, etc.)
Prepare and review CMC sections of regulatory submissions, including INDs, NDAs, and BLAs
Interact with regulatory agencies to address CMC-related queries and provide necessary documentation
Implement online process analytical techniques to enhance control strategies
Provide analytical technical expertise, including laboratory responsibilities, to support drug product formulation, drug substance synthesis, and manufacturing
Stay updated on industry trends, technological advancements, and the latest developments in analytical chemistry and regulatory trends
Mentor and develop junior staff members
Oversee the development, optimization, method transfer, and validation of analytical methods, ensuring compliance with regulatory standards
Independently manage both drug substance and drug product analytical activities
Oversee laboratory operations—both hands-on and in collaboration with CMOs
Develop in-house analytical methods
Design phase-appropriate analytical control strategies
Lead cross-functional teams to advance the company’s product pipeline

Skills

Analytical Chemistry

CMC Analytical

Method Development

Method Optimization

Method Transfer

Method Validation

Regulatory Compliance

Drug Substance Analysis

Drug Product Analysis

Laboratory Operations

Cross-Functional Leadership

Phase-Appropriate Controls

Eikon Therapeutics

Biotech startup developing innovative medicines

About Eikon Therapeutics

Eikon Therapeutics focuses on discovering and developing new medicines in the pharmaceutical industry. The company employs advanced technologies to study biological systems, aiming to identify new drug targets by examining the dynamic aspects of biology rather than just static chemical processes. Their team consists of diverse professionals, including data scientists, chemists, and engineers, which allows them to combine science and engineering to create new therapies that aim to improve and extend life. A key feature of Eikon's approach is their proprietary single-molecule tracking (SMT) platform, which enables rapid visualization of protein movements in living cells. This technology, along with artificial intelligence and automation, allows for precise inventorying of molecular interactions. Eikon Therapeutics targets patients with serious diseases who need effective treatments, generating revenue through the development and commercialization of their therapies.

Hayward, CaliforniaHeadquarters

2019Year Founded

$750.8MTotal Funding

SERIES_CCompany Stage

AI & Machine Learning, BiotechnologyIndustries

201-500Employees

Benefits

401(k) Company Match

Medical (premiums covered by Eikon at 95%)

Dental Insurance

Vision Insurance

Mental Health Support

Unlimited Paid Time Off

Paid Holidays

Life Insurance

Enhanced Parental Leave

Daily subsidized lunch program

Risks

Competition from biotech unicorns like Abogen Biosciences is increasing.

Integrating new clinical-stage assets may delay drug development timelines.

Reliance on SMT technology risks obsolescence from emerging molecular biology technologies.

Differentiation

Eikon uses proprietary single-molecule tracking for real-time protein movement analysis.

The company integrates AI and automation for large-scale molecular interaction studies.

Eikon's diverse team combines expertise in science, engineering, and technology.

Upsides

Growing interest in SMT technology boosts Eikon's drug discovery potential.

Partnerships with AI firms enhance Eikon's drug candidate identification.

Rising demand for precision medicine aligns with Eikon's focus on dynamic biology.

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