Principal Scientist, Analytical Chemistry

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Job description

Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases. Eikon's discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which enable real time, molecular-resolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets.

Position

The Principal Scientist, Analytical Chemistry is responsible for overseeing the development, optimization, method transfer, and validation of analytical methods, ensuring compliance with regulatory standards. This position includes laboratory responsibilities, developing in-house analytical methods, designing phase-appropriate analytical control strategies, and leading cross-functional teams to advance Eikon Therapeutics product pipeline. This role requires a strong background in analytical chemistry and regulatory requirements. Experience in setting up drug substance, and drug product specifications is highly preferred.

About You

You are an experienced and driven analytical chemist with a deep understanding of regulatory requirements and a commitment to excellence in drug development. With a strong background in CMC analytical chemistry, you have successfully led projects through various stages, always ensuring rigorous compliance with FDA, EMA, and other regulatory standards. You have a demonstrated track record in developing, validating, and optimizing/transferring analytical methods and possess hands-on knowledge of quality control processes. Known for your leadership abilities, you are skilled in coordinating cross-functional teams and managing external CRO/CDMO partnerships to drive projects forward. Your problem-solving mindset and clear communication style enable you to navigate complex regulatory landscapes and deliver high-quality analytical support. You thrive in a fast-paced, dynamic environment, balancing multiple priorities while maintaining the highest quality standards. This role offers the opportunity to contribute to the advancement of innovative drug products and play a key role in the growth and success of the company. If you are a strategic thinker with a passion for pharmaceutical development, we encourage you to apply.

What You'll Do

• Serve as the project lead in the development, method transfer, and validation of analytical methods from early clinical stage through commercial stages.
• Monitor project progress and ensure milestones are met.
• 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.

Qualifications:

• Postdoc fellowship plus 7 years or a PhD plus a minimum of 10 years of relevant experience or a Master's degree with 12 years of relevant experience in process chemistry and drug substance development.
• CMC analytical knowledge and experience with various dosage forms (solid oral, injectable, etc.) is required.
• 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.
• 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.

At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:

• 401k plan with company matching
• Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%)
• Mental health and wellness benefits
• Weeklong summer and winter holiday shutdowns
• Generous paid time off and holiday policies
• Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies
• Enhanced parental leave benefit
• Daily subsidized lunch program when on-site

The expected salary range for this role is $178,000 to $194,750 depending on skills, competency, and the market demand for your expertise.

Eikon is proud to be an equal opportunity employer and will consider all qualified applicants for employment.

In accordance with the Company's duty to provide and maintain a safe workplace, the Company requires all employees to be Fully Vaccinated with one of the FDA approved COVID-19 vaccines, which includes those vaccines that have received the FDA's emergency use authorization. You will be expected to be Fully Vaccinated as of your Start Date. If you believe that you are exempt from this requirement under an applicable law or regulations, including Americans with Disabilities Act and California's Fair Employment and Housing Act, you will need to contact the Company's Human Resources group. For purposes of this section, Fully Vaccinated means (i) the completion of the vaccination regimen as approved by the FDA (by way of example, 2 doses of the Pfizer or Moderna vaccine and 1 dose of the Johnson and Johnson vaccine), and (ii) timely receiving booster vaccination, as recommended by the Centers for Disease Control and Prevention.

We are currently not accepting any new third-party agencies or firms at this time. Please do not forward unsolicited agency resumes to our website, employees or Human Resources. Eikon Therapeutics will not pay fees to any third-party agency or firm associated with unsolicited resumes.

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