New

Principal Scientist, CMC Analytical

Millbrae, CA

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, CMC Analytical is responsible for overseeing the development, optimization, method transfer, and validation of analytical methods, ensuring compliance with regulatory standards. This position involves independently managing both drug substance and drug product analytical activities, overseeing laboratory operations—both hands-on and in collaboration with CMOs, developing in-house analytical methods, and designing phase-appropriate analytical control strategies. The role also includes leading cross-functional teams to advance the company’s product pipeline. A strong background in analytical chemistry and regulatory requirements is essential. Experience in establishing specifications for drug substances and drug products is highly preferred.'

About You

You are a strategic thinker with a passion for pharmaceutical development You are excited that 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.

What You'll Do

  • 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. Additionally, 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 Ph.D. plus minimum 10 years of relevant experience; or Master's plus 18 years of relevant experience.
  • 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.
  • Experience with ICH requirements required. 
  • 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 $179,000 to $195,700 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.

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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