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Director, CMC Process Chemistry

Employer
Eikon Therapeutics
Location
Hayward, CA / Jersey City, NJ / New York, NY / Remote
Start date
Jan 24, 2024

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Discipline
Engineering, Science/R&D, Chemistry, CMC
Required Education
Bachelors Degree
Position Type
Full time

Job Details

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

We are seeking a visionary and accomplished Director of CMC Process Chemistry. You will play a crucial role in developing and optimizing chemical processes for the synthesis and production of our novel small molecule products. You will work closely with cross-functional teams, including R&D, regulatory affairs, and Quality Assurance, to ensure seamless integration of process chemistry with our overall research and production workflows. The successful candidate will have a strong background in organic chemistry, process development, and possess exceptional problem-solving skills. 

About You 

This is an exciting opportunity for a talented and passionate Drug Substance professional to make a significant impact on the development of groundbreaking pharmaceutical products. The ideal candidate for this role should possess demonstrated leadership experience, with the ability to manage and inspire multidisciplinary teams, driving transformative impact across cross-functional projects. Exceptional problem-solving skills, meticulous attention to detail, and dynamic adaptability to evolving research paradigms are required, along with outstanding communication and interpersonal skills to foster clear interactions with colleagues and cultivate an environment of collaborative achievement. 

What You’ll Do 

  • Provide strategic direction and scientific leadership for the process chemistry CMC group, ensuring alignment with the overall company strategy. 
  • Oversee the drug substance manufacturing activities, including process development, management of internal process development activities and clinical contract manufacturing at CDMOs.  
  • Process Development: Oversee the development, optimization, and scale-up of robust and cost-effective synthetic routes for drug substances.
  • Technology Transfer: Ensure smooth transfer of processes from R&D to manufacturing sites or between manufacturing sites.
  • Regulatory Compliance: Lead the team in preparing relevant CMC sections for regulatory submissions, ensuring all documentation and procedures are in compliance with global regulatory standards.
  • Cross-Functional Collaboration: Collaborate closely with other departments such as Analytical, Formulation, Medicinal Chemistry, Quality and project teams to ensure seamless flow of information and alignment on project goals.
  • Resource Allocation: Manage resource allocation and prioritize projects in line with company objectives, ensuring timely and efficient progress.
  • Team Management: Mentor, coach, and develop staff, ensuring continuous professional growth and fostering a culture of innovation and excellence.
  • Stakeholder Management: Liaise with senior management, external partners, and regulatory agencies to communicate progress and address any concerns or challenges.
  • Budget Management: Oversee the department budget, ensuring efficient use of resources and staying within fiscal constraints.
  • Continuous Improvement: Identify and implement new technologies, methodologies, and practices to enhance the efficiency and capabilities of the team.
  • Employ state-of-the-art tools, techniques, and statistical methodologies to analyze and interpret data, contributing to process understanding and improvement.

Qualifications

  • Post Graduate degree with 10+ years of relevant experience or a Bachelor's degree with 12+ years in Organic Chemistry, Chemical Engineering, or related field.
  • Proven experience in process development, reaction optimization, and scale-up of chemical processes in a biotech, pharmaceutical, or related industry. 
  • Demonstrated leadership experience in drug substance process characterization, process validation, including IQ, OQ, PQ protocols, and validation master plans.  
  • Excellent problem-solving skills with the ability to approach challenges creatively and pragmatically. 
  • Demonstrated written and verbal communication skills with ability to interact effectively within cross-functional teams. Experience in informing senior management, executives, and/or major customers on matters of significance to the organization. 
  • Track record of successfully managing multiple projects simultaneously and meeting project deadlines. 
  • Experience in mentoring and developing junior staff.  

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 $200,000 to $218,500 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.

Company

Eikon is a pioneering drug discovery and development company that leverages superior engineering and high-performance computing to analyze single molecule protein behavior in living cells. We are engineering a battery of innovative tools and technologies for biological exploration in drug discovery and beyond.

Eikon thrives on the energy and creativity of interdisciplinary teams. We are physicists and chemists, biologists and engineers. We spend our days context-switching between multiple scientific languages. We work with lasers, super-resolution microscopes, and robot arms. We leverage machine learning, cell line engineering, and the collective intelligence of world-class scientists and technologists to observe therapeutically relevant biology in a way no one has before.

We’re endlessly curious, intellectually honest and we love what we do. We’re driven to learn the true mechanisms of biology and pharmacology at the molecular level, to make the biggest difference in as many lives as possible.

Company info
Website
Location
3929 Point Eden Way
Hayward
CA
94545
United States

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