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.
As a Director in CMC Analytical Chemistry, you will lead all CMC analytical development activities to support Drug Substance and Drug Product manufacturing for our novel biotechnological products. You will work closely with cross-functional teams, including DS/DP, Discovery Analytical, Regulatory, and Quality Assurance, to ensure seamless integration of analytical chemistry with our overall research and production workflows. The successful candidate will have a strong background in analytical chemistry, method development and validation, possess exceptional problem-solving skills and leadership skills.
You’re passionate about drug discovery and developing effective treatments for patients. You are experienced and enthusiastic about career/people development and mentoring other scientists. You’re conscientious, and organized, and have an ability to see the “big picture”. You thrive in a fast-paced environment and enjoy pushing the edge of what is possible.
What You’ll Do
- You will be responsible for the development, optimization, validation, and transfer of analytical test methods for drug substance, drug product, and raw materials through all phases of product development.
- Strategic Leadership: Formulate and implement the strategic vision for the analytical chemistry CMC group, aligning with the broader company strategy.
- Method Development and Validation: Oversee the development, validation, and optimization of analytical methods for drug substances and products.
- Technology Transfer: Ensure the seamless transfer of analytical methods from R&D to CDMOs or between CDMOs.
- Cross-Functional Collaboration: Partner with other departments such as Process Chemistry, Formulation, and Quality to synchronize efforts and attain project milestones.
- Resource Management: Handle resource allocation and project prioritization to align with organizational objectives
- Team Development: Mentor, train, and develop team members to cultivate a culture of innovation, excellence, and continuous growth.
- Stakeholder Engagement: Communicate with senior management, external collaborators, and regulatory agencies to convey progress and address any arising issues.
- Regulatory Compliance: Lead the team in preparing relevant CMC sections for regulatory submissions, ensuring that all documentation and processes adhere to global regulatory standards.
- Cross-Functional Collaboration: Collaborate closely with other departments such as Discovery Analytical, Process Chemistry, Formulation, and Quality 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.
- Employ state-of-the-art tools, techniques, and statistical methodologies to analyze and interpret data, contributing to process understanding and improvement.
- Ph.D. in Analytical Chemistry, or related field with minimum of 10+ years of industry experience in analytical chemistry with a proven track record in leading teams.
- Strong understanding of GMP practices and regulatory guidelines pertaining to analytical method development and validation.
- Demonstrated experience in technology transfer, and managing collaborations with CMOs.
- Proficient in the use of modern analytical tools and techniques.
- Excellent leadership, communication, and interpersonal skills with demonstrated ability to think strategically and execute methodically.
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 $196,000 to $225,000 depending on skills, competency, and the market demand for your expertise.