Director, CMC Process Chemistry
Job Posting for Director, CMC Process Chemistry at Eikon Therapeutics
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 $196,000 to $225,000 depending on skills, competency, and the market demand for your expertise.
Salary.com Estimation for Director, CMC Process Chemistry in Hayward, CA
$245,401 to $326,862
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