Senior Director, Cmc Jobs

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 Sr. Director, CMC is central to our Drug Development pipeline.  Reporting to the Vice President, Chemistry, you will establish and build Eikon’s Small Molecule CMC and Process Chemistry functions. 
About You
You’re a process chemistry expert and leader who loves to solve difficult problems and are not discouraged by challenges. You’re a hands-on project manager who thrives in a fast-paced, dynamic environment. You’re well-organized, detail oriented, and take pride in your ability to rapidly analyze situations and judicious decisions. You’re collaborative by nature with uncompromising integrity. You’re conscientious and pay almost obsessive attention to detail, documentation and organization are second nature. You are excited about being a foundational member of a rapidly growing team.
What You'll Do

• Build and develop strategic relationships both internal and external
• Participate in proactive resource and budget planning; including strategic planning, risk-assessment, tracking timelines
• Accountable for designing new routes and robust synthetic processes to successfully deliver preclinical and clinical phase appropriate API batches
• Work collaboratively with cross-functional teams to support drug discovery, IND-enabling studies, CMC IND and NDA filings
• Employ process chemistry techniques to facilitate medicinal chemistry research by overcoming synthetic bottlenecks
• Identification, selection and management of CDMOs for process development, process optimization, GxP manufacturing and analytical activities for drug-substance and drug-product
• Work closely with regulatory affairs to author CMC sections in the IND/IMPD and NDA/MAA filings
• Serve as the technical CMC expert in regulatory interactions
• Lead authorship of SOPs, Protocols/Reports, BPRs and Specification for drug substance and drug product manufacturing activities including facilitating technology transfer to CDMOs
• Represent Process Chemistry and CMC as the technical expert on project teams, providing scientific, and strategic leadership
• Establish and manage all CMC internal and external activities related to process development, manufacturing and validation for our programs
• Lead all CMC development and manufacturing activities with overall responsibility for all drug substance and drug product and analytical development and manufacturing activities from pre-IND through clinical development

Qualifications

• Ability to mentor junior level CMC scientists and supporting team members
• Strong track record of drug discovery experience, success, and leadership, exemplified by advancement of programs through multiple stages of development
• Analytical CMC experience, including method development and validation, is preferred but not required
• Demonstrated ability to prioritize of a portfolio of multiple projects and strategically plan
• Direct experience working with FDA, including knowledge of current ICH guidelines
• Strong written and interpersonal communication and collaboration skills
• Experience successfully completing transition from late-stage development to commercial manufacturing is preferred but not required
• Ability to multi-task in a fast-paced dynamic environment
• In depth understanding of modern process development, solid state characterization, hands on cGMP manufacturing and CDMO management
• Ph.D. in Chemistry or related discipline with at least 15+ years of industrial experience in Process Chemistry and Drug Development

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%)
• Daily subsidized lunch program when on-site
• Generous paid time off and holiday policies
• Mental health and wellness benefits
• Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies
• Weeklong summer and winter holiday shutdowns
• Enhanced parental leave benefit

The expected salary range for this role is $230,000 to $265,000 depending on skills, competency, and the market demand for your expertise.