Associate Director, CMC Drug Product

Position

The Associate Director, CMC Drug Product will lead drug product development and clinical manufacturing activities across multiple programs, with a strong focus on early- to mid-stage small-molecule oral solid dose compounds. This individual will be responsible for defining and executing drug product strategies from preclinical development through clinical supply, while ensuring compliance with global regulatory requirements. In this role, you will serve as the primary drug product CMC lead, partnering closely with internal cross-functional teams and external CDMOs to advance the company's pipeline. The ideal candidate brings deep technical expertise in formulation and process development, strong project leadership skills, and hands-on experience supporting regulatory submissions for early clinical programs.

About You

You are a drug product CMC leader with a strong foundation in pharmaceutical sciences and a proven track record advancing small-molecule oral solid dose programs in a fast-paced biotech environment. You are comfortable owning drug product strategy end-to-end, from preformulation and formulation development through clinical manufacturing and packaging, with particular strength in early-stage development. You thrive in cross-functional settings and are experienced working with CDMOs to deliver phase-appropriate formulations, leveraging solid dose processing technologies such as spray drying and compression. You bring a clear understanding of regulatory expectations for early and mid-stage programs and can translate technical development work into high-quality CMC documentation. You are hands-on when needed, detail-oriented, and proactive in identifying risks, driving solutions, and keeping programs on track.

What You'll Do

• Lead the preclinical formulation development and drug product development from early clinical through commercial stages
• Oversee formulation development and scale-up activities at CDMOs
• Ensure robust and scalable manufacturing processes are in place
• Collaborate with cross-functional teams including Research Project Teams, Regulatory Affairs, Quality Assurance, Manufacturing, Supply Chain and Clinical Operations to ensure seamless product development delivery
• Develop and execute project plans, timelines, and budgets
• Ensure all CMC activities comply with regulatory requirements (FDA, EMA, etc.)
• Prepare and review CMC sections of regulatory submissions, including INDs, NDAs, CTDs, etc.
• Interact with regulatory agencies to address CMC-related queries and provide necessary documentation
• Mentor and develop junior staff members
• Identify and manage external partners, including CMOs and CROs
• Ensure quality and timely delivery of contracted services
• Negotiate contracts and manage vendor performance
• Potential to contribute to setting up new, in-house non-GMP formulation laboratory

Qualifications

• A Master's degree in Pharmaceutics, Chemical Engineering, or a related field with 8+ years of experience in pharmaceutical formulation and drug product development, or a PhD with 6+ years of experience in pharmaceutical formulation and drug product development
• Experience with development of various dosage forms (solid oral, injectable, etc.) and different manufacturing processes (compression, SDD, etc.)
• Previous experience serving as a drug product lead though IND and/or NDA stages
• Proven track record of successful FIH formulation development and regulatory submissions
• Strong understanding of FDA and EMA regulatory requirements and quality systems
• Excellent communication, leadership, and problem-solving skills with hands-on knowledge of cGMPs and quality control processes
• Ability to work in a fast-paced, dynamic environment and manage multiple priorities
• Excellent interpersonal and communication skills, capable of leading and motivating teams

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 $174,000 to $190,000 depending on skills, competency, and the market demand for your expertise.