Drug Substance Development Manager

3 weeks ago


Hayward, California, United States Eikon Therapeutics Full time

About the Role

As a seasoned professional in drug substance development, you will lead internal research and external manufacturing efforts for small molecule drug substances at Contract Manufacturing Organizations (CMOs). Your expertise will ensure compliance with regulatory standards, such as those set by the FDA and EMA. You will work collaboratively with cross-functional teams to advance our product pipeline.

Key Responsibilities

- Serve as project lead for process development and manufacturing of drug substances and regulatory starting materials for clinical programs in all phases of development.
- Oversee scale-up activities at CMOs and develop robust and scalable manufacturing processes.
- Collaborate with Research Project Teams, Regulatory Affairs, Quality Assurance, Manufacturing, Supply Chain, and Clinical Operations to ensure seamless product development and scale-up.
- Develop and execute project plans, timelines, and develop project strategy.
- Ensure all CMC activities comply with regulatory requirements.

Qualifications

- A postdoc fellowship plus 7 years or a PhD plus a minimum of 10 years of relevant experience or a Master's degree with 12 years of relevant experience in process chemistry and drug substance development.
- Experience with cGMP manufacturing of drug substances is required. Proven track record of successful First-in-Human (FIH) development, process optimization, and regulatory submissions is essential. Strong understanding of FDA and EMA regulatory requirements and quality systems is also necessary.

What We Offer

We offer an estimated salary range of $178,000 to $194,750 depending on skills, competency, and market demand for your expertise. Our compensation package includes bonus and equity compensation, as well as several generous benefit programs, including a 401k plan with company matching, medical, dental, and vision insurance, mental health and wellness benefits, weeklong summer and winter holiday shutdowns, and enhanced parental leave benefits. The expected salary is based on the company overview, job description, and location.



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