Eikon Therapeutics
Principal Scientist, Drug Substance
Eikon Therapeutics, Hayward, California, us, 94557
Position
The Principal Scientist, Drug Substance is responsible for supporting internal CMC drug substance research and development, manufacturing of small molecule drug substances at external CMO partners, ensuring compliance with regulatory standards, and collaborating on cross-functional teams to advance the company's product pipeline. This role requires expertise and a strong background in small molecule drug substance development, process chemistry, project leadership, and regulatory requirements.
About You
You are an experienced scientist with expertise in small molecule drug substance development and process chemistry. You have a track record of collaborating on cross-functional development teams to deliver drug substance, while navigating complex regulatory requirements and ensuring high-quality standards for drug substance manufacturing. You are a skilled process chemist with extensive laboratory and hands-on manufacturing expertise, and also adept at working with external CMO partners, guiding production, and troubleshooting as needed. You thrive in a fast-paced, startup environment and are excited about the opportunity to be a foundational member of our growing CMC team. Your proactive nature and collaborative mindset enable you to work seamlessly across cross-functional teams, contributing to the advancement of our pipeline. This role offers the opportunity to contribute to the advancement of innovative drug products and play a key role in the growth and success of the company. If you are a strategic thinker with a passion for pharmaceutical development, we encourage you to apply.
What You’ll Do
Serve as project lead for in-house process development and manufacturing of drug substances and regulatory starting materials for clinical programs in all phases of development.
Oversee process 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 and scale-up.
Develop and execute project plans, timelines, and develop project strategy.
Ensure all CMC activities comply with regulatory requirements (FDA, EMA, etc.).
Prepare and review CMC sections of regulatory submissions, including INDs, NDAs, and BLAs.
Interact with regulatory agencies to address CMC-related queries and provide necessary documentation.
Identify and manage external partners, including CMOs and CROs, including negotiating contracts and managing vendor performance.
Ensure quality and timely delivery of contracted services.
May mentor and develop junior staff members.
Qualifications
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.
Proven track record of successful FIH development, process optimization 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 analytical methods and quality control processes.
Ability to work in a fast-paced, dynamic environment and manage multiple priorities.
Strong analytical and problem-solving skills.
Commitment to maintaining high quality standards.
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 $178,000 to $194,750 depending on skills, competency, and the market demand for your expertise.
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The Principal Scientist, Drug Substance is responsible for supporting internal CMC drug substance research and development, manufacturing of small molecule drug substances at external CMO partners, ensuring compliance with regulatory standards, and collaborating on cross-functional teams to advance the company's product pipeline. This role requires expertise and a strong background in small molecule drug substance development, process chemistry, project leadership, and regulatory requirements.
About You
You are an experienced scientist with expertise in small molecule drug substance development and process chemistry. You have a track record of collaborating on cross-functional development teams to deliver drug substance, while navigating complex regulatory requirements and ensuring high-quality standards for drug substance manufacturing. You are a skilled process chemist with extensive laboratory and hands-on manufacturing expertise, and also adept at working with external CMO partners, guiding production, and troubleshooting as needed. You thrive in a fast-paced, startup environment and are excited about the opportunity to be a foundational member of our growing CMC team. Your proactive nature and collaborative mindset enable you to work seamlessly across cross-functional teams, contributing to the advancement of our pipeline. This role offers the opportunity to contribute to the advancement of innovative drug products and play a key role in the growth and success of the company. If you are a strategic thinker with a passion for pharmaceutical development, we encourage you to apply.
What You’ll Do
Serve as project lead for in-house process development and manufacturing of drug substances and regulatory starting materials for clinical programs in all phases of development.
Oversee process 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 and scale-up.
Develop and execute project plans, timelines, and develop project strategy.
Ensure all CMC activities comply with regulatory requirements (FDA, EMA, etc.).
Prepare and review CMC sections of regulatory submissions, including INDs, NDAs, and BLAs.
Interact with regulatory agencies to address CMC-related queries and provide necessary documentation.
Identify and manage external partners, including CMOs and CROs, including negotiating contracts and managing vendor performance.
Ensure quality and timely delivery of contracted services.
May mentor and develop junior staff members.
Qualifications
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.
Proven track record of successful FIH development, process optimization 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 analytical methods and quality control processes.
Ability to work in a fast-paced, dynamic environment and manage multiple priorities.
Strong analytical and problem-solving skills.
Commitment to maintaining high quality standards.
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 $178,000 to $194,750 depending on skills, competency, and the market demand for your expertise.
#J-18808-Ljbffr