Associate Director, Drug Product
3 months ago
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 Associate Director, Drug Product is responsible for overseeing the development and manufacturing of drug products, ensuring compliance with regulatory standards, and leading cross-functional teams to advance the company's product pipeline. This role requires a strong background in pharmaceutical sciences, drug product development, and regulatory requirements.
About You
Your deep knowledge of formulation science and process development is matched by your proficiency in navigating regulatory landscapes. You excel at managing complex projects, coordinating cross-functional teams, and driving projects from early clinical stage through commercial stages. Your leadership style is collaborative and inclusive, fostering a culture of innovation and continuous improvement. As a strategic thinker and problem solver, you stay ahead of industry trends and leverage emerging technologies to optimize processes and deliver high-quality drug products. 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.
What You'll Do:
- Lead the in-house preclinical formulation development, and drug product development from early clinical stage 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 and scale-up.
- 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, and BLAs.
- Interact with regulatory agencies to address CMC-related queries and provide necessary documentation.
- Provide technical expertise drug product formulation and manufacturing.
- 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.
- Post graduate degree (PhD preferred) in Pharmaceutics, Chemical Engineering, or related field, with 7+ years of experience in pharmaceutical formulation and drug product development.
- Experience with various dosage forms (solid oral, injectable, etc.).
- 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 analytical methods 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.
- Pre-clinical formulation knowledge is strongly preferred.
- 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 $170,000 to $185,250 depending on skills, competency, and the market demand for your expertise.
Eikon is proud to be an equal opportunity employer and will consider all qualified applicants for employment.
In accordance with the Company's duty to provide and maintain a safe workplace, the Company requires all employees to be Fully Vaccinated with one of the FDA approved COVID-19 vaccines, which includes those vaccines that have received the FDA's emergency use authorization. You will be expected to be Fully Vaccinated as of your Start Date. If you believe that you are exempt from this requirement under an applicable law or regulations, including Americans with Disabilities Act and California's Fair Employment and Housing Act, you will need to contact the Company's Human Resources group. For purposes of this section, Fully Vaccinated means (i) the completion of the vaccination regimen as approved by the FDA (by way of example, 2 doses of the Pfizer or Moderna vaccine and 1 dose of the Johnson and Johnson vaccine), and (ii) timely receiving booster vaccination, as recommended by the Centers for Disease Control and Prevention.
We are currently not accepting any new third-party agencies or firms at this time. Please do not forward unsolicited agency resumes to our website, employees or Human Resources. Eikon Therapeutics will not pay fees to any third-party agency or firm associated with unsolicited resumes.
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