Associate Director, Drug Product
24 hours ago
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.
Qualifications
- 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.
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 $170,000 to $185,250 depending on skills, competency, and the market demand for your expertise.
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