About this job
- Industry: Pharmaceutical
- Area of expertise: Research & Development
- Location: United States
What is required?
- Hours per week: 40
- Education level: Professional Master
About this role: Associate Director Drug Product
We are hiring a candidate who will participate in defining phase-appropriate strategies for small molecule drug product development. They will be responsible for oversight of day-to-day management of formulation activities at contract manufacturing organizations. This person will have the opportunity to work on the leading small molecule program in phase II/III.
- Lead drug product development activities and define phase-appropriate strategies for small molecule drug product development and manufacture.
- Participate in developing work scope plans and identifying and selecting drug product formulation development and manufacturing vendors with required capabilities.
- Manage activities, timelines, and budgets at CMO/CROs conducting manufacturing, testing, and packaging activities to meet overall project timelines.
- Monitor work performed by drug product CMOs, including reviews of protocols, reports, raw data, master and executed production records to ensure consistency with project and regulatory requirements and scientific integrity
- Troubleshoot formulation and manufacturing issues as needed.
- Participate in cross-functional development teams as needed.
- Prepare reports for management and identify issues to address with the cross-functional team.
- Author, review and approve GMP documents for clinical supply manufacturing.
- Prepare and review relevant sections of CMC regulatory submissions.
- Support any quality investigations or events and resolve them in a timely manner
- Degree in pharmaceutical sciences or relevant scientific discipline; Ph.D. (preferred) in relevant discipline and 8+ years relevant work experience OR B.S./M.S. in relevant discipline and 12+ years relevant work experience
- Small molecule drug product experience required. Experience in designing and developing solid and liquid oral formulations (such as IR, MR, ODTs) and associated processes for small molecules in support of clinical and preclinical studies.
- Pediatric formulation development experience a plus.
- Experience in designing and optimizing manufacturing processes for oral drug products
- Prior experience managing outsourced development and manufacturing
- In-depth knowledge of pharmaceutical cGMPs, regulatory standards and guidance documents for all phases of drug development
- Able to manage multiple internal and external activities to meet timelines
- Excellent computer, documentation, and organizational skills
- Strong attention to detail, strong problem-solving skills, as well as the ability to work in a cross-functional team environment.
- Strong communication skills, able to work independently and collaborate with key internal and external stakeholders.
- Experience working with cross functional teams (analytical, quality, regulatory, clinical supply, process chemistry etc.)
- Must be flexible in adapting to a changing work environment and offer solutions to program challenges.
- Business travel, domestic and international, to various company offices, CMOs, and partners as required.
Why apply through Brunel? Finding the next step in your career can be a fulltime job in itself. We manage the process for you: from submitting your resume to coordinating interviews to extending offers and assisting with on-boarding. We’ll get you going while you get on with the job.
Join the Brunel Family
Join the Brunel Family
Brunel has a reputation for working with some of the best in the business. That’s what we continually strive for. Over 45 years, we’ve created a global network of interesting clients and talented individuals working together through a vast array of services.
Start applying immediately
Sending an application is quick and easy. Just make sure you have the required documents ready to go.
- Certifications (optional)
- Job references (optional)
- Motivation Letter (optional)
Any questions remaining?
Your consultant, Kenneth McGreevy is happy to clarify anything about this vacancy. When reaching out, use the pub number:
Brunel USA - Boston